Clinical trial NCT01786668: Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Spondylitis
Ankylosing
Spondyloarthritis
Spondyloarthropathy
Oral preparation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Ankylosing Spondylitis
* Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs

Exclusion Criteria:

* Pregnant or lactating females
* Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent

Primary outcomes:
measure: Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving ASAS20 at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8
timeFrame: Baseline, Week 2, Week 4, Week 8
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
timeFrame: Baseline, Week 12 and Follow-up
measure: Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Indian Wells
country: United States
facility: Desert Medical Imaging
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Clearwater
country: United States
facility: Arthritis & Rheumatology Associates
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: Indianapolis
country: United States
facility: Covance Central Laboratory Services,Inc
state: Indiana
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Hagerstown
country: United States
facility: Progressive Radiology
state: Maryland
city: Lincoln
country: United States
facility: Advanced Medical Imaging (MRI center)
state: Nebraska
city: Lincoln
country: United States
facility: Arthritis Center of Nebraska (X-ray center)
state: Nebraska
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Ballantyne
country: United States
facility: Charlotte Radiology/ Carolina Imaging Services
state: North Carolina
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Imaging
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Westlake
country: United States
facility: Premier Physicians Centers
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Seatle
country: United States
facility: Investigational Drug Service
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Montreal
country: Canada
facility: Institut de Rhumatologie de Montreal
state: Quebec
city: Quebec
country: Canada
facility: G.R.M.O. Inc
city: Ostrava
country: Czech Republic
facility: Artroscan s.r.o.
city: Praha 11- Chodov
country: Czech Republic
facility: Mediscan Group s.r.o.
city: Praha 2
country: Czech Republic
facility: Revmatologicky ustav
city: Praha 4
country: Czech Republic
facility: Revmatologicka ambulance
city: Uherske Hradiste
country: Czech Republic
facility: Medical Plus
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Hamburg
country: Germany
facility: Praxis fuer klinische Studien
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dres. von Hinueber / Demary
city: Vogelsang-Gommern
country: Germany
facility: Immunologisches Zentrum Vogelsang-Gommern GmbH
city: Budapest
country: Hungary
facility: Orszagos Reumatologiai es Fiziotherapias Intezet II. Reumatologiai Osztaly
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft. - Synexus Hungary Clinical Research Centre
city: Békéscsaba
country: Hungary
facility: Dr. Rethy Pál Korhaz es Rendelointezet, Reumatologia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum
city: Szikszó
country: Hungary
facility: CRU Hungary Kft.
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Korhaz Reumatologiai Osztaly
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: INHA University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED s.c.
state: Mazowieckie
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
city: Katowice
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Katowice
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
city: Ekaterinburg
country: Russian Federation
facility: SBEI HPE Ural State Medical University of MoH of RF based on Municipal Budgetary Institution
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution
city: Saint-Petersburg
country: Russian Federation
facility: OOO AVA-PETER "Scandinavia clinic"
city: Sestroretsk
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: A Coruna
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario De La Paz
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China medical university hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.