At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 246 enrolled
Drug / intervention
Methotrexate +1 moredrug
Likely dose
Methotrexate 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)
In Brief
A Phase 3 clinical trial evaluating Methotrexate and rituximab [MabThera/Rituxan] for Rheumatoid Arthritis. Completed, enrolled 246 participants across 49 sites in 10 countries.
Detailed Summary
This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Mexico, Peru, Uruguay, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedJul 2007
Primary CompletionDec 2008
TodayJul 2026
First PostedJul 18, 2007
Enrollment StartFeb 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.0 years ago
Interventions
Methotrexatedrug
\>=15 mg po/week
rituximab [MabThera/Rituxan]drug
1g iv on days 1 and 15