Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
NCT ID: NCT02509026
Last Updated: 2020-06-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2015-09-24
2019-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etanercept
etanercept 50 mg QW
Etanercept
50 mg subcutaneous, once weekly, 24 weeks
Interventions
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Etanercept
50 mg subcutaneous, once weekly, 24 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Gulf Region Clinical Research Institute
Pensacola, Florida, United States
Northwestern Medical Group; Division of Rheumatology
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University Clinical and Translational Sciences Institute (NUCATS)
Chicago, Illinois, United States
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, United States
Oregon Health and Science University Research Pharmacy
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Swedish Medical Center Investigational Drug Services Pharmacy
Seattle, Washington, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, Australia
Hunter Imaging Group
Cardiff, New South Wales, Australia
Pacific Radiology
Maroochydore, Queensland, Australia
Rheumatology Research Centre
Maroochydore, Queensland, Australia
Benson Radiology
North Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
SKG Radiology Hollywood Hospital
Nedlands, Western Australia, Australia
SKG Radiology Subiaco
Subiaco, Western Australia, Australia
R.K. Will Pty Ltd
Victoria Park, Western Australia, Australia
Private Practice Rheumatology
Sint-Niklaas, OVL, Belgium
Reumaclinic
Genk, , Belgium
Centro Integral de Reumatologia Reumalab S.A.S.
Medellín, Antioquia, Colombia
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Preventive Care SAS
Chía, Cundinamarca, Colombia
Revmatologicky ustav
Prague, , Czechia
Affidea Praha s.r.o.
Prague, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
Uherskohradist' ska nemocnice a.s.
Uherské Hradiště, , Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště, , Czechia
Helsinki University Hospital
Helsinki, , Finland
HYKS, Meilahden kolmiosairaala
Helsinki, , Finland
Kiljavan Laaketutkimus Oy
Hyvinkää, , Finland
Service d'Imagerie Guilloz
Nancy, , France
Hopital Cochin Pavillon Hardy B4
Paris, , France
Pharmacie-Secteur Essais cliniques
Paris, , France
CHU de Rennes, Hopital Sud
Rennes, , France
CHU PURPAN, Hopital Pierre-Paul Riquet
Toulouse, , France
Pharmacie
Toulouse, , France
Pharmacie Essais cliniques
Vandœuvre-lès-Nancy, , France
CHU de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, , France
Medizinische Klinik und Poliklinik IV
Munich, Bavaria, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, Germany
Charité Universitaetsmedizin Berlin
Berlin, , Germany
Apotheke am Tierpark
Berlin, , Germany
Charité Universitaetsmedizin Berlin
Berlin, , Germany
Praxis für radiologische Diagnostik
Berlin, , Germany
Rheumatologische Schwerpunktpraxis
Berlin, , Germany
Schlosspark-Klinik GmbH
Berlin, , Germany
Mvz Agilomed
Chemnitz, , Germany
Universitaetskliniken Koeln
Cologne, , Germany
Qualiclinic Kft.
Budapest, , Hungary
VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
Veszprém, , Hungary
READE
Amsterdam, , Netherlands
LUMC
Leiden, , Netherlands
Nzoz McD Voxel
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, , Poland
Zaklad Radiologii i Diagnostyki Obrazowej
Bydgoszcz, , Poland
Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Samodzielny Publiczny Zespol Opieki Zdrowotnej
Kościan, , Poland
Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1
Lublin, , Poland
RCMed
Nowy Duninów, , Poland
Diagnostic-Med Centrum Diagnostyki Radiologicznej
Poznan, , Poland
RCMed
Sochaczew, , Poland
SANUS Szpital Specjalistyczny Sp. z o.o.
Stalowa Wola, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Reumatika-Centrum Reumatologii NZOZ
Warsaw, , Poland
Centrum Medyczne OPOROW
Wroclaw, , Poland
Complejo Hospitalario Universitario Santiago
Santiago de Compostela, A Coruna, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital San Rafael
A Coruña, , Spain
Complejo Hospitalario Regional Virgen Macarena
Seville, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skanes University Hospital Malmo
Malmo, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Chung Shan Medical University
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Countries
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References
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Van den Bosch F, Wei JC, Nash P, Blanco FJ, Graham D, Zang C, Arthur E, Borlenghi C, Tsekouras V, Vlahos B, Deodhar A. Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial. J Rheumatol. 2023 Apr;50(4):478-487. doi: 10.3899/jrheum.220353. Epub 2022 Nov 15.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2015-000541-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1801381
Identifier Type: -
Identifier Source: org_study_id
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