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Etanercept Withdrawal And Retreatment Study In Subjects With Non- Radiographic Axial Spondyloarthritis (Chronic Lower Back Pain)

NCT02509026

Study Description

The purpose of this study is to investigate the efficacy and the safety of etanercept following withdrawal of etanercept in patients who have achieved a significant clinical response during the first period of the study.

Interventional
B1801381
NCT02509026
Recruiting
September, 2015
November, 2019

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Criteria

Key Inclusion Criteria: 

  • Male or female 18 to 49 years of age.
    • Diagnosis of axial SpA duration of symptoms more than 3 months and less than 5 years back pain with a less than favorable response to NSAIDs.
    • Back pain with a less than favorable response to current intake of an NSAID.
  • Ability to self-inject investigational product or have a designee who can do so. 

Key Exclusion Criteria:

  • Any previous treatment with a tumor necrosis factor-alpha inhibitor, B/T cell inhibitor or other biologic or immunosuppressive agent for a condition other than IBD.
    • Known or suspected allergy, hypersensitivity, or contraindication to etanercept.
  • Pregnant or breastfeeding; male participants with partners currently pregnant; fertile participants unwilling to use highly effective methods of contraception for the duration of the study and for 28 days after the last dose of the investigational study drug.
Both
18 Years - 49 Years
No
United States
Recruiting
Gulf Region Clinical Research Institute
Pensacola, Florida, United States, 32514
Terminated
Northwestern Medical Group; Division of Rheumatology
Chicago, Illinois, United States, 60611
Terminated
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Terminated
Northwestern University Clinical and Translational Sciences Institute (NUCATS)
Chicago, Illinois, United States, 60611
Terminated
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, United States, 11501
Recruiting
Oregon Health and Science University
Portland, Oregon, United States, 97239
Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Recruiting
Penn State Milton S. Hershey Medical Center - Drug Shipment Address
Hershey, Pennsylvania, United States, 17033
Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Recruiting
Swedish Medical Center Investigational Drug Services Pharmacy
Seattle, Washington, United States, 98 104
Recruiting
Seattle Rheumatology Associates
Seattle, Washington, United States, 98122
Recruiting
Swedish Medical Center
Seattle, Washington, United States, 98122
Australia
Recruiting
Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, Australia, 2292
Recruiting
Hunter Imaging Group
Cardiff, New South Wales, Australia, 2285
Recruiting
Pacific Radiology
Maroochydore, Queensland, Australia, 4558
Recruiting
Rheumatology Research Unit
Maroochydore, Queensland, Australia, 4558
Recruiting
Benson Radiology
North Adelaide, South Australia, Australia, 5006
Recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Recruiting
SKG Radiology Hollywood Hospital
Nedlands, Western Australia, Australia, 6009
Recruiting
SKG Radiology Subiaco
Subiaco, Western Australia, Australia, 6008
Recruiting
R.K. Will Pty Ltd
Victoria Park, Western Australia, Australia, 6100
Belgium
Recruiting
Private Practice Rheumatology
Sint-Niklaas, OVL, Belgium, 9100
Recruiting
Reumaclinic
Genk, Belgium, 3600
Colombia
Recruiting
Centro Integral de Reumatologia Reumalab S.A.S.
Medellin, Antioquia, Colombia, 05001000
Recruiting
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia, 050034
Recruiting
Preventive Care SAS
Chía, Cundinamarca, Colombia, 250001
Czechia
Recruiting
Affidea Praha s.r.o.
Praha 11, Czechia, 148 00
Recruiting
Revmatologicky ustav
Praha 2, Czechia, 128 50
Recruiting
Lekarna Hradebni s.r.o. "Drug shipment only"
Uherske Hradiste, Czechia, 686 01
Recruiting
MEDICAL PLUS, s.r.o.
Uherske Hradiste, Czechia, 686 01
Recruiting
Uherskohradist' ska nemocnice a.s.
Uherske Hradiste, Czechia, 686 68
Finland
Recruiting
Helsinki University Hospital
Helsinki, Finland, 00290
Recruiting
HYKS, Meilahden kolmiosairaala
Helsinki, Finland, 00290
Recruiting
Kiljavan Laeaeketutkimus Oy
Hyvinkaeae, Finland, 05800
France
Recruiting
CHU de Nancy - Hopital Central
Nancy, France, 54000
Recruiting
Hopital Cochin Pavillon Hardy B4
Paris, France, 75014
Recruiting
Pharmacie-Secteur Essais cliniques
Paris, France, 75014
Recruiting
CHU de Rennes, Hopital Sud
Rennes, France, 35000
Recruiting
Service Pharmacie-Sceteur essais cliniques
Rennes, France, 35200
Not yet recruiting
CHU PURPAN, Hopital Pierre-Paul Riquet
Toulouse cedex 9, France, 31059
Not yet recruiting
Pharmacie
Toulouse cedex 9, France, 31059
Recruiting
Pharmacie Essais cliniques (drug shipment only)
Vandoeuvre les Nancy, France, 54511 cedex
Recruiting
CHU de Nancy - Hopital de Brabois
Vandoeuvre-les-Nancy cedex, France, 54511
Germany
Recruiting
Medizinische Klinik und Poliklinik IV
Muenchen, Bavaria, Germany, 80336
Recruiting
Charité Universitaetsmedizin Berlin
Berlin, Charitéplatz 1, Germany, 10117
Recruiting
Charité Universitaetsmedizin Berlin
Berlin, Germany, 10117
Terminated
Apotheke am Tierpark
Berlin, Germany, 10315
Recruiting
Charité Universitaetmedizin Berlin
Berlin, Germany, 12203
Terminated
Praxis für radiologische Diagnostik
Berlin, Germany, 13055
Terminated
Rheumatologische Schwerpunktpraxis
Berlin, Germany, 13055
Recruiting
Schlosspark-Klinik GmbH
Berlin, Germany, 14059
Recruiting
Mvz Agilomed
Chemnitz, Germany, 09130
Not yet recruiting
Hamburger Rheuma Forschungszentrum I
Hamburg, Germany, 22391
Recruiting
Rheumazentrum Ruhrgebiet
Herne, Germany, 44649
Hungary
Recruiting
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest, Hungary, 1036
Terminated
VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
Veszprem, Hungary, 8200
Netherlands
Recruiting
READE
Amsterdam, Netherlands, 1056 AB
Recruiting
LUMC
Leiden, Netherlands, 2333 ZA
Poland
Not yet recruiting
Nzoz McD Voxel
Bydgoszcz, Poland, 85-015
Not yet recruiting
Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, Poland, 85-168
Not yet recruiting
Zaklad Radiologii i Diagnostyki Obrazowej
Bydgoszcz, Poland, 85-168
Recruiting
Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, Poland, 82-300
Not yet recruiting
Samodzielny Publiczny Zespol Opieki Zdrowotnej
Koscian, Poland, 64-000
Recruiting
Zespol Poradni Specjalistycznych REUMED, Filia nr 1
Lublin, Poland, 20-607
Not yet recruiting
Diagnostic-Med Centrum Diagnostyki Radiologicznej
Poznan, Poland, 61-545
Recruiting
SANUS Szpital Specjalistyczny Sp. z o.o.
Stalowa Wola, Poland, 37-450
Recruiting
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz"
Torun, Poland, 87-100
Recruiting
Medycyna Kliniczna
Warszawa, Poland, 00-660
Recruiting
Reumatika-Centrum Reumatologii NZOZ
Warszawa, Poland, 02-691
Recruiting
Centrum Medyczne OPOROW
Wrocław, Poland, 52-416
Spain
Recruiting
Hospital Universitario de Canarias
San Cristobal de la Laguna, Santa Cruz de Tenerife, Spain, 38320
Recruiting
Complexo Hospitalario Universitario A Coruna
A Coruna, Spain, 15006
Recruiting
Hospital San Rafael
A Coruna, Spain, 15006
Recruiting
Complejo Hospitalario Regional Virgen Macarena
Sevilla, Spain, 41009
Sweden
Recruiting
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Recruiting
Skanes University Hospital Malmo-Lund
Malmo, Sweden, 205 02
Recruiting
Akademiska sjukhuset
Uppsala, Sweden, 751 85
Taiwan
Recruiting
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 80756
Recruiting
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Recruiting
Chung Shan Medical University
Taichung, Taiwan, 40201
Recruiting
China Medical University Hospital
Taichung, Taiwan, 40447