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

Last updated on March 28, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
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.

NCT00413699
Pfizer
Completed
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

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Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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.
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4553
November 10, 2017
November 30, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic,   United States Minor Outlying Islands
 
NCT00413699
A3921024
2006-005035-19 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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