At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 20 enrolled
Drug / intervention
rituximab [MabThera/Rituxan] +1 moredrug
Likely dose
rituximab [MabThera/Rituxan] 1gfrom 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.
An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
In Brief
A Phase 4 clinical trial evaluating rituximab [MabThera/Rituxan] and Methotrexate for Rheumatoid Arthritis. Completed, enrolled 20 participants across 3 sites.
Detailed Summary
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesHungary
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionOct 2009
TodayJul 2026
First PostedJan 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.5 years ago
Interventions
rituximab [MabThera/Rituxan]drug
1g iv on days 1 and 15
Methotrexatedrug
10-25mg po/week