A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID: NCT00430495
Run by: EMD Serono
People needed: 256
Starts: 2006-12-01
Expected to finish: 2009-09-01
Last updated by the study team: 2016-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

EMD Serono — Rockland, Massachusetts, United States
Merck/Serono — Canada, Canada

Full record on ClinicalTrials.gov

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