Phase 3
Completed N=113
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT00409838 ↗Enrolled (actual)
113
Serious AEs
4.5%
Results posted
Jan 2010
Primary outcomePrimary: Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20) — 65.5; 42.1 percentage of participants
Summary
The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20) |
65.5; 42.1 | — |
| PRIMARY Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs |
1; 41; 10; 8; 100; 45 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169 |
32.7; 15.8; 14.5; 7.0 | — |
| SECONDARY Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components |
81.1; 76.9; 66.0; 50.0; 49.1; 23.1 | — |
| SECONDARY Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR]) |
-2.12; -1.21; -2.22; -1.15; -2.97; -3.13 | — |
| SECONDARY Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
-0.53; -0.24; -0.58; -0.37; -0.58; -0.36 | — |
| SECONDARY Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains |
6.52; 2.16; 8.18; 4.36 | — |
| SECONDARY Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period |
0; 1.8; 3.6; 5.3; 0; 1.8 | — |
| SECONDARY Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half) |
1.385; 1.193; 1.325; 183.583; 172.451; 180.078 | — |
| SECONDARY Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax) |
241.972; 312.591; 264.204 | — |
| SECONDARY Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC) |
38940.063; 48283.479; 41881.508 | — |
| SECONDARY Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT) |
0.269; 0.240; 0.260 | — |
| SECONDARY Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS) |
0.064; 0.055; 0.061 | — |
| SECONDARY Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept |
37.76; 52.19; 42.30; 19.96; 24.42; 21.31 | — |
| SECONDARY Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169 |
0; 0 | — |
| SECONDARY Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169 |
-30.0; -4.44 | — |
| SECONDARY Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169 |
-54.1; -12.1 | — |
| SECONDARY LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples |
14; 9; 11 | — |
| SECONDARY Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time |
13.2; 11.5; 1.9; 3.8; 0; 0 | — |
| SECONDARY Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI) |
77.4; 60.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
-0.76; -0.53 | — |
| SECONDARY Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries |
10.34; 8.48; 7.93; 7.73 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission |
35.8; 13.5; 61.3; 68.6; 24.5; 9.6 | — |
| SECONDARY Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores |
-22.84; -14.07; -29.74; -29.20; -20.99; -13.49 | — |
| SECONDARY Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission |
35.8; 13.5; 51.9; 35.3; 62.5; 56.0 | — |
| SECONDARY Change From Baseline in Levels of C-reactive Protein (CRP) |
-1.85; -0.58; -1.87; -1.23; -1.73; -1.62 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate |
-30.60; -7.12; -28.43; -15.14; -27.30; -20.27 | — |
Eligibility Criteria
Key Inclusion Criteria
- Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
- Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
- Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses
Key Exclusion Criteria
- Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment
Data sourced from ClinicalTrials.gov (NCT00409838). 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.