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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Last updated on April 19, 2018

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
Active, not recruiting
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

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Pfizer Clinical Trials Contact Center

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[email protected]

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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
A Long-term, Open-label Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis

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.

Not Provided
Interventional
Phase 3
Masking: None (Open Label)
Masking Description:
The sub-study will be participant, care provider, investigator and outcomes assessor masked.

Primary Purpose: Treatment

Arthritis, Psoriatic
  • 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
Experimental: Tofacitinib
Interventions:
  • Drug: Tofacitinib
  • Drug: Tofacitinib
  • Drug: Methotrexate
  • Drug: Placebo Methotrexate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
686
January 2, 2020
January 2, 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Czechia,   Germany,   Hungary,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT01976364
A3921092
2011-002169-39 ( EudraCT Number )
OPAL BALANCE ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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