CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 193 enrolled
Drug / intervention
rituximab [MabThera/Rituxan]drug
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.

Search/NCT00502840
NCT00502840Phase 3Completed
CompareCT.gov

An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).

Hoffmann-La Roche·interventional·Posted Jul 18, 2007·Updated Aug 18, 2017

In Brief

A Phase 3 clinical trial evaluating rituximab [MabThera/Rituxan] for Rheumatoid Arthritis. Completed, enrolled 193 participants across 51 sites.

Detailed Summary

This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 \>2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2007
Enrollment StartJul 23, 2007
Primary CompletionSep 20, 2011
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 19.0 years ago

Interventions

rituximab [MabThera/Rituxan]drug

1g iv on days 1 and 15