Phase 2
Completed N=256
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
Source: ClinicalTrials.gov NCT00430495 ↗Enrolled (actual)
256
Serious AEs
9.8%
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 — 29.0; 30.3; 27.4; 39.1 percentage of participants
Summary
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.
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 |
29.0; 30.3; 27.4; 39.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 |
6.5; 13.6; 11.3; 10.9 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26 |
0.0; 6.1; 4.8; 0.0 | — |
| SECONDARY Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26 |
9.7; 10.6; 9.7; 12.5 | — |
| SECONDARY Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26 |
1.6; 6.1; 4.8; 4.7 | — |
| SECONDARY Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26 |
47.4; 48.8; 55.9; 37.5 | — |
| SECONDARY Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26 |
41.9; 31.8; 35.5; 53.1 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
41; 49; 42; 46; 3; 9 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00430495). 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.