Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
RE-EMBARK
A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
2 other identifiers
interventional
210
14 countries
82
Brief Summary
The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2015
Longer than P75 for phase_4
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2015
CompletedFirst Posted
Study publicly available on registry
July 27, 2015
CompletedStudy Start
First participant enrolled
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2019
CompletedResults Posted
Study results publicly available
June 16, 2020
CompletedJune 16, 2020
June 1, 2020
3.7 years
July 21, 2015
May 7, 2020
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment
Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of \>=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawal of Etanercept treatment of 24 weeks in Induction period are reported in this outcome measure.
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Secondary Outcomes (189)
Time to Flare Following Withdrawal of Etanercept Treatment
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 28, 32, 40, 48, 56, 64
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3
Week 68, 72, 76
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
- +184 more secondary outcomes
Study Arms (1)
Etanercept
EXPERIMENTALetanercept 50 mg QW
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of axial SpA duration of symptoms \>3 months and \<5 years back pain with a less than favorable response to NSAIDs
You may not qualify if:
- radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (82)
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514, United States
Northwestern Medical Group; Division of Rheumatology
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Northwestern University Clinical and Translational Sciences Institute (NUCATS)
Chicago, Illinois, 60611, United States
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, 11501, United States
Oregon Health and Science University Research Pharmacy
Portland, Oregon, 97239, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Swedish Medical Center Investigational Drug Services Pharmacy
Seattle, Washington, 98 104, United States
Seattle Rheumatology Associates
Seattle, Washington, 98122, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, 2292, Australia
Hunter Imaging Group
Cardiff, New South Wales, 2285, Australia
Pacific Radiology
Maroochydore, Queensland, 4558, Australia
Rheumatology Research Centre
Maroochydore, Queensland, 4558, Australia
Benson Radiology
North Adelaide, South Australia, 5006, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
SKG Radiology Hollywood Hospital
Nedlands, Western Australia, 6009, Australia
SKG Radiology Subiaco
Subiaco, Western Australia, 6008, Australia
R.K. Will Pty Ltd
Victoria Park, Western Australia, 6100, Australia
Private Practice Rheumatology
Sint-Niklaas, OVL, 9100, Belgium
Reumaclinic
Genk, 3600, Belgium
Centro Integral de Reumatologia Reumalab S.A.S.
Medellín, Antioquia, 050010, Colombia
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 050034, Colombia
Preventive Care SAS
Chía, Cundinamarca, 250001, Colombia
Revmatologicky ustav
Prague, 128 50, Czechia
Affidea Praha s.r.o.
Prague, 148 00, Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, 686 01, Czechia
Uherskohradist' ska nemocnice a.s.
Uherské Hradiště, 686 68, Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště, 68601, Czechia
Helsinki University Hospital
Helsinki, 00290, Finland
HYKS, Meilahden kolmiosairaala
Helsinki, 00290, Finland
Kiljavan Laaketutkimus Oy
Hyvinkää, 05800, Finland
Service d'Imagerie Guilloz
Nancy, 54000, France
Hopital Cochin Pavillon Hardy B4
Paris, 75014, France
Pharmacie-Secteur Essais cliniques
Paris, 75014, France
CHU de Rennes, Hopital Sud
Rennes, 35000, France
CHU PURPAN, Hopital Pierre-Paul Riquet
Toulouse, 31059, France
Pharmacie
Toulouse, 31059, France
Pharmacie Essais cliniques
Vandœuvre-lès-Nancy, 54511 cedex, France
CHU de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54511, France
Medizinische Klinik und Poliklinik IV
Munich, Bavaria, 80336, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, 44649, Germany
Charité Universitaetsmedizin Berlin
Berlin, 10117, Germany
Apotheke am Tierpark
Berlin, 10315, Germany
Charité Universitaetsmedizin Berlin
Berlin, 12203, Germany
Praxis für radiologische Diagnostik
Berlin, 13055, Germany
Rheumatologische Schwerpunktpraxis
Berlin, 13055, Germany
Schlosspark-Klinik GmbH
Berlin, 14059, Germany
Mvz Agilomed
Chemnitz, 09130, Germany
Universitaetskliniken Koeln
Cologne, 50937, Germany
Qualiclinic Kft.
Budapest, 1036, Hungary
VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
Veszprém, 8200, Hungary
READE
Amsterdam, 1056 AB, Netherlands
LUMC
Leiden, 2333 ZA, Netherlands
Nzoz McD Voxel
Bydgoszcz, 85-015, Poland
Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, 85-168, Poland
Zaklad Radiologii i Diagnostyki Obrazowej
Bydgoszcz, 85-168, Poland
Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, 82-300, Poland
Samodzielny Publiczny Zespol Opieki Zdrowotnej
Kościan, 64-000, Poland
Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1
Lublin, 20-607, Poland
RCMed
Nowy Duninów, 09-505, Poland
Diagnostic-Med Centrum Diagnostyki Radiologicznej
Poznan, 61-545, Poland
RCMed
Sochaczew, 96-500, Poland
SANUS Szpital Specjalistyczny Sp. z o.o.
Stalowa Wola, 37-450, Poland
Nasz Lekarz Przychodnie Medyczne
Torun, 87-100, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
Reumatika-Centrum Reumatologii NZOZ
Warsaw, 02-691, Poland
Centrum Medyczne OPOROW
Wroclaw, 52-416, Poland
Complejo Hospitalario Universitario Santiago
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital San Rafael
A Coruña, 15009, Spain
Complejo Hospitalario Regional Virgen Macarena
Seville, 41009, Spain
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Skanes University Hospital Malmo
Malmo, 205 02, Sweden
Akademiska sjukhuset
Uppsala, 751 85, Sweden
Kaohsiung Medical University Hospital
Kaohsiung City, 80756, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Chung Shan Medical University
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Related Publications (1)
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.
PMID: 36379575DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2015
First Posted
July 27, 2015
Study Start
September 24, 2015
Primary Completion
May 28, 2019
Study Completion
September 6, 2019
Last Updated
June 16, 2020
Results First Posted
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.