A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359150

A3921129

Details and patient eligibility

About

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
• The subject must have active disease at both screening and baseline

Exclusion criteria

• History of any documented influenza or pneumococcal infection within the last 3 months.
• Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).
• If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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223 participants in 2 patient groups, including a placebo group

Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).

Experimental group

Description:

CP-690,550 will be administered for 4 weeks, vaccines will be administered at week 4. CP-690,550 will then continue for another 5 weeks at which point the immune response will be evaluated.

Treatment:

Drug: CP-690,550

Treatment Group 2:Placebo CP-690,550 (100 subjects).

Placebo Comparator group

Description:

Placebo will be administered for 4 weeks, vaccines will be administered at week 4. Placebo will then continue for another 5 weeks at which point the immune response will be evaluated.

Treatment:

Drug: placebo