<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03249714</url>
  </required_header>
  <id_info>
    <org_study_id>COMB157G1301</org_study_id>
    <nct_id>NCT03249714</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab</brief_title>
  <official_title>A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with&#xD;
      relapsing multiple sclerosis (RMS) in Japan and the other countries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study had 2 parts: A controlled Core and an open-label Extension.&#xD;
&#xD;
        -  Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group,&#xD;
           multicenter study evaluated the efficacy, safety and tolerability and PK of ofatumumab&#xD;
           in patients with RMS.&#xD;
&#xD;
        -  Extension part: The Core part was followed by an Extension part in which all patients&#xD;
           received open-label ofatumumab. In the Extension part, patients were treated for at&#xD;
           least 24 weeks and no longer than 48 weeks.&#xD;
&#xD;
      Sixty-four patients were randomized in a 2:1 ratio to ofatumumab or placebo in the Core part;&#xD;
      half of the study patients were from Japan and the other half from the other countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Actual">July 29, 2020</completion_date>
  <primary_completion_date type="Actual">December 26, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1), and the treatment-by-region interaction term as explanatory variables, and the patient's number of scans as the offset variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Number of new/enlarging T2 lesions on the last available MRI scan in the Core Part (up to Week 24) relative to baseline, adjusted for different follow-up times. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log-link. The model included each patient's last available number of new or enlarging T2 lesions relative to baseline as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1), and baseline volume of T2 lesions as explanatory variables, and the patient's follow-up time as the offset variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Relapse Rate (ARR) - Core Part</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR was calculated as a rate for population, rather than at patient-level, using a negative binomial regression model with log-link. The model included each patient's number of confirmed relapses as the response variable, and treatment and region as explanatory variables, and the patient's follow-up time as the offset variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part</measure>
    <time_frame>Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24</time_frame>
    <description>Blood samples were collected at the scheduled visit. Summary statistics of PK concentrations from trough samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B-cell Counts - Japan vs Non-Japan - Core Part</measure>
    <time_frame>Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24</time_frame>
    <description>Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part</measure>
    <time_frame>Week 24 up to Week 48</time_frame>
    <description>Total number of Gd-enhancing T1 lesions per scan during the Extension Part (up to Week 48) calculated as a rate for population, rather than at patient-level. It was calculated as sum of each patient's total number of Gd-enhancing T1 lesions across scans at Week 36 and 48, divided by sum of each patient's total number of scans.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part</measure>
    <time_frame>Week 24 up to Week 48</time_frame>
    <description>Number of new/enlarging T2 lesions on the last available MRI scan in the Extension Part (up to Week 48) relative to Week 24, adjusted for different follow-up times. Annualized rate of new or enlarging T2 lesions was calculated by dividing the sum of each patient's number of new or enlarging T2 lesions relative to Week 24 by the sum of each patient's number of MRI assessment days during the Extension part, and then multiplying it by 365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Relapse Rate (ARR) - Extension Part</measure>
    <time_frame>Week 24 up to Week 48</time_frame>
    <description>ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR (time-based) was calculated by summing each patient's number of confirmed relapses observed during the Extension part, divided by the total number of each patient's days in a study of all patients during the Extension part, and multiplied by 365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part</measure>
    <time_frame>Weeks 24, 28, 36, 48</time_frame>
    <description>Blood samples were collected at the scheduled visits. Summary statistics of PK concentrations from trough samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B-cell Counts - Extension Part</measure>
    <time_frame>Weeks 24, 36 and 48</time_frame>
    <description>Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Confirmed Relapse - Core and Extension Parts</measure>
    <time_frame>Baseline up to Week 48</time_frame>
    <description>A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Relapsing Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>OMB 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ofatumumab 20 mg subcutaneous injection on Days 1,7, 14 and every 4 weeks for 24 weeks in Core. Core placebo patients received loading dose at Weeks 25 and 26 and then all Extension patients received dose every 4 Weeks up to Week 48.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo subcutaneous injection matching to ofatumumab every 4 weeks for 24 weeks in Core</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ofatumumab</intervention_name>
    <description>Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content)</description>
    <arm_group_label>OMB 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo of ofatumumab</intervention_name>
    <description>Matching placebo in pre-filled syringes</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of multiple sclerosis (MS)&#xD;
&#xD;
          -  Relapsing MS (RMS)&#xD;
&#xD;
          -  At least 1 appearance of a new neurological abnormality or worsening of pre-existing&#xD;
             neurological abnormality during the previous 2 years prior to Screening AND an MRI&#xD;
             activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the&#xD;
             previous 1 year prior to randomization&#xD;
&#xD;
          -  EDSS score of 0 to 5.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary progressive MS or SPMS without disease activity&#xD;
&#xD;
          -  Patients with an active chronic disease of the immune system other than MS&#xD;
&#xD;
          -  Patients at risk of developing or having reactivation of hepatitis&#xD;
&#xD;
          -  Patients with active systemic infections or with neurological findings consistent with&#xD;
             PML&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toon-city</city>
        <state>Ehime</state>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fukuoka city</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sapporo city</city>
        <state>Hokkaido</state>
        <zip>063-0005</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sendai city</city>
        <state>Miyagi</state>
        <zip>980 8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sendai city</city>
        <state>Miyagi</state>
        <zip>983 8512</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kawagoe</city>
        <state>Saitama</state>
        <zip>350 8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kodaira</city>
        <state>Tokyo</state>
        <zip>187-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160 8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chiba</city>
        <zip>260 8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Niigata</city>
        <zip>951 8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka</city>
        <zip>556-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kazan</city>
        <zip>420021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=969</url>
    <description>A Plain Language Trial Summary is available on novctrd.com</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>July 23, 2021</results_first_submitted>
  <results_first_submitted_qc>December 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2022</results_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>double-blind</keyword>
  <keyword>placebo controlled</keyword>
  <keyword>ofatumumab</keyword>
  <keyword>relapsing multiple sclerosis</keyword>
  <keyword>Japanese patients</keyword>
  <keyword>MS</keyword>
  <keyword>RMS</keyword>
  <keyword>adult</keyword>
  <keyword>OMB157</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ofatumumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03249714/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03249714/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients where randomized in a 2:1 ratio to ofatumumab or placebo in the Core Part</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>OMB 20 mg</title>
          <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo - OMB 20 mg</title>
          <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind Treatment (Core Part)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject/guardian decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label Treatment (Extension Part)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OMB 20 mg</title>
          <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="64"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.0" spread="9.49"/>
                    <measurement group_id="B2" value="35.5" spread="8.93"/>
                    <measurement group_id="B3" value="35.2" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Country of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of relapses in the past 12 months prior to screening</title>
          <description>Reported numbers are from investigator records.</description>
          <units>Number of relapses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.6" spread="0.90"/>
                    <measurement group_id="B2" value="1.2" spread="0.70"/>
                    <measurement group_id="B3" value="1.5" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Gd-enhancing T1 lesions</title>
          <description>Magnetic Resonance Imaging (MRI) scans of the brain were were read by the central MRI reading center. The central reading center was blinded with no access to information on treatment assignments</description>
          <population>n=number of participants with non-missing values</population>
          <units>lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.3" spread="2.62"/>
                    <measurement group_id="B2" value="1.0" spread="1.47"/>
                    <measurement group_id="B3" value="1.2" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part</title>
        <description>Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part</title>
          <description>Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.</description>
          <population>Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)</population>
          <units>lesions per scan</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0670" lower_limit="0.027" upper_limit="0.167"/>
                    <measurement group_id="O2" value="1.0413" lower_limit="0.465" upper_limit="2.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>negative binominal regression model</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.064</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.018</ci_lower_limit>
            <ci_upper_limit>0.232</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part</title>
        <description>Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1), and the treatment-by-region interaction term as explanatory variables, and the patient's number of scans as the offset variable.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients</description>
          </group>
          <group group_id="O2">
            <title>Placebo Japan</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients</description>
          </group>
          <group group_id="O3">
            <title>OMB 20 mg Non-Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter&#xD;
- non-Japanese patients</description>
          </group>
          <group group_id="O4">
            <title>Placebo Non-Japan</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part</title>
          <description>Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1), and the treatment-by-region interaction term as explanatory variables, and the patient's number of scans as the offset variable.</description>
          <population>Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)</population>
          <units>lesions per scan</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1999" lower_limit="0.082" upper_limit="0.485"/>
                    <measurement group_id="O2" value="1.4682" lower_limit="0.538" upper_limit="4.004"/>
                    <measurement group_id="O3" value="0.0000" lower_limit="0.0000" upper_limit="0.0000"/>
                    <measurement group_id="O4" value="0.6774" lower_limit="0.234" upper_limit="1.962"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>Statistical significance (2-sided) at the 0.05 level</p_value_desc>
            <method>negative binomial regression</method>
            <param_type>rate ratio</param_type>
            <param_value>0.136</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.036</ci_lower_limit>
            <ci_upper_limit>0.513</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>negative binominal regression</method>
            <method_desc>Indicates statistical significance (2-sided) at the 0.05 level.</method_desc>
            <param_type>rate ratio</param_type>
            <param_value>0.000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit>0.000</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part</title>
        <description>Number of new/enlarging T2 lesions on the last available MRI scan in the Core Part (up to Week 24) relative to baseline, adjusted for different follow-up times. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log-link. The model included each patient's last available number of new or enlarging T2 lesions relative to baseline as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1), and baseline volume of T2 lesions as explanatory variables, and the patient's follow-up time as the offset variable.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part</title>
          <description>Number of new/enlarging T2 lesions on the last available MRI scan in the Core Part (up to Week 24) relative to baseline, adjusted for different follow-up times. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log-link. The model included each patient's last available number of new or enlarging T2 lesions relative to baseline as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or &gt;=1), and baseline volume of T2 lesions as explanatory variables, and the patient's follow-up time as the offset variable.</description>
          <population>Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)</population>
          <units>T2 lesions per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7344" lower_limit="2.354" upper_limit="5.925"/>
                    <measurement group_id="O2" value="13.1533" lower_limit="7.197" upper_limit="24.039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>negative binominal regression</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.284</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.130</ci_lower_limit>
            <ci_upper_limit>0.620</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Relapse Rate (ARR) - Core Part</title>
        <description>ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR was calculated as a rate for population, rather than at patient-level, using a negative binomial regression model with log-link. The model included each patient's number of confirmed relapses as the response variable, and treatment and region as explanatory variables, and the patient's follow-up time as the offset variable.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Relapse Rate (ARR) - Core Part</title>
          <description>ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR was calculated as a rate for population, rather than at patient-level, using a negative binomial regression model with log-link. The model included each patient's number of confirmed relapses as the response variable, and treatment and region as explanatory variables, and the patient's follow-up time as the offset variable.</description>
          <population>Full analysis set</population>
          <units>relapses in a year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2640" lower_limit="0.111" upper_limit="0.629"/>
                    <measurement group_id="O2" value="0.6286" lower_limit="0.276" upper_limit="1.430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.119</p_value>
            <method>negative binominal regression</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.420</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.141</ci_lower_limit>
            <ci_upper_limit>1.250</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part</title>
        <description>Blood samples were collected at the scheduled visit. Summary statistics of PK concentrations from trough samples.</description>
        <time_frame>Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients</description>
          </group>
          <group group_id="O2">
            <title>OMB 20 mg Non-Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non - Japanese patients</description>
          </group>
          <group group_id="O3">
            <title>OMB 20 mg - All Patients</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part</title>
          <description>Blood samples were collected at the scheduled visit. Summary statistics of PK concentrations from trough samples.</description>
          <population>Full analysis set</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline n=21,22,43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.07"/>
                    <measurement group_id="O2" value="0.9" spread=".39"/>
                    <measurement group_id="O3" value=".06" spread=".28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 n=21,22,43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".43" spread=".38"/>
                    <measurement group_id="O2" value=".24" spread=".32"/>
                    <measurement group_id="O3" value="0.33" spread=".36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 n=21,22,43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".88" spread=".40"/>
                    <measurement group_id="O2" value=".60" spread=".46"/>
                    <measurement group_id="O3" value=".73" spread=".45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 n=21,22,43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".84" spread=".39"/>
                    <measurement group_id="O2" value="0.48" spread=".34"/>
                    <measurement group_id="O3" value="0.66" spread=".40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 n=21,22,43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" spread=".63"/>
                    <measurement group_id="O2" value="1.71" spread="1.00"/>
                    <measurement group_id="O3" value="1.93" spread=".86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 n=21,22,43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" spread=".86"/>
                    <measurement group_id="O2" value="2.03" spread="1.14"/>
                    <measurement group_id="O3" value="2.35" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 n=20,21,41</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".66" spread=".62"/>
                    <measurement group_id="O2" value="0.38" spread=".38"/>
                    <measurement group_id="O3" value=".51" spread=".53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 n=20,20,40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".84" spread=".60"/>
                    <measurement group_id="O2" value=".64" spread=".46"/>
                    <measurement group_id="O3" value=".74" spread=".54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>B-cell Counts - Japan vs Non-Japan - Core Part</title>
        <description>Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.</description>
        <time_frame>Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24</time_frame>
        <population>Safety set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients</description>
          </group>
          <group group_id="O2">
            <title>Placebo Japan</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients</description>
          </group>
          <group group_id="O3">
            <title>OMB 20 mg Non-Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter- non-Japanese participants</description>
          </group>
          <group group_id="O4">
            <title>Placebo Non-Japan</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients</description>
          </group>
        </group_list>
        <measure>
          <title>B-cell Counts - Japan vs Non-Japan - Core Part</title>
          <description>Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.</description>
          <population>Safety set</population>
          <units>cells/uL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline n=21,11,22,9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207" lower_limit="41" upper_limit="566"/>
                    <measurement group_id="O2" value="205" lower_limit="81" upper_limit="814"/>
                    <measurement group_id="O3" value="208" lower_limit="78" upper_limit="419"/>
                    <measurement group_id="O4" value="244" lower_limit="81" upper_limit="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 n=21,11,21,9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1" upper_limit="69"/>
                    <measurement group_id="O2" value="319.0" lower_limit="127" upper_limit="629"/>
                    <measurement group_id="O3" value="14.0" lower_limit="1" upper_limit="283"/>
                    <measurement group_id="O4" value="292.0" lower_limit="79" upper_limit="797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 n=20,10,14,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1" upper_limit="50"/>
                    <measurement group_id="O2" value="216.5" lower_limit="91" upper_limit="658"/>
                    <measurement group_id="O3" value="8.5" lower_limit="0" upper_limit="300"/>
                    <measurement group_id="O4" value="257.0" lower_limit="124" upper_limit="533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 n=21,11,22,9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="209.0" lower_limit="61" upper_limit="514"/>
                    <measurement group_id="O3" value="3.5" lower_limit="0" upper_limit="37"/>
                    <measurement group_id="O4" value="228.0" lower_limit="15" upper_limit="319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 n=21,11,19,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O2" value="266.0" lower_limit="82" upper_limit="496"/>
                    <measurement group_id="O3" value="3.0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O4" value="226.0" lower_limit="132" upper_limit="323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 n=21,10,21,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O2" value="235.5" lower_limit="178" upper_limit="489"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="O4" value="179.5" lower_limit="15" upper_limit="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 n=20,10,18,9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O2" value="211.0" lower_limit="130" upper_limit="464"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O4" value="200.0" lower_limit="59" upper_limit="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 n=19,8,19,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="227.5" lower_limit="79" upper_limit="462"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="15"/>
                    <measurement group_id="O4" value="224.5" lower_limit="106" upper_limit="523"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part</title>
        <description>Total number of Gd-enhancing T1 lesions per scan during the Extension Part (up to Week 48) calculated as a rate for population, rather than at patient-level. It was calculated as sum of each patient's total number of Gd-enhancing T1 lesions across scans at Week 36 and 48, divided by sum of each patient's total number of scans.</description>
        <time_frame>Week 24 up to Week 48</time_frame>
        <population>Extension full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo (Core) - OMB 20 mg (Extension)</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part</title>
          <description>Total number of Gd-enhancing T1 lesions per scan during the Extension Part (up to Week 48) calculated as a rate for population, rather than at patient-level. It was calculated as sum of each patient's total number of Gd-enhancing T1 lesions across scans at Week 36 and 48, divided by sum of each patient's total number of scans.</description>
          <population>Extension full analysis set</population>
          <units>lesions per scan</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.027"/>
                    <measurement group_id="O2" value="0.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part</title>
        <description>Number of new/enlarging T2 lesions on the last available MRI scan in the Extension Part (up to Week 48) relative to Week 24, adjusted for different follow-up times. Annualized rate of new or enlarging T2 lesions was calculated by dividing the sum of each patient's number of new or enlarging T2 lesions relative to Week 24 by the sum of each patient's number of MRI assessment days during the Extension part, and then multiplying it by 365.25.</description>
        <time_frame>Week 24 up to Week 48</time_frame>
        <population>Extension full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo (Core) - OMB 20 mg (Extension)</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part</title>
          <description>Number of new/enlarging T2 lesions on the last available MRI scan in the Extension Part (up to Week 48) relative to Week 24, adjusted for different follow-up times. Annualized rate of new or enlarging T2 lesions was calculated by dividing the sum of each patient's number of new or enlarging T2 lesions relative to Week 24 by the sum of each patient's number of MRI assessment days during the Extension part, and then multiplying it by 365.25.</description>
          <population>Extension full analysis set</population>
          <units>T2 lesions per year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.230"/>
                    <measurement group_id="O2" value="0.813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Relapse Rate (ARR) - Extension Part</title>
        <description>ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR (time-based) was calculated by summing each patient's number of confirmed relapses observed during the Extension part, divided by the total number of each patient's days in a study of all patients during the Extension part, and multiplied by 365.25.</description>
        <time_frame>Week 24 up to Week 48</time_frame>
        <population>Extension full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo (Core) - OMB 20 mg (Extension)</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Relapse Rate (ARR) - Extension Part</title>
          <description>ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR (time-based) was calculated by summing each patient's number of confirmed relapses observed during the Extension part, divided by the total number of each patient's days in a study of all patients during the Extension part, and multiplied by 365.25.</description>
          <population>Extension full analysis set</population>
          <units>relapses in a year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.081"/>
                    <measurement group_id="O2" value="0.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part</title>
        <description>Blood samples were collected at the scheduled visits. Summary statistics of PK concentrations from trough samples.</description>
        <time_frame>Weeks 24, 28, 36, 48</time_frame>
        <population>Extension full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks - Japanese patients</description>
          </group>
          <group group_id="O2">
            <title>OMB 20 mg Non-Japan</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks - non-Japanese patients</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part</title>
          <description>Blood samples were collected at the scheduled visits. Summary statistics of PK concentrations from trough samples.</description>
          <population>Extension full analysis set</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".84" spread=".60"/>
                    <measurement group_id="O2" value=".64" spread=".46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 n=19,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread=".36"/>
                    <measurement group_id="O2" value=".61" spread=".48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 n=19,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".97" spread=".53"/>
                    <measurement group_id="O2" value=".72" spread=".56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 n=18,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread=".56"/>
                    <measurement group_id="O2" value=".94" spread=".76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>B-cell Counts - Extension Part</title>
        <description>Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.</description>
        <time_frame>Weeks 24, 36 and 48</time_frame>
        <population>Extension safety set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo (Core) - OMB 20 mg (Extension)</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>B-cell Counts - Extension Part</title>
          <description>Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.</description>
          <population>Extension safety set</population>
          <units>cells/uL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24 n=40,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="15"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 n=38, 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 n=38,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Confirmed Relapse - Core and Extension Parts</title>
        <description>A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).</description>
        <time_frame>Baseline up to Week 48</time_frame>
        <population>Extension full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OMB 20 mg</title>
            <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo (Core) - OMB 20mg (Extension)</title>
            <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Confirmed Relapse - Core and Extension Parts</title>
          <description>A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).</description>
          <population>Extension full analysis set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;Week 12 to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;Week 24 to Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;Week 36 to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OMB 20mg Core</title>
          <description>CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter</description>
        </group>
        <group group_id="E2">
          <title>Placebo Core</title>
          <description>CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter</description>
        </group>
        <group group_id="E3">
          <title>OMB 20mg Continued</title>
          <description>EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks</description>
        </group>
        <group group_id="E4">
          <title>OMB 20mg Switched (From Placebo)</title>
          <description>EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic inflammatory demyelinating polyradiculoneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Physical deconditioning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection related reaction</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Glucose urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>+ 1 862 778 8300</phone>
      <email>Novartis.email@Novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249714
org study id: COMB157G1301
nct id: NCT03249714
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with
      relapsing multiple sclerosis (RMS) in Japan and the other countries
This study had 2 parts: A controlled Core and an open-label Extension.

        -  Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group,
           multicenter study evaluated the efficacy, safety and tolerability and PK of ofatumumab
           in patients with RMS.

        -  Extension part: The Core part was followed by an Extension part in which all patients
           received open-label ofatumumab. In the Extension part, patients were treated for at
           least 24 weeks and no longer than 48 weeks.

      Sixty-four patients were randomized in a 2:1 ratio to ofatumumab or placebo in the Core part;
      half of the study patients were from Japan and the other half from the other countries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part
time frame: Baseline up to Week 24
description: Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or >=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.
measure: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part
time frame: Baseline up to Week 24
description: Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or >=1), and the treatment-by-region interaction term as explanatory variables, and the patient's number of scans as the offset variable.
measure: Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part
time frame: Baseline up to Week 24
description: Number of new/enlarging T2 lesions on the last available MRI scan in the Core Part (up to Week 24) relative to baseline, adjusted for different follow-up times. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log-link. The model included each patient's last available number of new or enlarging T2 lesions relative to baseline as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or >=1), and baseline volume of T2 lesions as explanatory variables, and the patient's follow-up time as the offset variable.
measure: Annualized Relapse Rate (ARR) - Core Part
time frame: Baseline up to Week 24
description: ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR was calculated as a rate for population, rather than at patient-level, using a negative binomial regression model with log-link. The model included each patient's number of confirmed relapses as the response variable, and treatment and region as explanatory variables, and the patient's follow-up time as the offset variable.
measure: Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
time frame: Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24
description: Blood samples were collected at the scheduled visit. Summary statistics of PK concentrations from trough samples.
measure: B-cell Counts - Japan vs Non-Japan - Core Part
time frame: Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24
description: Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.
measure: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part
time frame: Week 24 up to Week 48
description: Total number of Gd-enhancing T1 lesions per scan during the Extension Part (up to Week 48) calculated as a rate for population, rather than at patient-level. It was calculated as sum of each patient's total number of Gd-enhancing T1 lesions across scans at Week 36 and 48, divided by sum of each patient's total number of scans.
measure: Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part
time frame: Week 24 up to Week 48
description: Number of new/enlarging T2 lesions on the last available MRI scan in the Extension Part (up to Week 48) relative to Week 24, adjusted for different follow-up times. Annualized rate of new or enlarging T2 lesions was calculated by dividing the sum of each patient's number of new or enlarging T2 lesions relative to Week 24 by the sum of each patient's number of MRI assessment days during the Extension part, and then multiplying it by 365.25.
measure: Annualized Relapse Rate (ARR) - Extension Part
time frame: Week 24 up to Week 48
description: ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR (time-based) was calculated by summing each patient's number of confirmed relapses observed during the Extension part, divided by the total number of each patient's days in a study of all patients during the Extension part, and multiplied by 365.25.
measure: Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
time frame: Weeks 24, 28, 36, 48
description: Blood samples were collected at the scheduled visits. Summary statistics of PK concentrations from trough samples.
measure: B-cell Counts - Extension Part
time frame: Weeks 24, 36 and 48
description: Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.
measure: Participants With Confirmed Relapse - Core and Extension Parts
time frame: Baseline up to Week 48
description: A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).
arm group label: OMB 20 mg
arm group type: Experimental
description: Ofatumumab 20 mg subcutaneous injection on Days 1,7, 14 and every 4 weeks for 24 weeks in Core. Core placebo patients received loading dose at Weeks 25 and 26 and then all Extension patients received dose every 4 Weeks up to Week 48.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo subcutaneous injection matching to ofatumumab every 4 weeks for 24 weeks in Core
intervention type: Drug
intervention name: Ofatumumab
description: Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content)
arm group label: OMB 20 mg
intervention type: Drug
intervention name: Matching placebo of ofatumumab
description: Matching placebo in pre-filled syringes
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
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country: Japan
country: Russian Federation
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=969
description: A Plain Language Trial Summary is available on novctrd.com
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Ofatumumab
mesh term: Antibodies, Monoclonal
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 