Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960440

A3921032

Details and patient eligibility

About

This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

Enrollment: 399 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 who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

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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399 participants in 4 patient groups, including a placebo group

Sequence 1

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Sequence 2

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Sequence 3

Placebo Comparator group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: Placebo

Drug: CP-690,550

Drug: CP-690,550

Drug: Placebo

Sequence 4

Placebo Comparator group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: Placebo

Drug: CP-690,550

Drug: CP-690,550

Drug: Placebo