Phase 3
Completed N=646
Abatacept Versus Adalimumab Head-to-Head
Source: ClinicalTrials.gov NCT00929864 ↗Enrolled (actual)
646
Serious AEs
15.0%
Results posted
Jan 2014
Primary outcomePrimary: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population — 64.8; 63.4 percentage of participants
Summary
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population |
64.8; 63.4 | — |
| SECONDARY Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population |
3.8; 9.1 | 0.006 sig |
| SECONDARY Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population |
2.24; 6.38 | — |
| SECONDARY Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population |
87.8; 88.6; 84.8; 83.8 | — |
| SECONDARY Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population |
11.06; 10.26; 2.32; 2.99; 0.33; 0.33 | — |
| SECONDARY Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population |
13.8; 16.5; 3.8; 5.8; 0.6; 1.5 | — |
| SECONDARY Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population |
5.2; 13.3; 0.3; 9.9; 6.3; 14.7 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
- Methotrexate failure
- Naive to RA biologics
- ≤5 years duration of disease
- Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
- Willingness to self-inject subcutaneous (SC) drug
Exclusion Criteria
- Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
- History of active or chronic hepatitis
- Cancer in the last 5 years
- History of severe chronic or recurrent bacterial or viral infections
- Risk of tuberculosis
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease
Data sourced from ClinicalTrials.gov (NCT00929864). 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.