Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Part of paid clinical trials in Indian Wells, California.

Sponsor
Pfizer
Study ID
NCT01786668
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tofacitinib 2 mg — DRUG
    4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Tofacitinib 5 mg — DRUG
    4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Tofacitinib 10 mg — DRUG
    4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Placebo — DRUG
    4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks

Study Details

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

Key Dates

Start date
Apr 30, 2013
Status verified
May 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
208 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib 2 mg
  • Experimental: Tofacitinib 5 mg
  • Experimental: Tofacitinib 10 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12 [ Time Frame: Week 12 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Desert Medical ImagingIndian WellsCalifornia92210-
Desert Medical AdvancesPalm DesertCalifornia92260-
Arthritis & Rheumatology AssociatesClearwaterFlorida33756-
Millennium ResearchOrmond BeachFlorida32174-
Southwest Florida Clinical Research CenterTampaFlorida33609-
Covance Central Laboratory Services,IncIndianapolisIndiana46214-
Klein & Associates, M.D., P.A.HagerstownMaryland21740-
Progressive RadiologyHagerstownMaryland21740-
Advanced Medical Imaging (MRI center)LincolnNebraska68506-
Arthritis Center of Nebraska (X-ray center)LincolnNebraska68516-
Physician Research Collaboration, LLCLincolnNebraska68516-
Charlotte Radiology/ Carolina Imaging ServicesBallantyneNorth Carolina28277-
Joint and Muscle Research InstituteCharlotteNorth Carolina28204-
Presbyterian ImagingCharlotteNorth Carolina28207-
Paramount Medical Research & Consulting, LLCMiddleburg HeightsOhio44130-
Premier Physicians CentersWestlakeOhio44145-
Oregon Health & Science UniversityPortlandOregon97239-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Clinical Research Center of Reading, LLCWyomissingPennsylvania19610-
Investigational Drug ServiceSeatleWashington98122-
Seattle Rheumatology AssociatesSeattleWashington98122-
Arthritis Northwest, PLLCSpokaneWashington99204-

Find similar trials in Indian Wells, CA

By research site
Desert Medical Imaging· Indian Wells, CADesert Medical Advances· Palm Desert, CAArthritis & Rheumatology Associates· Clearwater, FLMillennium Research· Ormond Beach, FLSouthwest Florida Clinical Research Center· Tampa, FLCovance Central Laboratory Services,Inc· Indianapolis, IN

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