Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

PHASE3CompletedINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

May 2, 2012

Primary Completion Date

February 24, 2014

Study Completion Date

October 25, 2018

Conditions
Ankylosing Spondyloarthritis
Interventions
DRUG

Apremilast tablet 20 mg

Apremilast 20 mg was taken orally twice a day (BID)

DRUG

Apremilast tablet 30 mg BID

Apremilast 30 mg was taken orally twice a day

DRUG

Placebo

Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.

Trial Locations (103)

1036

Qualiclinic kft, Budapest

Synexus Magyarország Kft., Budapest

1130

Krankenhaus Wien-Hietzing, Vienna

1233

National Multiprofile Transport Hospital Tzar Boris III, Sofia

1505

17 Diagnostic and Consulting Centre, Sofia

1606

Military Medical Academy - MHAT, Sofia

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

3124

Emeritus Research, Camberwell

4032

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen

4558

Coastal Joint Care, Maroochydore

5011

The Queen Elizabeth Hospital, Woodville South

5800

Diagnostic and Consulting Center Sv. Pantaleymon, Pleven

6849

Royal Perth Hospital, Perth

7000

Southern Clinical Research, Hobart

8200

Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet, Veszprém

9010

Diagnostic Consulting Center N4, Varna

10117

Innomedica Medical and Research Centre, Tallinn

11412

East Tallinn Central Hospital, Tallinn

12203

Charite - Universitätsmedizin Berlin, Berlin

14001

Hospital Universitario Reina Sofia, Córdoba

15006

Hospital Universitario a Coruna, A Coruña

15706

Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n, Santiago de Compostela

16635

Altoona Center for Clinical Research, Duncansville

20502

Skånes Universitetssjukhus- Malmö, Malmo

21502

Klein and Associates MD, PA, Cumberland

21740

Klein and Associates MD, PA, Hagerstown

22081

Schön Klink Hamburg-Eilbek, Hamburg

28007

Hospital General Universitario Gregorio Maranon, Madrid

32960

Alastair Kennedy, MD Research, Vero Beach

33614

Burnette & Silverfield, MDS PLC, Tampa

33781

Advent Clinical Research Centers, Inc, Pinellas Park

38119

Ramesh C Gupta MD, Memphis

38305

The Arthritis Clinic, Jackson

44109

MetroHealth Medical Systems, Cleveland

44649

Rheumazentrum Ruhrgebiet, Herne

45067

IPROS - CHR ORLEANS - Hôpital de la Source, Orléans

45417

STAT Research, Inc., Dayton

50106

Clinical Research Centre Ltd, Tartu

51014

Tartu University Hospital, Tartu

53132

Rheumatology and Immunotherapy Center, Franklin

55121

Saint Paul Rheumatology, PA, Eagan

60528

Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH, Frankfurt

60611

Northwestern Medical Faculty Foundation, Chicago

69120

Universitatsklinikum Heidelberg, Heidelberg

75014

Hopital Cochin, Paris

75651

Groupe Hospitalier Pitié- Salpétrière, Paris

78731

Austin Regional Clinic, Austin

84132

University of Utah Hospitals and Clinics, Salt Lake City

85381

Sun Valley Arthritis Center, Peoria

91054

Universitatsklinikum Erlangen, Erlangen

92100

Hopital Ambroise-Pare, Boulogne

92260

Desert Medical Advances, Palm Desert

94010

Hopital Henri Mondor, Créteil

115522

"Federal State Budget Institution Rheumatology Research Institute RAMS", Moscow

214025

Departmental Hospital at Smolensk Station RZhD JSC, Smolensk

400006

Emergency County Clinical Hospital, Cluj-Napoca

420103

Research Medical Complex Vashe Zdorovie, Kazan'

600023

Regional Clinical Hospital, Vladimir

603005

Nizhniy Novgorod State Medical Academy of Roszdrav, Nizhny Novgorod

620102

Sverdlovsk Regional Clinical Hospital 1, Yekaterinburg

650066

Kemerovo Regional Clinical Hospital, Kemerovo

700127

RK Medcenter SRL, Iași

800578

Sf Apostol Andrei Emergency Clinical County Hospital, Galati

810019

Cristei R. Rodica - Private Medical Practice, Brăila

92093-0943

University of California, San Diego, La Jolla

94143-0326

UCSF Arthritis Center, San Francisco

01605

Clinical Pharmacology Study Group, Worcester

T2N 4Z6

Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW), Calgary

A1A 5EB

Nexus Clinical Research, St. John's

L8N 2B6

Cividino Medicine Professional Corporation, Hamilton

L8N1Y2

Dr. William G. Bensen Medicine Professional Corporation, Hamilton

L5M 2V8

Credit Valley Professional Building, Mississauga

L3Y 3R7

The Arthritis Program Research Group Inc., Newmarket

K1H1A2

Rheumatology Research Associates, Ottawa

M5T 258

Toronto Western Hospital, Toronto

G1W 4R4

Centre de Recherche Saint-Louis, Saint-Louis

638 00

Revmatologie s.r.o., Brno

253 01

ARTMEDI UPD s.r.o., Hostivice

530 02

ARTHROMED s.r.o., Pardubice

140 00

Revmatologicka Ambulance, Prague

140 59

Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka, Prague

148 00

Medifin a.s, Šustova, Prague

356 01

Revmatologicka Ambulance, Sokolov

760 01

PV-Medical s.r.o., Zlín

2333 ZA

Leiden Universitair Medisch Centrum, Leiden

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

15-099

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk, Bialystok

15-351

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

85-168

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

81-537

Synexus SCM Sp. z o.o., Gdynia

20-582

Zespol Poradni Specjalistycznych, Lublin

61-397

Prywatna Praktyka Lekarska Pawel Hrycaj, Poznan

87-100

NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna, Torun

50-088

Synexus SCM Sp. z o.o., Wroclaw

011172

Sf. Maria Clinical Hospital, Bucharest

921 12

Narodny ustav reumatickych chorob, Piešťany

058 01

MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia, Poprad

08907

Hospital de Bellvitge, Barcelona

08208

Corporacio Sanitaria Parc Tauli de Sabadell, Sabadell

S75 2EP

Barnsley Hospital, Barnsley

BA1 1RL

Royal National Hospital for Rheumatic Diseases, Bath

LS7 4SA

Chapel Allerton Hospital, Leeds

OX3 7LD

Nuffield Orthopaedic Centre, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT01583374 - Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis | Biotech Hunter | Biotech Hunter