At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
CP-690,550 (tofacitinib) +1 moredrug
Likely dose
CP-690,550 (tofacitinib) 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects
In Brief
A Phase 1 clinical trial evaluating CP-690,550 (tofacitinib) and Methotrexate (MTX) for Rheumatoid Arthritis. Completed, enrolled 12 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
Primary CompletionJun 2006
First PostedDec 2012
TodayJul 2026
First PostedDec 7, 2012
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.6 years ago
Interventions
CP-690,550 (tofacitinib)drug
CP-690,550 30 mg q12h for 5 days
Methotrexate (MTX)drug
individual dose of methotrexate (stably dosed)