This is a two part study. During period one there will be a comparsion of Etanercept
(ETN)against a placebo with both arms maintaining the background anti inflammatory drug
prescribed by their Physician. The hypothesis is that Etanercept will be superior to the
placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing
Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension
where everyone in the trial receives Etanercept (ETN)and a background non steroidal anti
inflammatory drug(NSAID).
Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 40 at time points other than 12 weeks and over timeProportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 20 at 12 weeks and over time
Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 5/6 at 12 weeks and over time
Changes from baseline in Assessments in Ankylosing Spondylitis (ASDAS )at 12 weeks and over time
Proportion of subjects with Assessments in Ankylosing Spondylitis (ASAS) partial remission at 12 weeks and over time
Time to: Assessments in Ankylosing Spondylitis( ASAS) partial remission at 12 weeks and over time
Changes from baseline in Visual Analogue Scale(VAS) Subject Global Assessments at 12 weeks and over time
Changes from baseline in the Visual Analogue Scale(VAS )Physician Global Assessmentat 12 weeks and over time
Changes from baseline in VAS nocturnal and total back pain over time at 12 weeks and over time
Changes from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) and it's components at 12 weeks and over time
Changes from baseline in the Bath Ankylosing Spondylitis Disease Activity Index(BASDAI )and it's components at 12 weeks and over time
Proportion of subjects who achieved Bath Ankylosing Spondylitis Disease Activity Index (BASDAI )20 and BASDAI 50 at 12 weeks and over time
Changes in Bath Ankylosing Spondylitis Global Index (BAS - G) BAS-G at 12 weeks and over time
Changes from baseline in spinal mobility as measured by Bath Ankylosing Spondylitis Metrology Index{BASMI} (and its individual components), and occiput-to-wall distance, and chest expansion at 12 weeks and over time
Changes in inflammation at week 12 as measured by Magnetic resonance imaging (MRI )of the spine at 12 weeks and over time
Changes from baseline in tender and swollen joint counts (44 count) at 12 weeks and over time.
Changes from baseline on dactylitis and enthesitis score (MASES)at 12 weeks and over time.
Changes from baseline in the acute phase reactants C Reactive Protein (CRP) and Erythrocyte sedimentation rate (ESR)at 12 weeks and over time.
Safety will be assessed throughout the study including but not limited to adverse events, and serious adverse events during the study at 12 weeks and over time.
Health Outcome Assessment • EQ D-5: The EuroQol EQ 5D Health State Profile at 12 weeks and over 104 weeks.
Health Outcome Assessment •Short Form -36 Health Survey (SF36) at 12 weeks and over time 104 weeks.
Health Outcome Assessment • Hospital Anxiety and Depression Scale (HADS) at 12 weeks and over time 104 weeks.
Healthoutcomes Assessment: Ankylosing Spondylitis Quality of Life (ASQoL) at 12 weeks and over time 104 weeks.
Healthoutcomes Assessment: Ankylosing Spondylitis Work Instability Index (AS WIS)at 12 weeks and over time 104 weeks.
Health Outcome Assessment Work Productivity and Activity Impairment (WPAI)at 12 weeks and over time 104 weeks.
Health Outcome Assessment Multidimensional Fatigue Inventory (MFI) at 12 weeks and over time 104 weeks.
Health Outcome Assessment : Medical Outcomes Study (MOS) Sleep Scale at 12 weeks and over time 104 weeks.
Health Outcome Assessment :The Minimum Clinically Important Improvement (MCII) at 12 weeks and over time 104 weeks.
Health Outcome Assessment : Patient Acceptable Symptom State (PASS)at 12 weeks and over time 104 weeks.
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Consultorios Reumatológicos Pampa, Buenos Aires C1428DZF, Argentina
Universitair Ziekenhuis Gent, Gent 9000, Belgium
Reuma Instituut, Hasselt 3500, Belgium
AZ Groeninge, Kortrijk 8500, Belgium
Mediscan Group, s.r.o., Praha 11 14800, Czech Republic
Revmatologicky ustav, Praha 2 128 50, Czech Republic
Medical Plus s.r.o., Uherske Hradiste 68601, Czech Republic
Meilahden kolmiosairaala, Helsinki 00290, Finland
Kiljavan Laaketutkimus, Hyvinkaa 05800, Finland
Hopital Bicetre, LE KREMLIN-BICETRE Cedex 94275, France
CHU Lapeyronie, Immuno-Rhumatologie, Montpellier 34000, France
Hôpital Cochin, Paris 75014, France
CHU de Tours, Tours Cedex 9 37044, France
Charite - Campus Benjamin Franklin, Medizinische Klink I - Rheumatologie, Berlin 12203, Germany
Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen, Erlangen 91054, Germany
Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie, Hamburg 22081, Germany
St. Josefs-Krankenhaus, Rheumazentrum Ruhrgebiet, Herne 44652, Germany
MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH, Vogelsang-Gommern 39245, Germany
Budai Irgalmasrendi Korhaz, Budapest 1023, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly, Budapest 1023, Hungary
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft., Budapest 1036, Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft., Budapest 1036, Hungary
Csolnoky Ferenc Korhaz, Veszprem H-8200, Hungary
Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of
Hanyang University Hospital, Seoul 133-792, Korea, Republic of
Leiden University Medical Center, Reumatologie, Leiden 2333 ZA, Netherlands
Rheumatology Research Institute of Russian Academy of Medical Sciences, Moscow 115522, Russian Federation
Russian Cardiology Research-and-Production Complex, Moscow 121552, Russian Federation
Clinical Rheumatological Hospital #25, Saint-Petersburg 190068, Russian Federation
Leningrad Regional Clinical Hospital, Saint-Petersburg 194291, Russian Federation
Limited Liability Company NMC Tomography, Saint-Petersburg 191014, Russian Federation
Hospital Reina Sofia, Cordoba 14004, Spain
Complexo Hospitalario Universitario A Coruña, La Coruña 15006, Spain
Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan
Chung Shan Medical University Hospital, Taichung 40201, Taiwan
Taipei Veterans General Hospital, Taipei 112, Taiwan
Rhuematology Clinical Research Unit, Cambridge CB2 0QQ, United Kingdom
Whipps Cross University Hospital,, London E11 1NR, United Kingdom
Hospital Virgen Macarena, Sevilla, Andalucia 41009, Spain
Preventive Care Ltda., Chia, Cundinamarca 0000, Colombia
Kenezy Gyula Korhaz, Debrecen, Hajdú-Bihar 4031, Hungary
Hampshire Hospitals NHS Foundation Trust, Basingstoke, Hants. RG24 9NA, United Kingdom
Gachon University Gil Hospital, Namdong-Gu, Incheon Gwangyeogsiv 405-760, Korea, Republic of
Fundacion Hospital Alcorcon, Alcorcon, Madrid 28922, Spain
Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology, Amsterdam, Noord-Holland 1105 AZ, Netherlands
Norfolk and Norwich University Hospital NHS Trust, Norwich, Norfolk NR4 7UY, United Kingdom
Ips Medicity S.A.S, Bucaramanga, Santander 68001000, Colombia
Servimed E.U, Bucaramanga, Santander 0000, Colombia
Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Tucuman T4000AXL, Argentina
Department of Rheumatology, Dudley, West Midlands DY1 2HQ, United Kingdom