Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

May 31, 2007

Study Completion Date

July 31, 2012

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Abatacept or Placebo (both as IV & SC Solution)

Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).

DRUG

Abatacept or Placebo (both as IV & SC Solution)

Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).

DRUG

Abatacept or Placebo (both as IV & SC solution)

Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).

DRUG

Abatacept or Placebo (both as IV & SC solution)

Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).

DRUG

Abatacept or Placebo (both as IV & SC solution)

Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).

DRUG

Abatacept

Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly

Trial Locations (5)

28210

The Arthritis Clinic & Carolina Bone & Joint, Charlotte

30322

Winship Cancer Institute, Emory University, Atlanta

32806

Orlando Clinical Research Center, Orlando

55404

Davita Clinical Research, Minneapolis

70119

New Orleans Center For Clinical Research, New Orleans

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT00254293 - Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA) | Biotech Hunter | Biotech Hunter