Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 87
Healthy volunteers: no

Brief summary:
The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: Long Term

Interventions: intervention 1: Abatacept or Placebo (both as IV & SC Solution) intervention 2: Abatacept or Placebo (both as IV & SC Solution) intervention 3: Abatacept or Placebo (both as IV & SC solution) intervention 4: Abatacept or Placebo (both as IV & SC solution) intervention 5: Abatacept or Placebo (both as IV & SC solution) intervention 6: Abatacept
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: 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). intervention 4: 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). intervention 5: 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). intervention 6: Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly

Protocol document: