A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550446

A3921035

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Enrollment: 386 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have active rheumatoid arthritis
• Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
• Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion criteria

• Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
• Subjects who previously received adalimumab (Humira®) therapy for any reason.
• Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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386 participants in 7 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Adalimumab

2

Experimental group

Treatment:

Drug: CP-690-550

3

Experimental group

Treatment:

Drug: CP-690-550

4

Experimental group

Treatment:

Drug: CP-690-550

5

Experimental group

Treatment:

Drug: CP-690,550

6

Experimental group

Treatment:

Drug: CP-690,550

7

Placebo Comparator group

Treatment:

Drug: Placebo