Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)

Outcome Description:

An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).

Outcome Time Frame:

Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Korea: Food and Drug Administration

Study ID:

IM101-023 LT (Sub study)

NCT ID:

NCT00989235

Start Date:

April 2007

Completion Date:

October 2009

Related Keywords:

• Rheumatoid Arthritis
• NOS
• Arthritis
• Arthritis, Rheumatoid