Conditions: Rheumatoid Arthritis
Keywords: Pharmacokinetics oral JAK inhibitor methotrexate (MTX) rheumatoid arthritis (RA)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.

Detailed description:

Arms:
arm 1: Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h

Interventions: intervention 1: CP-690,550 (tofacitinib) intervention 2: Methotrexate (MTX)
Intervention descriptions: intervention 1: CP-690,550 30 mg q12h for 5 days intervention 2: individual dose of methotrexate (stably dosed)

Protocol document: