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

NCT01258738 | Completed Phase 3 Results

• 3 other identifiers: B18010310881A3-47252010-020077-16
• Study Type: interventional
• Target: 225
• Locations: 14 countries
• Sites: 50

Brief Summary

This is a two part study. During period one there will be a comparison 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).

Conditions

Spondylitis, Ankylosing

Keywords

Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12

  ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

  Week 12

Secondary Outcomes (65)

• Percentage of Participants Achieving ASAS 40 Response at Time Points

  Baseline to Week 104

• Percentage of Participants Achieving ASAS 20 Response at Time Points

  Baseline to Week 104

• Percentage of Participants Achieving ASAS 5/6 Response at Time Points

  Baseline to Week 104

• Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points

  Baseline to Week 104

• Percentage of Participants Achieving ASAS Partial Remission at Time Points

  Baseline to Week 104

Study Arms (2)

etanercept

ACTIVE COMPARATOR

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.

Biological: etanercept; Drug: Background NSAID

PLACEBO

PLACEBO COMPARATOR

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.

Other: PLACEBO; Drug: Background NSAID

Interventions

etanercept BIOLOGICAL

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.

Also known as: ENBREL

etanercept

Background NSAID DRUG

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.

etanercept

PLACEBO OTHER

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (50)

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Consultorios Reumatológicos Pampa

Buenos Aires, C1428DZF, Argentina

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Reuma Instituut

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Preventive Care Ltda.

Chía, Cundinamarca, Colombia

Location

Ips Medicity S.A.S

Bucaramanga, Santander Department, Colombia

Location

Servimed Sas

Bucaramanga, Santander Department, Colombia

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Mediscan Group, s.r.o.

Praha 11 - Chodov, 14800, Czechia

Location

Medical Plus s.r.o.

Uherské Hradiště, 68601, Czechia

Location

Meilahden kolmiosairaala

Helsinki, 00029, Finland

Location

Kiljavan Lääketutkimus

Hyvinkää, 05800, Finland

Location

Hopital de Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

CHU Lapeyronie, Immuno-Rhumatologie

Montpellier, 34000, France

Location

Hôpital Cochin

Paris, 75014, France

Location

CHU de Tours

Tours, 37044, France

Location

Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie

Berlin, 12203, Germany

Location

Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

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

Hamburg, 22081, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH

Vogelsang-Gommern, 39245, Germany

Location

Budai Irgalmasrendi Korhaz

Budapest, Budapest, 1027, Hungary

Location

Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly

Budapest, 1023, Hungary

Location

Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

Budapest, 1036, Hungary

Location

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.

Budapest, 1036, Hungary

Location

Kenezy Gyula Korhaz es Rendelointezet

Debrecen, 4031, Hungary

Location

Csolnoky Ferenc Korhaz

Veszprém, 8200, Hungary

Location

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

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Leiden University Medical Center, Reumatologie

Leiden, 2333 ZA, Netherlands

Location

Rheumatology Research Institute of Russian Academy of Medical Sciences

Moscow, 115522, Russia

Location

Russian Cardiology Research-and-Production Complex

Moscow, 121552, Russia

Location

Saint-Petersburg State Budgetary Healthcare Institution

Saint Petersburg, 190068, Russia

Location

Limited Liability Company NMC Tomography

Saint Petersburg, 191014, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

Gachon University Gil Hospital

Incheon, Gwangyeogsiv, 405-760, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Hanyang University Hospital

Seoul, 133-792, South Korea

Location

Hospital Virgen Macarena

Seville, Andalusia, 41009, Spain

Location

Hospital Reina Sofia

Córdoba, Cordoba, 14004, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Fundacion Hospital Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Rhuematology Clinical Research Unit

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hants., RG24 9NA, United Kingdom

Location

Norfolk and Norwich University Hospital NHS Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Whipps Cross University Hospital,

London, E11 1NR, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 38359938 DERIVED

• 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.

  PMID: 35840157 DERIVED

• 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.

  PMID: 33514428 DERIVED

• 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.

  PMID: 31900174 DERIVED

• 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.

  PMID: 28970213 DERIVED

• 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.

  PMID: 28970212 DERIVED

• 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.

  PMID: 28673924 DERIVED

• 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.

  PMID: 28587658 DERIVED

• 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.

  PMID: 28482137 DERIVED

• 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.

  PMID: 26269397 DERIVED

• 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.

  PMID: 24891317 DERIVED

Related Links

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

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 13, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: October 1, 2014
• Last Updated: October 19, 2015
• Results First Posted: October 19, 2015

Record last verified: 2015-09

Locations

ES (4); BE (3); FI (2); AR (2); FR (4); GB (5); RU (5); KR (3); CO (3); CZ (3); HU (6); TW (3); NL (2); DE (5)