Phase 3
Completed N=108
Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00989235 ↗Enrolled (actual)
108
Serious AEs
6.9%
Results posted
Jun 2011
Primary outcomePrimary: Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse) — 5.17; 2.00; 8.65; 4.00 Percentage of Events
Summary
The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 [DAS 28]-erythrocyte sedimentation rate [ESR] < 2.6) at Day 701 of study IM101023.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse) |
5.17; 2.00; 8.65; 4.00; 10.41; 12.35 | — |
| SECONDARY Number of Participants Experiencing Disease Relapse |
18; 17 | — |
| SECONDARY Mean Time-Matched Baseline DAS28 CRP Scores |
2.09; 2.05; 2.06; 2.06; 2.10; 2.09 | — |
| SECONDARY Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment |
0.24; 0.06; 0.05; 0.14; 0.13; 0.21 | — |
| SECONDARY Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status) |
22.4; 22.0 | — |
| SECONDARY Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment |
3.4; 12.0 | — |
| SECONDARY Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids |
0; 0 | — |
| SECONDARY Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment |
6.9; 8.0 | — |
| SECONDARY Percentage of Participants Who Modified Therapy During Double-Blind Treatment |
10.3; 18.0 | — |
| SECONDARY Percentage of Participants Who Lost Remission Status |
53.4; 64.0 | — |
| SECONDARY Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment |
22992.0; 21713.5; 22213.0; 23620.7; 24919.5; 11922.1 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment |
0; 2.0; 5.2; 6.0; 1.7; 0 | — |
| SECONDARY Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment |
37.9; 26.0; 5.2; 12.0; 5.2; 6.0 | — |
| SECONDARY Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment |
0; 0 | — |
| SECONDARY Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity |
0; 2.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity |
6.9; 4.0; 1.7; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity |
0; 4.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Clinically Significant Changes in Vital Signs and Physical Findings |
— | — |
| SECONDARY Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment |
4; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed the main study, are willing to participate and have a DAS 28 ESR score of < 2.6 on Day 701 of the main study
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00989235). 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.