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

Ankylosing Spondylitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786668
• Other study ID #: A3921119
• Secondary ID: 2011-005689-39
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2013
• Last updated: April 20, 2015
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Institut de Rhumatologie de Montreal	Montreal	Quebec
Canada	G.R.M.O. Inc	Quebec
Czech Republic	Artroscan s.r.o.	Ostrava
Czech Republic	Mediscan Group	Praha 11
Czech Republic	Revmatologicky ustav	Praha 2
Czech Republic	Revmatologicka ambulance	Praha 4
Czech Republic	Medical Plus	Uherske Hradiste
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	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
Hungary	Dr. Rethy Pál Korhaz es Rendelointezet, Reumatologia	Békéscsaba
Hungary	országos Reumatológiai és Fizioterápiás Intézet	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	Veszprem
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	INHA University Hospital	Incheon
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych	Bialystok
Poland	Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej	Bydgoszcz
Poland	MRI Unit: NZOZ MCD VOXEL	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im. Dr J. Biziela	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	MRI Unit: Voxel S.A.	Katowice
Poland	Malopolskie Centrum Medyczne S.C.	Krakow
Poland	Zespol Poradni Specjalistycznych Reumed Filia Onyksowa	Lublin
Poland	NZOZ Lecznica MAK-MED s.c.	Nadarzyn	Mazowieckie/Poland
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sol
Poland	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu	Torun
Russian Federation	Federal State Budgetary Institution	Moscow
Russian Federation	OOO AVA-PETER Scandinavia clinic	Saint Petersburg
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution	Sestroretsk
Russian Federation	Municipal Budgetary Institution "Central City Clinical Hospital #6"	Yekaterinburg
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
Spain	Hospital San Rafael	A Coruna
Spain	Cetir, Centre Mèdic, S.L	Barcelona
Spain	Radiodiagnostic Cetir-Clinica Del Pilar, S.L	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	RESSALTA	Cordoba
Spain	Clinica Diagonal	Esplugues de Llobregat	Barcelona
Spain	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario De La Paz	Madrid
Spain	Corporacio Sanitaria Parc Tauli	Sabadell
Spain	Corporació Sanitaria Parc Tauli - Servicio de Farmacia	Sabadell
Spain	Drug Shipment Address - Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	XRAY/MRI Facility	Santander	Cantabria
Spain	Hospital Clinico de Santiago	Santiago de Compostela	A Coruña
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China medical university hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
United States	Joint and Muscle Research Institute	Charlotte	North Carolina
United States	Presbyterian Imaging	Charlotte	North Carolina
United States	Arthritis & Rheumatology Associates	Clearwater	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Klein & Associates, M.D., P.A.	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	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio
United States	Millennium Research	Ormond Beach	Florida
United States	Desert Medical Advances	Palm Desert	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	Arthritis Northwest, PLLC	Spokane	Washington
United States	Southwest Florida Clinical Research Center	Tampa	Florida
United States	Clinical Research Center of Reading, LLC	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment in Ankylosing Spondylitis (ASAS) 20	ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change = 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for = 3 domains, and no worsening in remaining domain.	12 weeks	No
Secondary	Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score and/or modified Berlin Ankylosing Spondlylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the SI joints and spine		Baseline, Week 12	No
Secondary	Assessment in Ankylosing Spondylitis (ASAS) 20	ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change = 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for = 3 domains, and no worsening in remaining domain.	Baseline, Week 2, Week 4, Week 8	No
Secondary	Assessment in Ankylosing Spondylitis (ASAS) 40	ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change = 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for = 3 domains, and no worsening in remaining domain.	Baseline, Week 2, Week 4, Week 12	No
Secondary	Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.	ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in = 5 domains and no worsening in the remaining domain.	Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Achieving Ankylosing Spondlylitis Disease Activity Score using C-Reactive Protein (ASDAS(CRP))		Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Achieving Ankylosing Spondlylitis Disease Activity Score (ASDAS) clinically important improvement		Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Achieving Ankylosing Spondlylitis Disease Activity Score (ASDAS)major improvement		Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Achieving Ankylosing Spondlylitis Disease Activity Score (ASDAS) inactive disease		Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.	Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response	BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.	Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)	BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.	Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Bath Ankylosing Spondylitis Metrology Index (BASMI) Score	BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.	Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Masstricht Ankylosing Spondylitis Enthesitis Score (MASES)		Baseline, Week 4, Week 8, Week 12	No
Secondary	Extra-articular Involvement as assessed by swollen joints		Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	Spinal mobility as assessment by chest expansion		Baseline, Week 2, Week 4, Week 8, Week 12	No
Secondary	36-Item Short-Form Health Survey (SF-36)	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline, Week 12	No
Secondary	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Day 1 and Week 12	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (	Baseline, Week 12	No
Secondary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)		Baseline, Week 2, Week 4, Week 8, Week 12	No

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