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

NCT00413699

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
Official Title  ICMJE A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis
Brief 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Open-Label Active Treatment Enrolled from Phase 2
    Patients enrolling from Phase 2 studies
    Intervention: Drug: CP-690,550
  • Experimental: Open-Label Active Treatment Enrolled from Phase 3
    Patients enrolling from Phase 3 studies
    Intervention: Drug: CP-690,550
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
4488
Original Enrollment  ICMJE
 (submitted: December 18, 2006)
560
Actual Study Completion Date  ICMJE October 26, 2017
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Costa Rica,   Croatia,   Czechia,   Denmark,   Dominican Republic,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   United States Minor Outlying Islands
 
Administrative Information
NCT Number  ICMJE NCT00413699
Other Study ID Numbers  ICMJE A3921024
2006-005035-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP