Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Abatacept in Korean Subjects With Active Rheumatoid Arthritis
NCT00409838Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2007
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- Bristol Myers Squibb
- Modality
- Fc-Fusion Proteins
- Drugs
- abatacept
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, double-blind trial of abatacept in rheumatoid arthritis (RA) (3 arms), sponsored by Bristol Myers Squibb. Primary endpoints: Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement at Day 169 and Long-term Extension (LTE) Period: Deaths, SAEs, AEs, Discontinuations. Started Apr 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Abatacept + MTX
Abatacept IV + Methotrexate
Placebo + MTX
Placebo IV + Methotrexate
Abatacept + MTX (Extension)
Open-label Abatacept + Methotrexate
03
Who it enrols
Korean patients with active RA for >1 year and inadequate response to methotrexate (>=15mg/week for >=3 months).
04
Endpoints
Primary
Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement
Long-term Extension (LTE) Period: Deaths, SAEs, AEs, Discontinuations
Secondary
Percentage of Participants With ACR50 and ACR70 Response
Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in ACR Core Components
Change From Baseline in Disease Activity Scores (DAS) Based on CRP or ESR
Change From Baseline in Health Assessment Questionnaire Disability Index Score
Change From Baseline in Short-Form 36 Health Survey Questionnaire Domains
Percentage of Participants Experiencing Deaths, SAEs, AEs, and Discontinuations
Abatacept Pharmacokinetic Parameters (Tmax, T-Half, Cmax, AUC, CLT, VSS, Cmin)
Immunogenicity of Abatacept
Beyond the preview
Go deeper on NCT00409838.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00409838.