Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, 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

NCT00603512

A3921039

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

Enrollment: 140 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active rheumatoid arthritis
• Inadequate response to stably dosed methotrexate

Exclusion criteria

• Current therapy with any DMARD or biologic other than methotrexate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 5 patient groups, including a placebo group

CP-690,550, 0mg

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

CP-690,550, 1mg

Experimental group

Treatment:

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

CP-690,550, 5mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550