Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT02322801
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
Inclusion Criteria
- Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha and who started rituximab (RTX) treatment in the 12 months before site initiation and were still under treatment when enrollment starts
Read More
Exclusion Criteria
- Patients with serious infections
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment Up to 31 months (24 months each patient)
- Secondary Outcome Measures
Name Time Method Percent of patients with at least one severe adverse event (SAE) Up to 31 months (24 months each patient) Percent of patients who discontinued therapy with RTX Up to 31 months (24 months each patient) Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs Up to 31 months (24 months each patient) Time to response and duration of response to RTX Up to 31 months (24 months each patient) Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline Up to 31 months (24 months each patient) Time to "re-treatment" with RTX Up to 31 months (24 months each patient)