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Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Last updated on November 16, 2019

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Study Location
Rheumatology Associates P.C.
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

- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
swollen joints

- Active plaque psoriasis at screening

- Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

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

- Non-plaque forms of psoriasis (with exception of nail psoriasis)

- History of autoimmune rheumatic disease other than PsA; also prior history of or
current, rheumatic inflammatory disease other than PsA

NCT01882439
Pfizer
Completed
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

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Descriptive Information
Brief Title  ICMJE Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
Brief SummaryTo examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: Tofacitinib
    tablets, 5 mg BID x 6 months
  • Drug: Tofacitinib
    tablets, 10 mg BID x 6 months
  • Other: Placebo
    tablets, to match tofacitinib 5 mg BID x 3 months
  • Drug: Tofacitinib
    tablets, 5 mg BID x 3 months
  • Other: Placebo
    tablets, to match tofacitinib 10 mg BID x 3 months
  • Drug: Tofacitinib
    tablets, 10 mg BID x 3 months
Study Arms  ICMJE
  • Experimental: Treatment Sequence A
    Tofacitinib 5 mg BID for 6 months
    Intervention: Drug: Tofacitinib
  • Experimental: Treatment Sequence B
    Tofacitinib 10 mg BID for 6 months
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Treatment Sequence C
    Placebo for 3 months then tofacitinib 5 mg BID for 3 months
    Interventions:
    • Other: Placebo
    • Drug: Tofacitinib
  • Placebo Comparator: Treatment Sequence D
    Placebo for 3 months then tofacitinib 10 mg BID for 3 months
    Interventions:
    • Other: Placebo
    • Drug: Tofacitinib
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: September 8, 2017)
395
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2013)
390
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion DateApril 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening
  • Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion Criteria:

  • Non-plaque forms of psoriasis (with exception of nail psoriasis)
  • History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
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,   Czechia,   France,   Germany,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location CountriesCanada,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01882439
Other Study ID Numbers  ICMJE A3921125
2013-001368-46 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2017

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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