Phase 2
Completed N=311
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
Source: ClinicalTrials.gov NCT00595413 ↗Enrolled (actual)
311
Serious AEs
5.1%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 — 46.1; 44.9; 57.7; 70.9 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 |
46.1; 44.9; 57.7; 70.9 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 |
14.5; 29.5; 33.3; 38.0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26 |
5.3; 12.8; 12.8; 17.7 | — |
| SECONDARY Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26 |
59.2; 64.1; 67.9; 81.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
38; 49; 49; 50; 2; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00595413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.