Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2007 |
End Date: | October 2009 |
A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
The primary objective of this study is to evaluate the efficacy of atacicept compared to
placebo in the treatment of signs and symptoms in a subject population with active
rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous
exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.
placebo in the treatment of signs and symptoms in a subject population with active
rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous
exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.
Inclusion Criteria:
- Male or female subjects greater than or equal to (>=) 18 years of age at the time of
informed consent who have RA satisfying American College of Rheumatology (ACR)
criteria with a disease history of at least 6 months
- 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
- Other protocol-defined inclusion criteria could apply
Exclusion Criteria:
- Inflammatory joint disease other than RA
- 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
- Other protocol-defined exclusion criteria could apply
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