<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/NCT04486716</url>
  </required_header>
  <id_info>
    <org_study_id>COMB157GUS07</org_study_id>
    <secondary_id>111,116</secondary_id>
    <nct_id>NCT04486716</nct_id>
  </id_info>
  <brief_title>A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis</brief_title>
  <acronym>OLIKOS</acronym>
  <official_title>A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab&#xD;
      in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm multi-center, study in approximately 100 participants with relapsing&#xD;
      multiple sclerosis who were previously treated with aCD20 mAb therapy. Eligible participants&#xD;
      will receive open label ofatumumab 20 mg subcutaneous monthly for 12 months following initial&#xD;
      loading regimen of 20 milligrams subcutaneous doses on Days 1, 7 and 14. Assessments will&#xD;
      include but are not limited to Magnetic Resonance Imaging (MRI) assessed for quality by&#xD;
      central reading center, multiple Patient Reported Outcome measurements and safety&#xD;
      assessments. Participants that do not continue onto commercial ofatumumab or another therapy&#xD;
      within one month of the End of Study Visit must continue into the safety Follow Up phase,&#xD;
      consisting of every 3 month visits including B cell monitoring until they are able to start&#xD;
      on commercial ofatumumab or switch to another therapy or until their B cells are repleted&#xD;
      defined as a B cell concentration greater than the individual participant's baseline value or&#xD;
      greater than the lower limit of normal. All participants will have a safety follow-up phone&#xD;
      call at 30 days post study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open-label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with no change or reduction in gadolinium enhancing lesions at 12 months</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Magnetic Resonance Imaging (MRI) will be used to measure presence of new or reduction in number of gadolinium enhancing lesions. Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for total CD19+ B cell counts and CD3+CD20+ T cell counts,</measure>
    <time_frame>Baseline up to 6 and 12 months</time_frame>
    <description>Total CD19+ B cell counts cell counts, obtained by fluorescence activated cell sorting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for CD3+CD20+ T cell counts,</measure>
    <time_frame>Baseline up to 6 and 12 months</time_frame>
    <description>CD3+CD20+ T cell counts, obtained by fluorescence activated cell sorting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for Treatment Satisfaction Questionnaire for Medication (TSQM-9)</measure>
    <time_frame>Baseline up to 6 and 12 months</time_frame>
    <description>The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to evaluate the participants' satisfaction with Ofatumumab. The TSQM-9 is a psychometrically sound and valid participant reported outcome to measure participants' satisfaction with medication and a good predictor of adherence across different types of medication and participant population. The TSQM-9 is a 9 item questionnaire having a global satisfaction score ranging from 0-100. The questionnaire consists of 3 domains: satisfaction, convenience and effectiveness (3 items each). The domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline up to 6 and 12 months</time_frame>
    <description>The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from &quot;wish to be dead&quot; to &quot;active suicidal ideation with specific plan and intent.&quot; The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment emergent adverse events</measure>
    <time_frame>Baseline up 13 months (includes 30 day followup) or up to 21 months for patients entering extra safety follow-up</time_frame>
    <description>Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration &gt; the participant's baseline value or &gt; the lower limit of normal, whichever is observed first.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Relapsing Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Ofatumumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml) administered at baseline, Day 7, Day 14 and monthly thereafter</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ofatumumab</intervention_name>
    <description>Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml)</description>
    <arm_group_label>Ofatumumab</arm_group_label>
    <other_name>OMB157</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants eligible for inclusion in this study must meet all of the following criteria:&#xD;
&#xD;
          1. Written informed consent must be obtained before any assessment is performed.&#xD;
&#xD;
          2. Male or female participants aged 18 to 60 years (inclusive) at screening.&#xD;
&#xD;
          3. Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria&#xD;
             (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as defined&#xD;
             by (Lublin et al. 2014).&#xD;
&#xD;
          4. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive).&#xD;
&#xD;
          5. Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1&#xD;
             course):&#xD;
&#xD;
             • Participants currently treated with ocrelizumab must have received (meet all three&#xD;
             criteria below):&#xD;
&#xD;
        1. 2 fully infused initial 300 mg ocrelizumab iv infusions 2. At least 1 fully infused 600&#xD;
        mg ocrelizumab iv infusions 6 months (+/- one month) 3. Last fully infused ocrelizumab dose&#xD;
        must have occurred within 4-9 months prior to baseline&#xD;
&#xD;
        •Participants currently treated with rituximab must have received (meet both criteria&#xD;
        below):&#xD;
&#xD;
          1. At least 2 fully infused courses of rituximab 500 mg - 1000 mg iv every 6 months (+/-&#xD;
             one month).&#xD;
&#xD;
               1. Initial loading regimens of rituximab i.e. 500 mg - 1000 mg on day 1 and on day&#xD;
                  15, are allowed but this is consider a single course and must be followed by&#xD;
                  additional infusion(s) every 6 months (+/- one month)&#xD;
&#xD;
          2. Last fully infused rituximab dose must have occurred within 4-9 months prior to&#xD;
             baseline.&#xD;
&#xD;
        6. Participants discontinuing aCD20 therapy for reasons including, but not limited to:&#xD;
        physician/participant preference, access to commercial drug (e.g. insurance coverage&#xD;
        issues) or for other logistical reasons (such as geographical relocation, travel, etc.) are&#xD;
        eligible for this study. 7. Neurologically stable within 1 month prior to first study drug&#xD;
        administration.&#xD;
&#xD;
        8. Must be able to use a smart device or have a caregiver that can assist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants meeting any of the following criteria are not eligible for inclusion in this&#xD;
        study:&#xD;
&#xD;
          1. Participants that have demonstrated suboptimal response to aCD20 therapy to include:&#xD;
&#xD;
             a. Signs of MRI activity, defined as ≥ 2 active Gd+ T1 lesions, or any new or newly&#xD;
             enlarging T2 lesions, documented within the past 6 months&#xD;
&#xD;
               -  If a prior MRI within the last 6 months is not available, then new or newly&#xD;
                  enlarging T2 lesions should be considered &quot;not documented&quot; and the patient may&#xD;
                  continue screening b. Documented relapse while on stable, previous aCD20&#xD;
                  treatment.&#xD;
&#xD;
               -  Relapses during the first 3 months of intravenous aCD20 therapy are allowable if&#xD;
                  the participant is then relapse-free for the 12 months following the relapse&#xD;
                  while on intravenous aCD20 therapy c. Any signs of clinical worsening as measured&#xD;
                  by EDSS or any clinical measure documented within the last 6 months&#xD;
&#xD;
          2. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse&#xD;
             events:&#xD;
&#xD;
               1. Severe infusion-related reactions (Grade 3 or above)&#xD;
&#xD;
               2. Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratory&#xD;
                  infections or the need for ≥ 2 courses of antibiotics since starting aCD20&#xD;
                  therapy, if the Investigator believes this is related to therapy.&#xD;
&#xD;
               3. Decreased IgG requiring treatment with Intravenous immunoglobulin&#xD;
&#xD;
          3. Participants with primary progressive MS (Polman et al 2011) or SPMS without disease&#xD;
             activity (Lublin et al 2014).&#xD;
&#xD;
          4. Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015).&#xD;
&#xD;
          5. Pregnant or nursing (lactating) women&#xD;
&#xD;
          6. Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using highly effective methods of contraception&#xD;
             during dosing and for at least 6 months after stopping study medication.&#xD;
&#xD;
          7. Participants with active chronic disease (or stable but treated with immune therapy)&#xD;
             of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's&#xD;
             syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome&#xD;
             (hereditary immune deficiency, drug-induced immune deficiency).&#xD;
&#xD;
          8. Participants with active systemic bacterial, viral or fungal infections, or known to&#xD;
             have acquired immunodeficiency syndrome (AIDS).&#xD;
&#xD;
          9. Participants with neurological symptoms consistent with PML or with confirmed PML.&#xD;
&#xD;
         10. Participants at risk of developing or having reactivation of syphilis or tuberculosis&#xD;
&#xD;
         11. Participants at risk of developing or having reactivation of hepatitis.&#xD;
&#xD;
         12. Have received any live or live-attenuated vaccines (including for varicella-zoster&#xD;
             virus or measles) within 4 weeks prior to first study drug administration. a. There is&#xD;
             presently no contraindication for the use of an inactivated, viral-vector-or mRNA&#xD;
             based Sars-CoV-2 vaccine in patients who are immunocompromised. However, different&#xD;
             Sars-CoV-2 vaccines may have various mechanisms of action and different associated&#xD;
             potential risks. Please review local prescribing information of any specific&#xD;
             Sars-CoV-2 vaccine and comply with local prescribing information requirements for&#xD;
             specific contra-indications and special warnings and precautions for use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Foxboro</city>
        <state>Massachusetts</state>
        <zip>02035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wellesley</city>
        <state>Massachusetts</state>
        <zip>02481</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guaynabo</city>
        <zip>00968</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ofatumumab</keyword>
  <keyword>Relapsing multiple sclerosis</keyword>
  <keyword>MS</keyword>
  <keyword>RMS</keyword>
  <keyword>CIS</keyword>
  <keyword>RRMS</keyword>
  <keyword>SPM</keyword>
  <keyword>ocrelizumab</keyword>
  <keyword>MRI</keyword>
  <keyword>CD19 B</keyword>
  <keyword>adult,</keyword>
  <keyword>OMB157</keyword>
  <keyword>open-label</keyword>
  <keyword>rituximab</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>
  </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 www.clinicalstudydatarequest.com</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04486716
org study id: COMB157GUS07
secondary id: 111,116
nct id: NCT04486716
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab
      in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy
This is a single-arm multi-center, study in approximately 100 participants with relapsing
      multiple sclerosis who were previously treated with aCD20 mAb therapy. Eligible participants
      will receive open label ofatumumab 20 mg subcutaneous monthly for 12 months following initial
      loading regimen of 20 milligrams subcutaneous doses on Days 1, 7 and 14. Assessments will
      include but are not limited to Magnetic Resonance Imaging (MRI) assessed for quality by
      central reading center, multiple Patient Reported Outcome measurements and safety
      assessments. Participants that do not continue onto commercial ofatumumab or another therapy
      within one month of the End of Study Visit must continue into the safety Follow Up phase,
      consisting of every 3 month visits including B cell monitoring until they are able to start
      on commercial ofatumumab or switch to another therapy or until their B cells are repleted
      defined as a B cell concentration greater than the individual participant's baseline value or
      greater than the lower limit of normal. All participants will have a safety follow-up phone
      call at 30 days post study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open-label
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with no change or reduction in gadolinium enhancing lesions at 12 months
time frame: Baseline up to 12 months
description: Magnetic Resonance Imaging (MRI) will be used to measure presence of new or reduction in number of gadolinium enhancing lesions. Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol.
measure: Change from baseline for total CD19+ B cell counts and CD3+CD20+ T cell counts,
time frame: Baseline up to 6 and 12 months
description: Total CD19+ B cell counts cell counts, obtained by fluorescence activated cell sorting
measure: Change from baseline for CD3+CD20+ T cell counts,
time frame: Baseline up to 6 and 12 months
description: CD3+CD20+ T cell counts, obtained by fluorescence activated cell sorting
measure: Change from baseline for Treatment Satisfaction Questionnaire for Medication (TSQM-9)
time frame: Baseline up to 6 and 12 months
description: The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to evaluate the participants' satisfaction with Ofatumumab. The TSQM-9 is a psychometrically sound and valid participant reported outcome to measure participants' satisfaction with medication and a good predictor of adherence across different types of medication and participant population. The TSQM-9 is a 9 item questionnaire having a global satisfaction score ranging from 0-100. The questionnaire consists of 3 domains: satisfaction, convenience and effectiveness (3 items each). The domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
measure: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline up to 6 and 12 months
description: The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
measure: Number of participants with treatment emergent adverse events
time frame: Baseline up 13 months (includes 30 day followup) or up to 21 months for patients entering extra safety follow-up
description: Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration > the participant's baseline value or > the lower limit of normal, whichever is observed first.
arm group label: Ofatumumab
arm group type: Experimental
description: Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml) administered at baseline, Day 7, Day 14 and monthly thereafter
intervention type: Drug
intervention name: Ofatumumab
description: Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml)
arm group label: Ofatumumab
other name: OMB157
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Ofatumumab
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 www.clinicalstudydatarequest.com
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)