NCT00664521

Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Rituximab	Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
DRUG	Atacicept	Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.
DRUG	Placebo matched to atacicept	Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-04-23
• Last updated: 2016-12-30
• Results posted: 2016-12-30

Locations

8 sites across 4 countries: France, Netherlands, Sweden, United Kingdom