CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Rituximab +2 morebiological
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/NCT00664521
NCT00664521Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

Merck KGaA, Darmstadt, Germany·interventional·Posted Apr 23, 2008·Updated Dec 30, 2016

In Brief

A Phase 2 clinical trial evaluating Rituximab, Atacicept, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 27 participants across 8 sites in 4 countries.

Detailed Summary

The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesFrance, Netherlands, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 23, 2008
Enrollment StartMar 1, 2008
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.2 years ago

Interventions

Rituximabbiological

Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.

Ataciceptdrug

Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.

Placebo matched to ataciceptdrug

Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.