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

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT00664521
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2008
Status verified
Nov 2016
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab Plus Atacicept
    Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
  • Placebo Comparator: Rituximab Plus Placebo
    Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 64 ]

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