Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

Pfizer

Status and phase

Completed

Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Drug: CP-690,550

Other: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413660

A3921025

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

Enrollment

509 patients

Sex

All

Ages

18+ 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

509 participants in 7 patient groups, including a placebo group

CP 690,550 1 mg BID

Experimental group

Treatment:

Drug: CP-690,550

CP 690,550 10 mg BID

Experimental group

Treatment:

Drug: CP-690,550

CP 690,550 15 mg

Experimental group

Treatment:

Drug: CP-690,550

CP 690,550 3 mg BID

Experimental group

Treatment:

Drug: CP-690,550

CP 690,550 5 mg BID

Experimental group

Treatment:

Drug: CP-690,550

CP-690,550 20 mg QD

Experimental group

Treatment:

Drug: CP-690,550

Placebo

Placebo Comparator group

Description:

Dummy tablets

Treatment:

Other: placebo

Trial contacts and locations

82

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