Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

Pfizer

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687193

A3921040

Details and patient eligibility

About

To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.

Enrollment: 318 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.

Exclusion criteria

• Current therapy with any DMARD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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318 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CP-690,550, 10mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

CP-690,550, 15mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

CP-690,550, 1mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

CP-690,550, 3mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

CP-690,550, 5mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550