Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

December 3, 2019

Primary Completion Date

January 19, 2021

Study Completion Date

May 11, 2021

Conditions
Psoriatic Arthritis
Interventions
DRUG

Filgotinib

Tablets administered orally once daily with or without food

DRUG

Adalimumab

Injection administered subcutaneously once every 2 weeks

DRUG

Placebo to match filgotinib

Tablets administered orally once daily with or without food

DRUG

Placebo to match adalimumab

Injection administered subcutaneously once every 2 weeks

Trial Locations (74)

204

Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital, Keelung

220

Far Eastern Memorial Hospital, New Taipei City

622

Buddhist Dalin Tzu Chi Hospital, Dailin Township

833

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

1010

Optimal Clinical Trials, Auckland

1036

Synexus (DRS) - Synexus Magyarorszag Kft. Budapest, Budapest

1336

"Multiprofile Hospital for Active Treatment Lyulin EAD, Department of Rheumatology", Sofia

1505

Diagnostic consultative center 17 Sofia EOOD, Sofia

1784

"Medical center Synexus Sofia EOOD", Sofia

2292

Genesis Research Services, Broadmeadow

3124

Emeritus Research, Camberwell

3240

Waikato Hospital, Hamilton

4003

University Multiprofile Hospital for Active Treatment - Plovdiv AD, Department Of Rheumatology, Plovdiv

4558

Rheumatology Research Unit, Maroochydore

5700

Synexus (DRS) - Synexus Magyarorszag Kft. Gyula, Gyula

6000

"Medical center SYNEXUS SOFIA EOOD, branch Stara Zagora", Stara Zagora

6021

Capital & Coast District Health Board, Newtown

7910

Clinical Trials Unit, Timaru Hospital, Timaru

8208

Corporacio Sanitaria Parc Tauli, Sabadell

11031

Taipei Medical University Hospital, Taipei

13496

CHA Bundang Medical Center, CHA University, Seongnam

16635

Altoona Center for Clinical Research, Duncansville

21740

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

25309

West Virginia Research Institute PLLC, South Charleston

28041

Hospital Universitario 12 de Octubre, Avenida de Cordoba s/n, Rheumatology Service, Madrid, Spain, 28041, Madrid

28204

Joint and Muscle Research Institute, Charlotte

29118

ACME Research, LLC, Orangeburg

29204

Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA, Columbia

30046

North Georgia Rheumatology Group, Lawrenceville

32713

Omega Research Debary, LLC, DeBary

32819

Hmd Research Llc, Orlando

33015

San Marcus Research Clinic, Inc., Miami

33511

Bay Area Arthritis and Osteoporosis, Brandon

33613

ForCare Clinical Research, Tampa

33614

BayCare Medical Group, Inc., Tampa

39008

Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, Santander, Cantabria, 39008, Santander

41007

Hospital Universitario Virgen Macarena, Seville

43551

Clinical Research Source Inc, Perrysburg

44130

Paramount Medical Research & Consulting, LLC, Middleburg Heights

48081

Clinical Research Institute of Michigan, LLC, Saint Clair Shores

55121

St. Paul Rheumatology, P.A., Eagan

62096

NSZOZ Unica CR, Dabrówka

63141

Arthritis Consultants, Inc., St Louis

68516

Physician Research Collaaboration, LLCs, Lincoln

70403

National Cheng Kung University Hospital, Tainan City

71004

Chi Mei Medical Center, Tainan City

75150

Southwest Rheumatology Research, LLC, Mesquite

77845

Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address), College Station

85234

Arthritis Center, Inc., Palm Harbor

91723

Medvin Clinical Research, Covina

127473

Ulitsa Delegatskaya, 20, Building 1, Ulitsa Kasatkina, 7 Moscow, Russia, 127473/129301, Moskva

150003

Center for medical advice and research - PRACTICE LTD, Yaroslavl

600005

"LLC Biomed", Vladimir

08755

Atlantic Coast Research, Toms River

G1V3M7

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc., Québec

702 00

CCR Ostrava, s.r.o., Ostrava

586-8521

National Hospital Organization Osaka Minami Medical Center, Kawachi-Nagano

457-8511

Daido Clinic, Nagoya

467-8602

Nagoya City University Hospital, Nagoya

160-8582

Keio University Hospital, Tokyo

15-099

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk, Bialystok, Podlaskie

85-168

Szpital Uniwersytecki nr 2 im. dr Jana Biziela, Bydgoszcz

81-338

Centrum Medyczne Pratia Gdynia, Gdynia

30-349

Malopolskie Badania Kliniczne SP Z O O Sp. k., Krakow

05-830

NZOZ Lecznica MAK-MED s.c., Nadarzyn

10-117

ETYKA Osrodek Badan Klinicznych, Olsztyn

00-874

Medycyna Kliniczna Marzena Waszczak-Jeka, Warsaw

02-118

Pheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw

03-921

Centrum Medyczne AMED Warszawa, Warsaw

04-305

REUMATOLOG WARSZAWA Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler, Warsaw

02-691

"ARS RHEUMATICA Sp. Z.o.o., REUMATIKA-Centrum Reumatologii, NZOZ", Warszawa, Mazowieckie

52-416

Centrum Medyczne Oporow, Wroclaw

03080

Seoul National University Hospital, Seoul

07061

SMG - SNU Boramae Medical Center, Seoul

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Galapagos NV

INDUSTRY

lead

Gilead Sciences

INDUSTRY