Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
NCT ID: NCT00595413
Last Updated: 2016-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
311 participants
INTERVENTIONAL
2007-09-30
2009-10-31
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
DOUBLE
Study Groups
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Atacicept 150 mg with loading dose
Atacicept: with loading dose
Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Atacicept 150 mg without loading dose
Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.
Adalimumab
Adalimumab
Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
Placebo
Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Interventions
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Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept: with loading dose
Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.
Adalimumab
Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have active disease, defined by \>=8 swollen joints (out of 66), \>=8 tender joints (out of 68) and CRP \>=10 milligram per liter (mg/L) and/or erythrocyte sedimentation rate (ESR) \>=28 millimeter per hour (mm/hr), despite treatment with MTX at a dose of \>=15 milligram per week (mg/week) for greater than (\>) 3 months
Exclusion Criteria
* Previous or concurrent treatment with any approved or investigational biological compound for RA, including but not restricted to any anti-TNFalpha agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab
* Treatment with disease-modifying anti-rheumatic drug (DMARDs) other than MTX
* Participation in any interventional clinical trial within 1 month before study Day 1
* MTX dose \>25 mg/week, prednisone dose \>10 mg/day (or equivalent), or change in steroid or non-steroidal anti-inflammatory drug (NSAID) dosing regimen within 28 days before study Day 1
* Immunization with live vaccine or immunoglobulin (Ig) treatment within 28 days before study Day 1 or need for such treatment during the study (including follow-up)
* Any history or presence of active or latent tuberculosis, major infection requiring hospitalization or intravenous anti-infectives within 28 days before study Day 1
* Other major concurrent illness or organ dysfunction as specified in the protocol
* Serum IgG below 6 gram per liter (g/L)
* Known hypersensitivity to atacicept or to any of the components of the formulated atacicept
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany
Locations
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Please Contact US Medical Information
Rockland, Massachusetts, United States
Please contact the Merck KGaA Communication Center
Darmstadt, , Germany
Countries
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References
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van Vollenhoven RF, Kinnman N, Vincent E, Wax S, Bathon J. Atacicept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2011 Jul;63(7):1782-92. doi: 10.1002/art.30372.
Related Links
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The European League Against Rheumatism (EULAR)
Other Identifiers
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2007-002536-29
Identifier Type: -
Identifier Source: secondary_id
27905
Identifier Type: -
Identifier Source: org_study_id
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