A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2006 |
End Date: | September 2009 |
A Randomized, Double-blind, Placebo-controlled, Multicentre, Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy
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 failed a three month therapeutic trial with a tumor necrosis
factor alpha (TNFa) antagonist due to lack of efficacy.
dose-finding trial of the safety and efficacy of atacicept in subjects with active
rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis
factor alpha (TNFa) antagonist due to lack of efficacy.
Inclusion Criteria:
1. Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR)
diagnostic criteria with a disease history of at least one year
2. Male or female greater than or equal to (>=)18-years of age at time of informed
consent
3. 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)
4. Failure of at least one TNFa antagonist therapy (previously or at the time of
screening) as specified in the protocol
5. Other protocol defined inclusion criteria could apply
Exclusion Criteria:
1. 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
2. Treatment with biologics aiming at B cell modulation such as rituximab or belimumab
within 2 years before study Day 1
3. Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab
within 3 months before study Day 1
4. 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
5. 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)
6. Other protocol defined exclusion criteria could apply
We found this trial at
2
sites
Click here to add this to my saved trials
