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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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