CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
rituximabdrug
Likely dose
rituximab 1000 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.

Search/NCT01272908
NCT01272908Phase 3Completed
CompareCT.gov

Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

Hoffmann-La Roche·interventional·Posted Jan 10, 2011·Updated Aug 15, 2017

In Brief

A Phase 3 clinical trial evaluating rituximab for Rheumatoid Arthritis. Completed, enrolled 120 participants across 41 sites in 2 countries.

Detailed Summary

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCanada, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2011
Enrollment StartJul 18, 2006
Primary CompletionMar 12, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.5 years ago

Interventions

rituximabdrug

1000 mg intravenously on Days 1 and 15