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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00664521 |
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 receiving re-treatment with rituximab.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Biological: Rituximab Biological: Atacicept / placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | 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. |
Estimated Enrollment: | 54 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Rituximab
Rituximab 1000 mg IV infusion, 2nd 1000 mg IV infusion given 2 weeks later, followed 28 days later by atacicept/placebo 150 mg/mL SC once weekly for 25 weeks
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2: Experimental |
Biological: Atacicept / placebo
Atacicept/placebo 150 mg/mL SC once weekly for 25 weeks, given in combination with rituximab 1000 mg IV infusion on study day 10, 2nd 1000 mg IV infusion given 2 weeks later
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have active disease defined by
Exclusion Criteria:
Contact: Carol Marsella, BSc (Hons) | +41-22-414-3918 | carol.marsella@merckserono.net |
Contact: Amanda Clark, RGN, BN, BASc | +41-22-414-3236 | amanda.clark@merckserono.net |
Finland | |
Research Site | Recruiting |
Helsinki, Finland | |
Contact: Local Medical Information 358-985-202-328 | |
Research Site | Recruiting |
Jyväskylä, Finland | |
Contact: Local Medical Information 358-985-202-328 | |
France | |
Research Site | Recruiting |
Paris, France | |
Contact: Local Medical Information 33-1476-12661 | |
Research Site | Recruiting |
Strasbourg, France | |
Contact: Local Medical Information 33-1476-12661 | |
Research Site | Recruiting |
Nice, France | |
Contact: Local Medical Information 33-1476-12661 | |
Netherlands | |
Research Site | Recruiting |
Amsterdam, Netherlands | |
Contact: Local Medical Information 317-030-25741 | |
Sweden | |
Research Site | Recruiting |
Stockholm, Sweden | |
Contact: Local Medical Information 468-562-44528 | |
Research Site | Recruiting |
Malmö, Sweden | |
Contact: Local Medical Information 468-562-44528 | |
United Kingdom | |
Research Site | Recruiting |
Norwich, United Kingdom | |
Contact: Local Medical Information 44-208-818-7232 | |
Research Site | Recruiting |
Newcastle, United Kingdom | |
Contact: Local Medical Information 44-208-818-7232 |
Responsible Party: | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany ( Carol Marsella, Clinical Trial Leader ) |
Study ID Numbers: | 28155 |
Study First Received: | April 21, 2008 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00664521 |
Health Authority: | Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Autoimmune Diseases Musculoskeletal Diseases Rituximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |