Co-Administration Of Methotrexate And CP-690,550

Pfizer12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

CP-690,550 (tofacitinib)DRUG

CP-690,550 30 mg q12h for 5 days

Methotrexate (MTX)DRUG

individual dose of methotrexate (stably dosed)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (4)

Pfizer Investigational Site

Daytona Beach, Florida, United States

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Pfizer Investigational Site

Miramar, Florida, United States

Pfizer Investigational Site

Dallas, Texas, United States

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550

AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7

Maximum Observed Plasma Concentration (Cmax) for CP-690,550

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7

Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7

Secondary Outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7

Plasma Decay Half-Life (t1/2) for CP-690,550

Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half.

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7

Apparent Oral Clearance (CL/F) for CP-690,550

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Data from ClinicalTrials.gov

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