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

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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.


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
Rockland, Massachusetts 02370
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Rockland, MA
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Canada, 05251
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Canada,
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