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

Condition(s) targeted: Spondylitis, Ankylosing

Intervention: etanercept (Biological); Background NSAID (Drug); PLACEBO (Other); Background NSAID (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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).

Official title: A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study of Etanercept on a Background Non Steroidal Anti-Inflammatory Drug in the Treatment of Adult Subjects With Non Radiographic Axial Spondyloarthritis With a 92 Week Open Label Extension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12.

Secondary outcome:

Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 40 at time points other than 12 weeks and over time

Proportion 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.

Criteria:

Inclusion Criteria:

- Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing

Spondylitis (ASAS)criteria

- Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or

= 4

- Axial symptoms of back pain with a less than favorable response to on steroidal anti

inflammatory drugs at optimal dosage for greater than 4 weeks

Exclusion Criteria:

- Evidence of current or recent episode of uveitis

- Evidence of IBD flare within 6 months

- Previous treatment with an anti Tumor necrosis factor(TNF)

- Active tuberculosis

- Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Consultorios Reumatológicos Pampa, Buenos Aires C1428DZF, Argentina; Active, not recruiting

Universitair Ziekenhuis Gent, Gent 9000, Belgium; Active, not recruiting

Reuma Instituut, Hasselt 3500, Belgium; Active, not recruiting

AZ Groeninge, Kortrijk 8500, Belgium; Active, not recruiting

Medicity S.A.S, Bucaramanga 0000, Colombia; Active, not recruiting

Mediscan Group s.r.o., Praha 11 - Chodov 14800, Czech Republic; Active, not recruiting

Revmatologicky ustav, Praha 2 128 50, Czech Republic; Active, not recruiting

Medical Plus s.r.o., Uherske Hradiste 68601, Czech Republic; Recruiting

Helsingin yliopistollinen keskussairaala, Reumatologian klinikka, Helsinki 00290, Finland; Terminated

Kiljavan Lääketutkimus Oy, Hyvinkää 05800, Finland; Active, not recruiting

Hopital Bicetre, LE KREMLIN-BICETRE Cedex 94275, France; Active, not recruiting

CHU Lapeyronie, Immuno-Rhumatologie, Montpellier 34000, France; Active, not recruiting

Hôpital Cochin, Paris 75014, France; Active, not recruiting

CHU de Tours, Tours Cedex 9 37044, France; Active, not recruiting

Charite - Campus Benjamin Franklin, Medizinische Klink I - Rheumatologie, Berlin 12203, Germany; Active, not recruiting

Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen, Erlangen 91054, Germany; Active, not recruiting

Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie, Hamburg 22081, Germany; Active, not recruiting

St. Josefs-Krankenhaus, Rheumazentrum Ruhrgebiet, Herne 44652, Germany; Active, not recruiting

MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH, Vogelsang-Gommern 39245, Germany; Active, not recruiting

Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly, Budapest 1023, Hungary; Active, not recruiting

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft., Budapest 1036, Hungary; Active, not recruiting

Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft., Budapest 1036, Hungary; Active, not recruiting

Budai Irgalmasrendi Korhaz, Reumatologia I., Budapest 1027, Hungary; Active, not recruiting

Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Kft./Reumatologiai Osztaly, Debrecen 4043, Hungary; Active, not recruiting

Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt./Reumatologia es mozgasszervi rehab. Centrum, Veszprem 8200, Hungary; Active, not recruiting

Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of; Active, not recruiting

Gachon University Gil Hospital, Incheon 405-760, Korea, Republic of; Active, not recruiting

Hanyang University Hospital, Seoul 133-792, Korea, Republic of; Active, not recruiting

Leiden University Medical Center, Reumatologie, Leiden 2333 ZA, Netherlands; Active, not recruiting

Rheumatology Research Institute of Russian Academy of Medical Sciences, Moscow 115522, Russian Federation; Terminated

Russian Cardiology Research-and-Production Complex, Moscow 121552, Russian Federation; Terminated

Limited Liability Company NMC Tomography, Saint-Petersburg 191014, Russian Federation; Terminated

Clinical Rheumatological Hospital #25, Saint-Petersburg 190068, Russian Federation; Terminated

Leningrad Regional Clinical Hospital, Saint-Petersburg 194291, Russian Federation; Active, not recruiting

Hospital Reina Sofia, Cordoba 14004, Spain; Terminated

Complexo Hospitalario Universitario A Coruña, La Coruña 15006, Spain; Active, not recruiting

Hospital Virgen Macarena, Sevilla 41009, Spain; Active, not recruiting

Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan; Active, not recruiting

Chung Shan Medical University Hospital, Taichung 402, Taiwan; Active, not recruiting

Taipei Veterans General Hospital, Taipei 112, Taiwan; Active, not recruiting

Rhuematology Clinical Research Unit, Cambridge CB2 0QQ, United Kingdom; Active, not recruiting

Department of Rheumatology, Dudley, West Midlands DY1 2HQ, United Kingdom; Active, not recruiting

Whipps Cross University Hospital,, London E11 1NR, United Kingdom; Active, not recruiting

Preventive Care Ltda., Chia, Cundinamarca 0000, Colombia; Active, not recruiting

Hampshire Hospitals NHS Foundation Trust, Basingstoke, Hants. RG24 9NA, United Kingdom; Terminated

Fundacion Hospital Alcorcon, Alcorcon, Madrid 28922, Spain; Terminated

Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology, Amsterdam, Noord-Holland 1105 AZ, Netherlands; Active, not recruiting

Norfolk and Norwich University Hospital NHS Trust, Norwich, Norfolk NR4 7UY, United Kingdom; Active, not recruiting

Servimed E.U, Bucaramanga, Santander 0000, Colombia; Active, not recruiting

Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Tucuman T4000AXL, Argentina; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: February 2011
Last updated: January 16, 2013