Co-Administration Of Methotrexate And CP-690,550

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CP-690,550 (tofacitinib) 30 mg q12h

Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h

Group Type EXPERIMENTAL

CP-690,550 (tofacitinib)

Intervention Type DRUG

CP-690,550 30 mg q12h for 5 days

Methotrexate (MTX)

Intervention Type DRUG

individual dose of methotrexate (stably dosed)

Interventions

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CP-690,550 (tofacitinib)

CP-690,550 30 mg q12h for 5 days

Intervention Type DRUG

Methotrexate (MTX)

individual dose of methotrexate (stably dosed)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week, administered as a single dose \[SD\]) for a minimum of 4 doses (4 weeks)

Exclusion Criteria

* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L
* Evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
* Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) more than 1.2 times the upper limit of normal at the Screening visit, or a history of clinically significant elevated liver function tests (LFTs) while on current MTX dose or chronic liver disease, recent or active hepatitis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No