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

PHASE2CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Ankylosing Spondylitis
Interventions
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

DRUG

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

DRUG

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

DRUG

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

Trial Locations (67)

1023

Orszagos Reumatologiai es Fiziotherapias Intezet II. Reumatologiai Osztaly, Budapest

1036

Qualiclinic Kft, Budapest

Synexus Magyarorszag Kft. - Synexus Hungary Clinical Research Centre, Budapest

3800

CRU Hungary Kft., Szikszó

4032

Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Debrecen

5600

Dr. Rethy Pál Korhaz es Rendelointezet, Reumatologia, Békéscsaba

12203

Charité Universitaetsmedizin Berlin, Berlin

14004

Hospital Universitario Reina Sofia, Córdoba

14800

Mediscan Group s.r.o., Praha 11- Chodov

15006

Complexo Hospitalario Universitario A Coruna, A Coruña

15706

Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela

16635

Altoona Center for Clinical Research, Duncansville

19610

Clinical Research Center of Reading, LLC, Wyomissing

21740

Klein & Associates, M.D., P.A., Hagerstown

Progressive Radiology, Hagerstown

22415

Praxis fuer klinische Studien, Hamburg

28046

Hospital Universitario De La Paz, Madrid

28204

Joint and Muscle Research Institute, Charlotte

28207

Presbyterian Imaging, Charlotte

28277

Charlotte Radiology/ Carolina Imaging Services, Ballantyne

31134

Gemeinschaftspraxis Dres. von Hinueber / Demary, Hildesheim

32174

Millennium Research, Ormond Beach

33609

Southwest Florida Clinical Research Center, Tampa

33756

Arthritis & Rheumatology Associates, Clearwater

39008

Hospital Universitario Marques de Valdecilla, Santander

39245

Immunologisches Zentrum Vogelsang-Gommern GmbH, Vogelsang-Gommern

40201

Chung Shan Medical University Hospital, Taichung

40447

China medical university hospital, Taichung

44130

Paramount Medical Research & Consulting, LLC, Middleburg Heights

44145

Premier Physicians Centers, Westlake

46214

Covance Central Laboratory Services,Inc, Indianapolis

68506

Advanced Medical Imaging (MRI center), Lincoln

68516

Arthritis Center of Nebraska (X-ray center), Lincoln

Physician Research Collaboration, LLC, Lincoln

68601

Medical Plus, Uherské Hradiště

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

92210

Desert Medical Imaging, Indian Wells

92260

Desert Medical Advances, Palm Desert

97239

Oregon Health & Science University, Portland

98122

Investigational Drug Service, Seatle

Seattle Rheumatology Associates, Seattle

99204

Arthritis Northwest, PLLC, Spokane

115522

Federal State Budgetary Institution, Moscow

191014

"OOO AVA-PETER Scandinavia clinic", Saint Petersburg

197706

Saint-Petersburg State Budgetary Healthcare Institution, Sestroretsk

620149

SBEI HPE Ural State Medical University of MoH of RF based on Municipal Budgetary Institution, Yekaterinburg

H2L 1S6

Institut de Rhumatologie de Montreal, Montreal

G1V 3M7

G.R.M.O. Inc, Québec

722 00

Artroscan s.r.o., Ostrava

128 50

Revmatologicky ustav, Prague

140 00

Revmatologicka ambulance, Prague

H-8200

Csolnoky Ferenc Korhaz Reumatologiai Osztaly, Veszprém

05-830

NZOZ Lecznica MAK-MED s.c., Nadarzyn

15- 879

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych, Bialystok

85-168

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy, Bydgoszcz

82-300

Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska, Elblag

40-954

Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Katowice, Katowice

30-510

Malopolskie Centrum Medyczne S.C., Krakow

20-582

Zespol Poradni Specjalistycznych Reumed Filia Onyksowa, Lublin

67-100

Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sól

87-100

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu, Torun

501-757

Chonnam National University Hospital, Gwangju

400-711

INHA University Hospital, Incheon

110-744

Seoul National University Hospital, Seoul

443-721

Ajou University Hospital, Suwon

08908

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

08208

Corporacio Sanitaria Parc Tauli, Sabadell

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01786668 - Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis | Biotech Hunter | Biotech Hunter