<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/NCT02988674</url>
  </required_header>
  <id_info>
    <org_study_id>P15-672</org_study_id>
    <nct_id>NCT02988674</nct_id>
  </id_info>
  <brief_title>A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation</brief_title>
  <acronym>Adherence</acronym>
  <official_title>Prospective, Multi-Center, Observational, Program to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to access retention rate, persistence and adherence in&#xD;
      population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis&#xD;
      (PsA)) participants treated with adalimumab in routine clinical settings in the Russian&#xD;
      Federation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">October 16, 2019</completion_date>
  <primary_completion_date type="Actual">October 16, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants on adalimumab therapy</measure>
    <time_frame>Up to 30 days after administering last dose in the study (52 weeks)</time_frame>
    <description>This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in RA and SpA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants on adalimumab therapy</measure>
    <time_frame>Up to 30 days after administering last dose in the study (52 weeks)</time_frame>
    <description>This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in rheumatoid arthritis (RA) and SpA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing medication persistence</measure>
    <time_frame>Up to 48 weeks of treatment period</time_frame>
    <description>Medication persistence is defined as the duration of time from initiation to discontinuation of therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing medication adherence</measure>
    <time_frame>Up to 48 weeks of treatment period</time_frame>
    <description>Medication adherence is defined as the extent to which a participant acts in accordance with the prescribed interval and dose of a dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of disease activity in participants with PsA</measure>
    <time_frame>Up to 48 weeks of treatment period</time_frame>
    <description>This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of disease activity in participants with AS</measure>
    <time_frame>Up to 48 weeks of treatment period</time_frame>
    <description>This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">139</enrollment>
  <condition>Spondylarthritis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Ankylosing Spondylitis (AS)</condition>
  <arm_group>
    <arm_group_label>Participants with Spondylarthritis</arm_group_label>
    <description>Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) participants treated with&#xD;
        adalimumab in routine clinical settings in the Russian Federation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of AS or PsA.&#xD;
&#xD;
          -  Planned prescription or prescribed no more than 1 month before to enrolment therapy&#xD;
             with adalimumab. Treatment has to be prescribed according to the local product label&#xD;
             and prescription guidelines.&#xD;
&#xD;
          -  At the moment of start of treatment with adalimumab moderate/severe AS or PsA (BASDAI&#xD;
             &gt; 4 for AS; DAS28 &gt;3,2 for PsA).&#xD;
&#xD;
          -  Negative result of tuberculosis (TB) screening test and TB specialist permission to&#xD;
             start biologic therapy.&#xD;
&#xD;
          -  Authorization (Consent) for Use/Disclosure of Data signed by the participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has contraindications for the treatment with adalimumab (please see the latest version&#xD;
             of the locally approved label).&#xD;
&#xD;
          -  Participants who are unable to walk and perform basic self-care activities either due&#xD;
             to SpA or a comorbid condition.&#xD;
&#xD;
          -  Any biologic drugs taken over before 3 months of enrolment to the study.&#xD;
&#xD;
          -  Previous participation in this program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025</name>
      <address>
        <city>Kemerovo</city>
        <state>Kemerovskaya Oblast</state>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>119049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivanovo Regional Clinical Hosp /ID# 167028</name>
      <address>
        <city>Ivanovo</city>
        <zip>153040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institution KhMAO-Ugra /ID# 154381</name>
      <address>
        <city>Khanty-mansiysk</city>
        <zip>628011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Clinical policlinic /ID# 154374</name>
      <address>
        <city>Moscow</city>
        <zip>107023</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Research Institute /ID# 154375</name>
      <address>
        <city>Moscow</city>
        <zip>111123</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Rheum /ID# 154378</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advisory-diagnostic Hospital /ID# 154382</name>
      <address>
        <city>Moscow</city>
        <zip>117041</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Clinical Hospital /ID# 154373</name>
      <address>
        <city>Moscow</city>
        <zip>119049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GBUZ Republican Hospital /ID# 167029</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smolensk station JSC Russian R /ID# 167027</name>
      <address>
        <city>Smolensk</city>
        <zip>214025</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nort-Western State Medical Uni /ID# 154376</name>
      <address>
        <city>St. Petersburg</city>
        <zip>191015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tula Regional Clinical Hospita /ID# 155539</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavi State Medical Univer /ID# 154383</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/adalimumab_P15-672.pdf</url>
    <description>clinical study report synopsis</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adalimumab</keyword>
  <keyword>Ankylosing spondylitis</keyword>
  <keyword>Psoriatic arthritis</keyword>
  <keyword>Spondylarthritis</keyword>
  <keyword>Humira®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02988674
org study id: P15-672
nct id: NCT02988674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this study is to access retention rate, persistence and adherence in
      population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis
      (PsA)) participants treated with adalimumab in routine clinical settings in the Russian
      Federation.
observational model: Cohort
time perspective: Prospective
measure: Proportion of participants on adalimumab therapy
time frame: Up to 30 days after administering last dose in the study (52 weeks)
description: This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in RA and SpA.
measure: Number of participants on adalimumab therapy
time frame: Up to 30 days after administering last dose in the study (52 weeks)
description: This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in rheumatoid arthritis (RA) and SpA.
measure: Assessing medication persistence
time frame: Up to 48 weeks of treatment period
description: Medication persistence is defined as the duration of time from initiation to discontinuation of therapy.
measure: Assessing medication adherence
time frame: Up to 48 weeks of treatment period
description: Medication adherence is defined as the extent to which a participant acts in accordance with the prescribed interval and dose of a dosing.
measure: Change of disease activity in participants with PsA
time frame: Up to 48 weeks of treatment period
description: This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA.
measure: Change of disease activity in participants with AS
time frame: Up to 48 weeks of treatment period
description: This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS.
arm group label: Participants with Spondylarthritis
description: Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Russian Federation
url: https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/adalimumab_P15-672.pdf
description: clinical study report synopsis
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
sharing ipd: Undecided