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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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-24

Study Completion Date

2019-09-06

Brief Summary

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The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

Detailed Description

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This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment.

Conditions

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Spondylitis, Ankylosing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept

etanercept 50 mg QW

Group Type EXPERIMENTAL

Etanercept

Intervention Type BIOLOGICAL

50 mg subcutaneous, once weekly, 24 weeks

Interventions

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Etanercept

50 mg subcutaneous, once weekly, 24 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of axial SpA duration of symptoms \>3 months and \<5 years back pain with a less than favorable response to NSAIDs

Exclusion Criteria

* radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Northwestern Medical Group; Division of Rheumatology

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Northwestern University Clinical and Translational Sciences Institute (NUCATS)

Chicago, Illinois, United States

Site Status

Winthrop University Hospital, Clinical Trials Center

Mineola, New York, United States

Site Status

Oregon Health and Science University Research Pharmacy

Portland, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Swedish Medical Center Investigational Drug Services Pharmacy

Seattle, Washington, United States

Site Status

Seattle Rheumatology Associates

Seattle, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Genesis Research Services Pty Ltd

Broadmeadow, New South Wales, Australia

Site Status

Hunter Imaging Group

Cardiff, New South Wales, Australia

Site Status

Pacific Radiology

Maroochydore, Queensland, Australia

Site Status

Rheumatology Research Centre

Maroochydore, Queensland, Australia

Site Status

Benson Radiology

North Adelaide, South Australia, Australia

Site Status

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Site Status

SKG Radiology Hollywood Hospital

Nedlands, Western Australia, Australia

Site Status

SKG Radiology Subiaco

Subiaco, Western Australia, Australia

Site Status

R.K. Will Pty Ltd

Victoria Park, Western Australia, Australia

Site Status

Private Practice Rheumatology

Sint-Niklaas, OVL, Belgium

Site Status

Reumaclinic

Genk, , Belgium

Site Status

Centro Integral de Reumatologia Reumalab S.A.S.

Medellín, Antioquia, Colombia

Site Status

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Site Status

Preventive Care SAS

Chía, Cundinamarca, Colombia

Site Status

Revmatologicky ustav

Prague, , Czechia

Site Status

Affidea Praha s.r.o.

Prague, , Czechia

Site Status

MEDICAL PLUS, s.r.o.

Uherské Hradiště, , Czechia

Site Status

Uherskohradist' ska nemocnice a.s.

Uherské Hradiště, , Czechia

Site Status

Lekarna Hradebni s.r.o.

Uherské Hradiště, , Czechia

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

HYKS, Meilahden kolmiosairaala

Helsinki, , Finland

Site Status

Kiljavan Laaketutkimus Oy

Hyvinkää, , Finland

Site Status

Service d'Imagerie Guilloz

Nancy, , France

Site Status

Hopital Cochin Pavillon Hardy B4

Paris, , France

Site Status

Pharmacie-Secteur Essais cliniques

Paris, , France

Site Status

CHU de Rennes, Hopital Sud

Rennes, , France

Site Status

CHU PURPAN, Hopital Pierre-Paul Riquet

Toulouse, , France

Site Status

Pharmacie

Toulouse, , France

Site Status

Pharmacie Essais cliniques

Vandœuvre-lès-Nancy, , France

Site Status

CHU de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Medizinische Klinik und Poliklinik IV

Munich, Bavaria, Germany

Site Status

Rheumazentrum Ruhrgebiet

Herne, North Rhine-Westphalia, Germany

Site Status

Charité Universitaetsmedizin Berlin

Berlin, , Germany

Site Status

Apotheke am Tierpark

Berlin, , Germany

Site Status

Charité Universitaetsmedizin Berlin

Berlin, , Germany

Site Status

Praxis für radiologische Diagnostik

Berlin, , Germany

Site Status

Rheumatologische Schwerpunktpraxis

Berlin, , Germany

Site Status

Schlosspark-Klinik GmbH

Berlin, , Germany

Site Status

Mvz Agilomed

Chemnitz, , Germany

Site Status

Universitaetskliniken Koeln

Cologne, , Germany

Site Status

Qualiclinic Kft.

Budapest, , Hungary

Site Status

VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

Veszprém, , Hungary

Site Status

READE

Amsterdam, , Netherlands

Site Status

LUMC

Leiden, , Netherlands

Site Status

Nzoz McD Voxel

Bydgoszcz, , Poland

Site Status

Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob

Bydgoszcz, , Poland

Site Status

Zaklad Radiologii i Diagnostyki Obrazowej

Bydgoszcz, , Poland

Site Status

Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

Elblag, , Poland

Site Status

Samodzielny Publiczny Zespol Opieki Zdrowotnej

Kościan, , Poland

Site Status

Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1

Lublin, , Poland

Site Status

RCMed

Nowy Duninów, , Poland

Site Status

Diagnostic-Med Centrum Diagnostyki Radiologicznej

Poznan, , Poland

Site Status

RCMed

Sochaczew, , Poland

Site Status

SANUS Szpital Specjalistyczny Sp. z o.o.

Stalowa Wola, , Poland

Site Status

Nasz Lekarz Przychodnie Medyczne

Torun, , Poland

Site Status

Medycyna Kliniczna

Warsaw, , Poland

Site Status

Reumatika-Centrum Reumatologii NZOZ

Warsaw, , Poland

Site Status

Centrum Medyczne OPOROW

Wroclaw, , Poland

Site Status

Complejo Hospitalario Universitario Santiago

Santiago de Compostela, A Coruna, Spain

Site Status

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain

Site Status

Complexo Hospitalario Universitario A Coruna

A Coruña, , Spain

Site Status

Hospital San Rafael

A Coruña, , Spain

Site Status

Complejo Hospitalario Regional Virgen Macarena

Seville, , Spain

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Skanes University Hospital Malmo

Malmo, , Sweden

Site Status

Akademiska sjukhuset

Uppsala, , Sweden

Site Status

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Chung Shan Medical University

Taichung, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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United States Australia Belgium Colombia Czechia Finland France Germany Hungary Netherlands Poland Spain Sweden Taiwan

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.

Reference Type DERIVED
PMID: 36379575 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

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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