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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Rheumatology Associates, PC
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic 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

- Previous participation in qualifying PsA study involving tofacitinib

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

- Time from End of Study visit of qualifying study is >3 months.

- Pregnant female, breastfeeding female or female of childbearing potential unwilling or
unable to use highly effective birth control for duration of study and one ovulatory
cycle thereafter.

Sub-study Inclusion Criteria:

- Subjects who have completed at least 24 months of treatment with tofacitinib in the
extension study

- Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

Sub-study Exclusion Criteria:

-Subjects who are receiving methotrexate by a route other than oral

NCT01976364
Pfizer
Completed
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

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Descriptive Information
Brief Title  ICMJE Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Official Title  ICMJE A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Brief Summary

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
The sub-study will be participant, care provider, investigator and outcomes assessor masked.

Primary Purpose: Treatment

Condition  ICMJE Arthritis, Psoriatic
Intervention  ICMJE
  • Drug: Tofacitinib
    Tofacitinib 5 mg tablet twice daily
  • Drug: Tofacitinib
    Tofactinib 10 mg tablet twice daily
  • Drug: Methotrexate
    Methotrexate 7.5-20 mg weekly
    Other Name: Sub-study
  • Drug: Placebo Methotrexate
    Placebo to match active methotrexate orally once a week
    Other Name: Sub-study
Study Arms  ICMJE Experimental: Tofacitinib
Interventions:
  • Drug: Tofacitinib
  • Drug: Tofacitinib
  • Drug: Methotrexate
  • Drug: Placebo Methotrexate
Publications *Not Provided


*   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: September 3, 2019)
873
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2013)
700
Actual Study Completion Date  ICMJE May 20, 2019
Actual Primary Completion DateMay 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previous participation in qualifying PsA study involving tofacitinib

Exclusion Criteria:

  • Time from End of Study visit of qualifying study is >3 months.
  • Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.

Sub-study Inclusion Criteria:

  • Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
  • Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

Sub-study Exclusion Criteria:

-Subjects who are receiving methotrexate by a route other than oral

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 Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Czechia,   Germany,   Hungary,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT01976364
Other Study ID Numbers  ICMJE A3921092
2011-002169-39 ( EudraCT Number )
OPAL BALANCE ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]

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