CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 505 enrolled
Drug / intervention
Rituximabdrug
Likely dose
Not stated in 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/NCT01641952
NCT01641952N/ACompleted
CompareCT.gov

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Hoffmann-La Roche·observational·Posted Jul 17, 2012·Updated Aug 17, 2016

In Brief

An observational study evaluating Rituximab for Rheumatoid Arthritis. Completed, enrolled 505 participants across 1 site.

Detailed Summary

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesRomania
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.0 years ago

Interventions

Rituximabdrug

Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.