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| Sponsor: | EMD Serono |
|---|---|
| Information provided by: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00664521 |
Purpose
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
|
| 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
|
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| 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: | March 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00664521 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency; 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 Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid |
Rheumatic Diseases Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Antirheumatic Agents |