Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
NCT01877668
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- Males or females, aged >= 18 years at time of consent.
- Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
- Meet the Classification Criteria of PsA (CASPAR) at time of screening
- Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
- Must not have taken a biologic Tumour Necrosis Factor Inhibitor
- Must have 3 or more swollen joints AND 3 or more tender joints
- Must have active psoriasis skin lesions
- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the
exception of nail psoriasis which is allowed
- Pregnant or breast feeding, females of child-bearing potential not using highly
effective contraception
- New York Heart Association Class III and IV congestive heart failure
- History of hypersensitivity or infusion reaction to biologic agents
- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
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Descriptive Information | |||||
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Brief Title ICMJE | Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study | ||||
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) Or Adalimumab In Subjects With Active Psoriatic Arthritis | ||||
Brief Summary | This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE | Psoriatic Arthritis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | 422 | ||||
Original Estimated Enrollment ICMJE | 400 | ||||
Actual Study Completion Date ICMJE | December 18, 2015 | ||||
Actual Primary Completion Date | December 18, 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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, Bulgaria, Canada, Czechia, France, Germany, Hungary, Mexico, Poland, Russian Federation, Slovakia, Spain, Taiwan, United Kingdom, United States | ||||
Removed Location Countries | Czech Republic | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01877668 | ||||
Other Study ID Numbers ICMJE | A3921091 2011-003668-55 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | June 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |