A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: CP-690,550 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484561

A3921152

Details and patient eligibility

About

The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the seven criteria.
• The patient must have active disease at both Screening and predose on Day 1 of Period 1.
• Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance.

Exclusion criteria

• Pregnant or lactating women
• Serious medical conditions that would make treatment with CP-690,550 potentially unsafe.
• A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular, a history of allergy to iodine, povidone-iodine, iohexol or other iodinated contrast media.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 2 patient groups, including a placebo group

Sequence 1

Active Comparator group

Treatment:

Drug: CP-690,550 or Placebo

Sequence 2

Placebo Comparator group

Treatment:

Drug: Placebo