Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413699

2006-005035-19 (EudraCT Number)

A3921024

Details and patient eligibility

About

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Enrollment: 4,488 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Vaccine sub-study visit

• Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

Exclusion criteria

• Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Vaccine sub-study visit

1. Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
2. Received any vaccine within 1 month prior to randomization in this study
3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,488 participants in 2 patient groups

Open-Label Active Treatment Enrolled from Phase 2

Experimental group

Description:

Patients enrolling from Phase 2 studies

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Open-Label Active Treatment Enrolled from Phase 3

Experimental group

Description:

Patients enrolling from Phase 3 studies

Treatment:

Drug: CP-690,550

Drug: CP-690,550