<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/NCT02251860</url>
  </required_header>
  <id_info>
    <org_study_id>ML29087</org_study_id>
    <nct_id>NCT02251860</nct_id>
  </id_info>
  <brief_title>Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice</brief_title>
  <acronym>ARATA</acronym>
  <official_title>A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chugai Pharma Europe Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      ARATA is a prospective, non-interventional, multicenter, observational study in Germany to&#xD;
      evaluate the long-term effectiveness and tolerability of subcutaneously administered&#xD;
      tocilizumab in participants with rheumatoid arthritis in daily clinical practice.&#xD;
      Participants will be followed over an observation period of up to 2 years after the initial&#xD;
      injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2014</start_date>
  <completion_date type="Actual">July 23, 2020</completion_date>
  <primary_completion_date type="Actual">July 23, 2020</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>Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment</measure>
    <time_frame>Up to Week 104</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants</measure>
    <time_frame>Up to Week 104</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Mean DAS28-ESR Score</measure>
    <time_frame>Baseline up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Continuation of Tocilizumab</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Retention Time of Tocilizumab</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment</measure>
    <time_frame>From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Low Disease Activity Defined by DAS28-ESR</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Low Disease Activity Defined by CDAI</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Mean CDAI Score</measure>
    <time_frame>Baseline up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response</measure>
    <time_frame>At Month 3 and Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Dose Used for Concomitant GCs</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Dose Reduction for Concomitant GCs</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction Visual Analogue Scale (VAS)</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment User-Friendliness VAS</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Treatment Adherence</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to Follow-up Treatment in Case of Switch from Tocilizumab</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events During Follow-up Treatment</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hannover Functional Ability Questionnaire (FFbH) Score</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Type of Physical Exercise</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Frequency of Physical Exercise</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Duration of Physical Exercise</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue-VAS</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance-VAS</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI) Questionnaire</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Questionnaire</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)</measure>
    <time_frame>Up to Week 104</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1454</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Participants with Rheumatoid Arthritis</arm_group_label>
    <description>Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants with active rheumatoid arthritis who are prescribed subcutaneous&#xD;
        tocilizumab treatment by their physician prior to and independent of the inclusion of the&#xD;
        participant into the study. Participant can be enrolled into the study at maximum 1 month&#xD;
        after first tocilizumab administration if baseline and disease characteristics data are&#xD;
        available.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have not yet been treated with tocilizumab&#xD;
&#xD;
          -  Participants who have received the first injection with tocilizumab maximum 1 month&#xD;
             before inclusion in the study and the necessary baseline data and disease&#xD;
             characteristics are present&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who at the time of the study inclusion are participating in a different&#xD;
             interventional study on rheumatoid arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)</name>
      <address>
        <city>Frankfurt</city>
        <zip>60528</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- 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/NCT02251860
org study id: ML29087
nct id: NCT02251860
lead sponsor: 
collaborator: 
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to
      evaluate the long-term effectiveness and tolerability of subcutaneously administered
      tocilizumab in participants with rheumatoid arthritis in daily clinical practice.
      Participants will be followed over an observation period of up to 2 years after the initial
      injection.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment
time frame: Up to Week 104
measure: Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants
time frame: Up to Week 104
measure: Change from Baseline in Mean DAS28-ESR Score
time frame: Baseline up to Week 104
measure: Percentage of Participants with Continuation of Tocilizumab
time frame: Up to Week 104
measure: Mean Retention Time of Tocilizumab
time frame: Up to Week 104
measure: Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment
time frame: From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)
measure: Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)
time frame: Up to Week 104
measure: Percentage of Participants with Low Disease Activity Defined by DAS28-ESR
time frame: Up to Week 104
measure: Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)
time frame: Up to Week 104
measure: Percentage of Participants with Low Disease Activity Defined by CDAI
time frame: Up to Week 104
measure: Change from Baseline in Mean CDAI Score
time frame: Baseline up to Week 104
measure: Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response
time frame: At Month 3 and Month 6
measure: Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)
time frame: Up to Week 104
measure: Mean Dose Used for Concomitant GCs
time frame: Up to Week 104
measure: Percentage of Participants with Dose Reduction for Concomitant GCs
time frame: Up to Week 104
measure: Treatment Satisfaction Visual Analogue Scale (VAS)
time frame: Up to Week 104
measure: Treatment User-Friendliness VAS
time frame: Up to Week 104
measure: Percentage of Participants with Treatment Adherence
time frame: Up to Week 104
measure: Response to Follow-up Treatment in Case of Switch from Tocilizumab
time frame: Up to Week 104
measure: Percentage of Participants with Adverse Events During Follow-up Treatment
time frame: Up to Week 104
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
time frame: Up to Week 104
measure: Hannover Functional Ability Questionnaire (FFbH) Score
time frame: Up to Week 104
measure: Percentage of Participants by Type of Physical Exercise
time frame: Up to Week 104
measure: Percentage of Participants by Frequency of Physical Exercise
time frame: Up to Week 104
measure: Percentage of Participants by Duration of Physical Exercise
time frame: Up to Week 104
measure: Fatigue-VAS
time frame: Up to Week 104
measure: Sleep Disturbance-VAS
time frame: Up to Week 104
measure: State-Trait Anxiety Inventory (STAI) Questionnaire
time frame: Up to Week 104
measure: Beck Depression Inventory (BDI) Questionnaire
time frame: Up to Week 104
measure: Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)
time frame: Up to Week 104
arm group label: Participants with Rheumatoid Arthritis
description: Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid