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| Sponsored by: |
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 |
| MedlinePlus related topics: | Rheumatoid Arthritis |
| ChemIDplus related topics: | Rituximab |
| 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 | |||||
| EMD Serono |
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 |
| 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 |
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