An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)
MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice
1 other identifier
observational
1,240
1 country
1
Brief Summary
This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 6, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 2, 2016
November 1, 2016
5.7 years
September 6, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)
from baseline to Week 92
Secondary Outcomes (1)
Safety: Incidence of adverse events
4 years
Study Arms (1)
Cohort
Eligibility Criteria
Patients with an inadequate response to prior anti-TNF therapy
You may qualify if:
- Adult patients, \>/= 18 years of age
- Active Rheumatoid Arthritis
- Inadequate response to anti-TNF
- Eligible for MabThera/Rituxan therapy according to physician's decision
You may not qualify if:
- According to Summary of Product Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Bucharest, 020983, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2010
First Posted
September 8, 2010
Study Start
February 1, 2010
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11