A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847613

A3921044

Details and patient eligibility

About

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion criteria

• Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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800 participants in 4 patient groups, including a placebo group

Sequence 1

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Sequence 2

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Sequence 3

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: CP-690,550

Drug: CP-690,550

Sequence 4

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: CP-690,550

Drug: CP-690,550