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

NCT00664521 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-12-30

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • France
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664521 on ClinicalTrials.gov