Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
NCT ID: NCT01786668
Last Updated: 2016-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2013-04-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tofacitinib 2 mg
Tofacitinib 2 mg
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
Tofacitinib 5 mg
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
Tofacitinib 10 mg
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
Placebo
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
Interventions
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Tofacitinib 2 mg
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs
Exclusion Criteria
* Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Desert Medical Imaging
Indian Wells, California, United States
Desert Medical Advances
Palm Desert, California, United States
Arthritis & Rheumatology Associates
Clearwater, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Southwest Florida Clinical Research Center
Tampa, Florida, United States
Covance Central Laboratory Services,Inc
Indianapolis, Indiana, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
Progressive Radiology
Hagerstown, Maryland, United States
Advanced Medical Imaging (MRI center)
Lincoln, Nebraska, United States
Arthritis Center of Nebraska (X-ray center)
Lincoln, Nebraska, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Charlotte Radiology/ Carolina Imaging Services
Ballantyne, North Carolina, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Presbyterian Imaging
Charlotte, North Carolina, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Premier Physicians Centers
Westlake, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
Investigational Drug Service
Seatle, Washington, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Institut de Rhumatologie de Montreal
Montreal, Quebec, Canada
G.R.M.O. Inc
Québec, Quebec, Canada
Artroscan s.r.o.
Ostrava, Czech Republic, Czechia
Revmatologicky ustav
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Mediscan Group s.r.o.
Praha 11- Chodov, , Czechia
Medical Plus
Uherské Hradiště, , Czechia
Charité Universitaetsmedizin Berlin
Berlin, , Germany
Praxis fuer klinische Studien
Hamburg, , Germany
Gemeinschaftspraxis Dres. von Hinueber / Demary
Hildesheim, , Germany
Immunologisches Zentrum Vogelsang-Gommern GmbH
Vogelsang-Gommern, , Germany
Dr. Rethy Pál Korhaz es Rendelointezet, Reumatologia
Békéscsaba, , Hungary
Orszagos Reumatologiai es Fiziotherapias Intezet II. Reumatologiai Osztaly
Budapest, , Hungary
Qualiclinic Kft
Budapest, , Hungary
Synexus Magyarorszag Kft. - Synexus Hungary Clinical Research Centre
Budapest, , Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, , Hungary
CRU Hungary Kft.
Szikszó, , Hungary
Csolnoky Ferenc Korhaz Reumatologiai Osztaly
Veszprém, , Hungary
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, Masovian Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych
Bialystok, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Katowice
Katowice, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Torun, , Poland
Federal State Budgetary Institution
Moscow, , Russia
OOO AVA-PETER "Scandinavia clinic"
Saint Petersburg, , Russia
Saint-Petersburg State Budgetary Healthcare Institution
Sestroretsk, , Russia
SBEI HPE Ural State Medical University of MoH of RF based on Municipal Budgetary Institution
Yekaterinburg, , Russia
Chonnam National University Hospital
Gwangju, , South Korea
INHA University Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Complexo Hospitalario Universitario A Coruna
A Coruña, A Coruna, Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, Spain
Hospital Universitario De La Paz
Madrid, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China medical university hospital
Taichung, , Taiwan
Countries
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References
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Deodhar A, Akar S, Curtis JR, El-Zorkany B, Magrey M, Wang C, Wu J, Makgoeng SB, Vranic I, Menon S, Fleishaker DL, Diehl AM, Fallon L, Yndestad A, Landewe RBM. Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis. Adv Rheumatol. 2024 Dec 18;64(1):87. doi: 10.1186/s42358-024-00402-x.
Norton H, Sliwinska-Stanczyk P, Hala T, El-Zorkany B, Stockert L, Mundayat R, Wang L, Ritchlin CT. Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials. Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5.
Deodhar A, Baraliakos X, Magrey M, Gensler LS, Thorat AV, Pemmaraju SK, Cadatal MJ, Nash P. Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. 2024 Aug 1;51(8):772-780. doi: 10.3899/jrheum.2023-1198.
Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
Magrey M, Wei JC, Yndestad A, Bushmakin AG, Cappelleri JC, Dina O, Deodhar A. Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials. Arthritis Care Res (Hoboken). 2024 Mar;76(3):359-365. doi: 10.1002/acr.25267. Epub 2024 Jan 5.
Ostergaard M, Wu J, Fallon L, Sherlock SP, Wang C, Fleishaker D, Kanik KS, Maksymowych WP. Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial. Rheumatol Ther. 2023 Aug;10(4):1001-1020. doi: 10.1007/s40744-023-00564-y. Epub 2023 Jun 18.
Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.
van der Heijde D, Deodhar A, Wei JC, Drescher E, Fleishaker D, Hendrikx T, Li D, Menon S, Kanik KS. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2017 Aug;76(8):1340-1347. doi: 10.1136/annrheumdis-2016-210322. Epub 2017 Jan 27.
Related Links
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Other Identifiers
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2011-005689-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921119
Identifier Type: -
Identifier Source: org_study_id
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