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Long-Term Effectiveness And S...

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

Last Updated: 2018-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-05

Study Completion Date

2017-10-26

Brief Summary

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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

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-Label Active Treatment Enrolled from Phase 2

Patients enrolling from Phase 2 studies

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Open-Label Active Treatment Enrolled from Phase 3

Patients enrolling from Phase 3 studies

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Interventions

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CP-690,550

5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Intervention Type DRUG

CP-690,550

10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States

Site Status

Arthrocare, Arthritis Care & Research, PC

Gilbert, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Site Status

Radiant Research, Inc.

Scottsdale, Arizona, United States

Site Status

Catalina Pointe Clinical Research

Tucson, Arizona, United States

Site Status

CHI St. Vincent Medical Group Hot Springs

Hot Springs, Arkansas, United States

Site Status

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Site Status

Osborne Research Center, LLC

Little Rock, Arkansas, United States

Site Status

Little Rock Diagnostic Clinic, PA

Little Rock, Arkansas, United States

Site Status

Med Investigations, Inc.

Fair Oaks, California, United States

Site Status

Talbert Medical Group

Huntington Beach, California, United States

Site Status