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
NCT ID: NCT01258738
Last Updated: 2015-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2011-02-28
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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etanercept
In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly 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.
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.
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.
PLACEBO
In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
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.
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).
Interventions
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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.
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.
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
18 Years
49 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Consultorios Reumatológicos Pampa
Buenos Aires, , Argentina
Universitair Ziekenhuis Gent
Ghent, , Belgium
Reuma Instituut
Hasselt, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Preventive Care Ltda.
Chía, Cundinamarca, Colombia
Ips Medicity S.A.S
Bucaramanga, Santander Department, Colombia
Servimed Sas
Bucaramanga, Santander Department, Colombia
Revmatologicky ustav
Prague, , Czechia
Mediscan Group, s.r.o.
Praha 11 - Chodov, , Czechia
Medical Plus s.r.o.
Uherské Hradiště, , Czechia
Meilahden kolmiosairaala
Helsinki, , Finland
Kiljavan Lääketutkimus
Hyvinkää, , Finland
Hopital de Bicetre
Le Kremlin-Bicêtre, , France
CHU Lapeyronie, Immuno-Rhumatologie
Montpellier, , France
Hôpital Cochin
Paris, , France
CHU de Tours
Tours, , France
Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie
Berlin, , Germany
Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen
Erlangen, , Germany
Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH
Vogelsang-Gommern, , Germany
Budai Irgalmasrendi Korhaz
Budapest, Budapest, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly
Budapest, , Hungary
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.
Budapest, , Hungary
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, , Hungary
Csolnoky Ferenc Korhaz
Veszprém, , Hungary
Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology
Amsterdam, North Holland, Netherlands
Leiden University Medical Center, Reumatologie
Leiden, , Netherlands
Rheumatology Research Institute of Russian Academy of Medical Sciences
Moscow, , Russia
Russian Cardiology Research-and-Production Complex
Moscow, , Russia
Saint-Petersburg State Budgetary Healthcare Institution
Saint Petersburg, , Russia
Limited Liability Company NMC Tomography
Saint Petersburg, , Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Gachon University Gil Hospital
Incheon, Gwangyeogsiv, South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Hospital Virgen Macarena
Seville, Andalusia, Spain
Hospital Reina Sofia
Córdoba, Cordoba, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Fundacion Hospital Alcorcon
Alcorcón, Madrid, Spain
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Rhuematology Clinical Research Unit
Cambridge, Cambridgeshire, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hants., United Kingdom
Norfolk and Norwich University Hospital NHS Trust
Norwich, Norfolk, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
Whipps Cross University Hospital,
London, , United Kingdom
Countries
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References
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Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Erosions on T1-Weighted Magnetic Resonance Imaging Versus Radiography of Sacroiliac Joints in Recent-Onset Axial Spondyloarthritis: 2-Year Data (EMBARK Trial and DESIR Cohort). J Rheumatol. 2024 May 1;51(5):462-471. doi: 10.3899/jrheum.2023-0906.
Schneeberger EE, Citera G, de Leon DP, Szumski AE, Kwok K, Cutri M, Dougados M. Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) Versus ASDAS: A Post Hoc Analysis of a Randomized Controlled Trial. J Rheumatol. 2022 Oct;49(10):1100-1108. doi: 10.3899/jrheum.211075. Epub 2022 Jul 15.
Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.
Dougados M, van der Heijde D, Tsai WC, Saaibi D, Marshall L, Jones H, Pedersen R, Vlahos B, Tarallo M. Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study. Health Qual Life Outcomes. 2020 Jan 3;18(1):4. doi: 10.1186/s12955-019-1260-4.
Dougados M, Maksymowych WP, Landewe RBM, Molto A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.
Maksymowych WP, Wichuk S, Dougados M, Jones HE, Pedersen R, Szumski A, Marshall L, Bukowski JF, Lambert RG. Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2018 Jan;77(1):78-84. doi: 10.1136/annrheumdis-2017-211605. Epub 2017 Sep 29.
Brown MA, Bird PA, Robinson PC, Mease PJ, Bosch FVD, Surian C, Jones H, Szumski A, Marshall L, Wiid Z, Dougados M. Evaluation of the effect of baseline MRI sacroiliitis and C reactive protein status on etanercept treatment response in non-radiographic axial spondyloarthritis: a post hoc analysis of the EMBARK study. Ann Rheum Dis. 2018 Jul;77(7):1091-1093. doi: 10.1136/annrheumdis-2017-211313. Epub 2017 Jul 3. No abstract available.
Maksymowych WP, Wichuk S, Dougados M, Jones H, Szumski A, Bukowski JF, Marshall L, Lambert RG. MRI evidence of structural changes in the sacroiliac joints of patients with non-radiographic axial spondyloarthritis even in the absence of MRI inflammation. Arthritis Res Ther. 2017 Jun 6;19(1):126. doi: 10.1186/s13075-017-1342-9.
Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Lenaerts J, van den Bosch F, Wei JC, Pedersen R, Bonin R, Jones H, Marshall L, Logeart I, Vlahos B, Bukowski JF, Maksymowych WP. Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1590-1598. doi: 10.1002/acr.23276. Epub 2017 Aug 31.
Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, Marshall L, Bonin R, Pedersen R, Vlahos B, Kotak S, Bukowski JF. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.
Dougados M, van der Heijde D, Sieper J, Braun J, Maksymowych WP, Citera G, Miceli-Richard C, Wei JC, Pedersen R, Bonin R, Rahman MU, Logeart I, Wajdula J, Koenig AS, Vlahos B, Alvarez D, Bukowski JF. Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2014 Aug;66(8):2091-102. doi: 10.1002/art.38721.
Related Links
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Other Identifiers
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0881A3-4725
Identifier Type: OTHER
Identifier Source: secondary_id
2010-020077-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1801031
Identifier Type: -
Identifier Source: org_study_id
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