Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes

PHASE3CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

October 31, 2014

Conditions
Spondylitis, Ankylosing
Interventions
BIOLOGICAL

etanercept

In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

DRUG

Background NSAID

Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.

OTHER

PLACEBO

In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

DRUG

Background NSAID

Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).

Trial Locations (50)

112

Taipei Veterans General Hospital, Taipei

807

Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung City

1023

Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly, Budapest

1027

Budai Irgalmasrendi Korhaz, Budapest

1036

Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft., Budapest

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft., Budapest

3500

Reuma Instituut, Hasselt

4031

Kenezy Gyula Korhaz es Rendelointezet, Debrecen

8200

Csolnoky Ferenc Korhaz, Veszprém

8500

AZ Groeninge, Kortrijk

9000

Universitair Ziekenhuis Gent, Ghent

12203

Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie, Berlin

14004

Hospital Reina Sofia, Córdoba

14800

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

15006

Complexo Hospitalario Universitario A Coruña, A Coruña

22081

Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie, Hamburg

28922

Fundacion Hospital Alcorcon, Alcorcón

34000

CHU Lapeyronie, Immuno-Rhumatologie, Montpellier

37044

CHU de Tours, Tours

39245

MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH, Vogelsang-Gommern

40201

Chung Shan Medical University Hospital, Taichung

41009

Hospital Virgen Macarena, Seville

44649

Rheumazentrum Ruhrgebiet, Herne

68601

Medical Plus s.r.o., Uherské Hradiště

75014

Hôpital Cochin, Paris

91054

Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen, Erlangen

94270

Hopital de Bicetre, Le Kremlin-Bicêtre

115522

Rheumatology Research Institute of Russian Academy of Medical Sciences, Moscow

121552

Russian Cardiology Research-and-Production Complex, Moscow

190068

Saint-Petersburg State Budgetary Healthcare Institution, Saint Petersburg

191014

Limited Liability Company NMC Tomography, Saint Petersburg

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

C1428DZF

Consultorios Reumatológicos Pampa, Buenos Aires

Unknown

Preventive Care Ltda., Chía

Ips Medicity S.A.S, Bucaramanga

Servimed Sas, Bucaramanga

128 50

Revmatologicky ustav, Prague

00029

Meilahden kolmiosairaala, Helsinki

05800

Kiljavan Lääketutkimus, Hyvinkää

1105 AZ

Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology, Amsterdam

2333 ZA

Leiden University Medical Center, Reumatologie, Leiden

405-760

Gachon University Gil Hospital, Incheon

501-757

Chonnam National University Hospital, Gwangju

133-792

Hanyang University Hospital, Seoul

CB2 0QQ

Rhuematology Clinical Research Unit, Cambridge

RG24 9NA

Hampshire Hospitals NHS Foundation Trust, Basingstoke

NR4 7UY

Norfolk and Norwich University Hospital NHS Trust, Norwich

DY1 2HQ

Russells Hall Hospital, Dudley

E11 1NR

Whipps Cross University Hospital,, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY