Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
NCT ID: NCT00664521
Last Updated: 2016-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2008-03-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Rituximab
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Atacicept
Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.
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.
Rituximab
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.
Interventions
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Rituximab
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Atacicept
Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.
Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.
Eligibility Criteria
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Inclusion Criteria
* Greater than and equal to (\>=) 18 years of age at the time of Informed Consent
* Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 12 months
* Subjects must have active disease defined by DAS28 \>3.2
* Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab
* Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (SD1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1
Exclusion Criteria
* Inflammatory joint disease other than rheumatoid arthritis
* Any contraindication to rituximab as per national label
* Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen \>25 mg/week
* Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
* Prednisone dose regimen \>10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
* Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
* Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)
* Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
* Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
* Breastfeeding or pregnancy
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Locations
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Research Site
Nice, , France
Research Site
Paris, , France
Research Site
Strasbourg, , France
Research Site
Amsterdam, , Netherlands
Research Site
Malmo, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Newcastle, , United Kingdom
Research Site
Norwich, , United Kingdom
Countries
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References
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van Vollenhoven RF, Wax S, Li Y, Tak PP. Safety and efficacy of atacicept in combination with rituximab for reducing the signs and symptoms of rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled pilot trial. Arthritis Rheumatol. 2015 Nov;67(11):2828-36. doi: 10.1002/art.39262.
Other Identifiers
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28155
Identifier Type: -
Identifier Source: org_study_id