A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

PHASE3CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

December 31, 2011

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Abatacept

Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

DRUG

Methotrexate

Tablets, Oral, ≥ 15 mg, weekly, 6 months

DRUG

Placebo

IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

DRUG

Abatacept

Solution, intravenous, 10 mg/kg, every 28 days

DRUG

Methotrexate

Tablets, oral, 15 mg weekly to be adjusted according to patient condition

Trial Locations (7)

133-792

Local Institution, Seoul

431-070

Local Institution, Anyang

705-718

Local Institution, Daegu

302-799

Local Institution, Daejeon

110-744

Local Institution, Seoul

137-040

Local Institution, Seoul

138-736

Local Institution, Seoul

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT00409838 - A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Biotech Hunter | Biotech Hunter