Status:
COMPLETED
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had fail...
Eligibility Criteria
Inclusion
- Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic criteria with a disease history of at least one year
- Male or female greater than or equal to (\>=)18-years of age at time of informed consent
- Active RA as defined by:
- \>=8 swollen joints (66-joint count),
- \>=8 tender joints (68-joint count), and
- C-reactive protein (CRP) \>=10 milligram per liter (mg/L) (central laboratory) and/or erythrocyte sedimentation rate (ESR) \>= to 28 millimeter per hour (mm/h)
- Failure of at least one TNFa antagonist therapy (previously or at the time of screening) as specified in the protocol
- Other protocol defined inclusion criteria could apply
Exclusion
- Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
- Treatment with biologics aiming at B cell modulation such as rituximab or belimumab within 2 years before study Day 1
- Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab within 3 months before study Day 1
- Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab (Remicade) or adalimumab (Humira) within 60 days before study Day 1
- Participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study Day 1, whichever is longer)
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00430495
Start Date
December 1 2006
End Date
September 1 2009
Last Update
February 17 2016
Active Locations (2)
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1
EMD Serono
Rockland, Massachusetts, United States, 02370
2
Merck/Serono
Canada, Canada