Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT01976364
Phase
PHASE3
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Tofacitinib 5 mg tablet twice daily
  • Tofacitinib — DRUG
    Tofactinib 10 mg tablet twice daily
  • Methotrexate — DRUG
    Methotrexate 7.5-20 mg weekly
  • Placebo Methotrexate — DRUG
    Placebo to match active methotrexate orally once a week

Study Details

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.

Key Dates

Start date
Feb 17, 2014
Status verified
May 2020
Primary completion
May 20, 2019
Completion
May 20, 2019

Study Design

Enrollment
686 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib

Primary Outcome Measure

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) ]

Locations (43)

FacilityCityStateZIPSite coordinators
Rheumatology Associates, PCBirminghamAlabama35205-
Rheumatology Associates of North Alabama, PCHuntsvilleAlabama35801-
Arizona Arthritis & Rheumatology Associates, P.C.GlendaleArizona85306-
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage HealthcareFullertonCalifornia92835-
Desert Medical AdvancesPalm DesertCalifornia92260-
San Diego Arthritis Medical ClinicSan DiegoCalifornia92108-
Stanford Anatomic Pathology and Clinical LabStanfordCalifornia94305-
Stanford Health Care Department of Pharmacy lnvestigational Drug ServicesStanfordCalifornia94305-
Stanford University Hospitals and ClinicsStanfordCalifornia94305-
New England Research Associates, LLCBridgeportConnecticut06606-
Rheumatology Associates of Central Florida, PAOrlandoFlorida32806-
Millennium ResearchOrmond BeachFlorida32174-
Arthritis Center, Inc.Palm HarbourFlorida34684-
Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology SpecialistsPlantationFlorida33324-
Florida Medical Clinic, P.A.ZephyrhillsFlorida33542-
St. Luke's Clinic - RheumatologyBoiseIdaho83702-
St. Luke's Intermountain Research CenterBoiseIdaho83702-
Bluegrass Community Research, Inc.LexingtonKentucky40504-
Klein and Associates, M.D., P.A.HagerstownMaryland21740-
The Center for Rheumatology and Bone ResearchWheatonMaryland20902-
Brigham & Women's HospitalBostonMassachusetts02115-
Clinical Pharmacology Study GroupWorcesterMassachusetts01605-
St. Paul Rheumatology, P.A.EaganMinnesota55121-
Clayton Medical ResearchSt LouisMissouri63117-
Physician Research Collaboration, LLCLincolnNebraska68516-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Cincinnati Rheumatic Disease Study Group, Inc.CincinnatiOhio45242-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
University Hospitals of Cleveland Medical CenterClevelandOhio44106-
Paramount Medical Research & Consulting, LLCMiddleburg HeightsOhio44130-
East Penn Rheumatology Associates, PCBethlehemPennsylvania18015-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Articularis Healthcare Group, Inc d/b/a Low Country RheumatologySummervilleSouth Carolina29486-
Arthritis ClinicJacksonTennessee38305-
West Tennessee Research InstituteJacksonTennessee38305-
Adriana Pop-Moody MD Clinic PACorpus ChristiTexas78404-
Pioneer Research Solutions, Inc.CypressTexas77429-
Investigational Drug ServicesSalt Lake CityUtah84112-
University of Utah Hospital & ClinicsSalt Lake CityUtah84132-
University of Utah Hospitals and Clinics - Clinie 2Salt Lake CityUtah84132-
Seattle Rheumatology AssociatesSeattleWashington98122-
Swedish Medical CenterSeattleWashington98104-
Swedish Medical CenterSeattleWashington98122-

Find similar trials in Birmingham, AL

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Rheumatology Associates, PC· Birmingham, ALRheumatology Associates of North Alabama, PC· Huntsville, ALArizona Arthritis & Rheumatology Associates, P.C.· Glendale, AZSt. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare· Fullerton, CADesert Medical Advances· Palm Desert, CASan Diego Arthritis Medical Clinic· San Diego, CA

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