Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00413699

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

Official Title:

A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

Summary

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

Eligibility

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.

Disease(s) and\or Condition(s)

Arthritis, Rheumatoid

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: CP-690,550
    • Description: 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.
    • Arm Group Labels: Open-Label Active Treatment Enrolled from Phase 2
    • Type: DRUG
    • Name: CP-690,550
    • Description: 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.
    • Arm Group Labels: Open-Label Active Treatment Enrolled from Phase 3
Sponsor
  • Pfizer