CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
rituximab [MabThera/Rituxan] +2 moredrug
Likely dose
rituximab [MabThera/Rituxan] 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/NCT02006706
NCT02006706Phase 3Completed
CompareCT.gov

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure

Hoffmann-La Roche·interventional·Posted Dec 10, 2013·Updated Aug 21, 2017

In Brief

A Phase 3 clinical trial evaluating rituximab [MabThera/Rituxan], methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 15 participants across 3 sites.

Detailed Summary

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2013
Enrollment StartAug 10, 2006
Primary CompletionNov 23, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.6 years ago

Interventions

rituximab [MabThera/Rituxan]drug

1000 mg iv Days 1 and 15

methotrexatedrug

10 - 25 mg/week

methylprednisolonedrug

iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion