PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

September 27, 2010

Primary Completion Date

July 26, 2012

Study Completion Date

January 25, 2017

Conditions
Psoriatic Arthritis
Interventions
DRUG

Apremilast 20mg

Apremilast 20 mg twice daily, orally

DRUG

Apremilast 30mg

Apremilast 30 mg twice daily, orally

DRUG

Placebo + 20 mg Apremilast

Placebo + 20 mg Apremilast

DRUG

Placebo + 30 mg Apremilast

Placebo + 30 mg Apremilast

Trial Locations (98)

2

Jacaranda Hospital, Pretoria

106

Cathay General Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

402

Chung Shan Medical University Hospital, Taichung

1020

CHU Brugmann, Brussels

1233

Diagnostic and Consulting Centre 7, Sofia

1407

University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia, Sofia

1505

17 Diagnostic and Consulting Centre Sofia EOOD, Sofia

1612

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski, Sofia

1709

Diagnostic-Consultative Center Sveta Anna, Sofia

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

3000

UZ Leuven, Leuven

4000

University Hospital of Liege CHU Liege, Liège

4032

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen

4091

Nelson Mandela School Of Medicine, Durban

4103

Synexus Clinical Research GmbH, Leipzig

6057

Greenacres Hospital, Port Elizabeth

6611

New England Research Associates, LLC, Trumbull

6900

Principal SMO Kft., Makó

9000

UZ Gent, Ghent

9010

Diagnostic and Consulting Centre 4, Varna

10002

National Taiwan University Hospital, Tapei

10117

Charite - Universitätsmedizin Berlin, Berlin

14623

University of Rochester Medical Center, Rochester

16132

Azienda Ospedaliera Universitaria San Martino, Genova

19090

Rheumatic Disease Associates, Willow Grove

20157

Ospedale Luigi Sacco, Milan

27100

IRCCS Policlinico San Matteo, Pavia

27408

Vital Research, Greensboro

28602

Unifour Medical Research Associatets LLC, Hickory

29009

Hospital General Carlos Haya, Málaga

30342

Arthritis and Rheumatology of Georgia, Atlanta

33334

Centre For Rheumatology, Immun. And Arthritis, Fort Lauderdale

33612

University of South Florida, Tampa

33710

DMI Research, St. Petersburg

35406

Clinical and Translational Research Center of Alabama, PC, Tuscaloosa

37126

Ospedale Civile Maggiore Borgo Trento, Verona

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

38642

Praxis Karin Rockwitz, Goslar

39300

Hospital Sierrallana, Torrelavega

40705

Taichung Veterans General Hospital, Taichung

48910

Advanced Rheumatology, Lansing

49015

Associated Internal Medical Specialist, PC, Battle Creek

50106

Clinical Research Centre Ltd, Tartu

53132

Rheumatology and Immunotherapy Center, Franklin

55905

Mayo Clinic, Rochester

56126

Universita di Pisa, Pisa

59901

Research West Incorporated, Kalispell

60005

Michael Bukhalo MD SC, Arlington Hts

60590

Klinikum der Johann-Wolfgang Goethe-Universität, Frankfurt

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75010

Hopital Lariboisiere, Paris

75014

Fondation Hôpital Saint-Joseph, Paris

75231

Metroplex Clinical Research Center, Dallas

75321

Arthritis Care and Diagnostic Center, Dallas

75651

Groupe Hospitalier Pitié- Salpétrière, Paris

78232

Luckster Enterprises, San Antonio

80130

Seconda Universita degli Studi di Napoli, Napoli

80230

Denver Arthritis Clinic, Denver

87042

Hopital Universitaire Dupuytren, Limoges

98104

Seattle Rheumatology Associates, Seattle

98405

Tacoma Center for Arthritis Research, PS, Tacoma

119049

City Clinical Hospital #1 n.a. N.I.Pirogov, Moscow

150062

Yaroslavl Regional Clinical Hospital, Yaroslavl

195067

St.Petersburg State Medical Academy n. a. I.I.Mechnikov, Saint Petersburg

603005

City Clinical Hospital #5, Nizhny Novgorod

75246-1613

Baylor Research Institute, Dallas

T5M 0H4

Rheumatology Research Associates, Edmonton

V8P5P6

PerCuro Clinical Research, Victoria

L7L0B7

Anna Jaroszynska Private Practice, Burlington

L8N1Y2

William Bensen's Private Practice, Hamilton

P1B 3Z7

North Bay Dermatology Center, North Bay

K1H 1A2

Rheumatology Research Associates, Ottawa

L4J1W3

Wilderman Medical Clinic, Thornhill

N8W 1E6

Darryl Toth's Private Practice, Windsor

638 00

Revmatologie s.r.o., Brno

370 01

MEDIPONT PLUS s.r.o.., České Budějovice

748 01

L.K.N. Arthrocentrum s.r.o., Hlučín

253 01

ARTMEDI UPD s.r.o., Hostivice

128 50

Revmatologicky ustav, Prague

140 00

Revmatologicka Ambulance, Prague

148 00

Affidea Praha s.r.o, Prague

356 01

Revmatologicka Ambulance, Sokolov

760 01

PV - MEDICAL, s.r.o., Zlín

EE-80010

Parnu Hospital, Pärnu

EE-11412

East Tallinn Central Hospital, Tallinn

EE-13419

North Estonia Regional Hospital, Tallinn

EE-51014

Tartu University Hospital, Tartu

15-351

NZOZ Osteo-Medic sc A. Racewicz J. Supronik, Bialystok

20-582

Niepubliczny Zaklad Opieki Zdrowotnej REUMED, Lublin

00-909

Wojskowy Instytut Medyczny, Warsaw

02-637

Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Warsaw

50-088

Synexus SCM Sp. z o.o., Wroclaw

RG24 9NA

Basingstoke and North Hampshire Hospital, Basingstoke

WS11 5XY

Cannock Chase Hospital, Cannock

LS7 4SA

Chapel Allerton Hospital, Leeds

BH 1 5JB

Poole Hospital, Poole

SN3 6BB

Great Western Hospital, Swindon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY