Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial
Introduction Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inf...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-06-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/6/e098298.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850118810001997824 |
|---|---|
| author | Bruno Fautrel Pascal Richette Christian Roux Grégoire Cormier Martin Soubrier Xavier Mariette Christophe Richez Jacques-Eric Gottenberg Hubert Marotte Jacques Morel Rene-Marc Flipo Jerome Avouac Athan Baillet Gael Mouterde Anne Tournadre Marie-Elise Truchetet Sebastien Ottaviani Tristan Pascart Thierry Lequerre Elisabeth Gervais Luca Semerano André Basch Edouard Pertuiset Jean-Hugues Salmon Eric Houvenagel VÉRONIQUE BREUIL Marie Vandecandelaere Olivier Vittecocq Isabelle Griffoul Charlotte Jauffret Vincent Ducoulombier Laurène Norberciak Jean-Guillaume Letarouilly Slim Lassoued Renaud Desbarbieux Hélène Luraschi Thibault Rabin Gauthier Marchasson Catherine Godart Nicolas Taisne |
| author_facet | Bruno Fautrel Pascal Richette Christian Roux Grégoire Cormier Martin Soubrier Xavier Mariette Christophe Richez Jacques-Eric Gottenberg Hubert Marotte Jacques Morel Rene-Marc Flipo Jerome Avouac Athan Baillet Gael Mouterde Anne Tournadre Marie-Elise Truchetet Sebastien Ottaviani Tristan Pascart Thierry Lequerre Elisabeth Gervais Luca Semerano André Basch Edouard Pertuiset Jean-Hugues Salmon Eric Houvenagel VÉRONIQUE BREUIL Marie Vandecandelaere Olivier Vittecocq Isabelle Griffoul Charlotte Jauffret Vincent Ducoulombier Laurène Norberciak Jean-Guillaume Letarouilly Slim Lassoued Renaud Desbarbieux Hélène Luraschi Thibault Rabin Gauthier Marchasson Catherine Godart Nicolas Taisne |
| collection | DOAJ |
| description | Introduction Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials. In case of TNFi inadequate response, using other mechanisms of action provides a better response than using an alternate TNFi. Which non-TNFi bDMARD administered subcutaneously to allow for ambulatory management to choose in case of first line TNFi inadequate response has not been tested in a randomised clinical trial, while observational data support a potential superiority of tocilizumab over abatacept.Methods and analysis The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI<10, no use of rescue treatment after week 12 and no experimental treatment change, at weeks 12, 24 and 52.Ethics and dissemination Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.Trial registration number NCT03227419 and EudraCT2017-000947-41. |
| format | Article |
| id | doaj-art-1621b47e38374751bfa78e227965ae3f |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-1621b47e38374751bfa78e227965ae3f2025-08-20T02:35:47ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-098298Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial Bruno Fautrel0Pascal RichetteChristian RouxGrégoire Cormier1Martin SoubrierXavier Mariette2Christophe Richez3Jacques-Eric Gottenberg4Hubert MarotteJacques Morel5Rene-Marc FlipoJerome Avouac6Athan BailletGael MouterdeAnne TournadreMarie-Elise Truchetet7Sebastien OttavianiTristan Pascart8Thierry LequerreElisabeth GervaisLuca SemeranoAndré Basch9Edouard PertuisetJean-Hugues SalmonEric Houvenagel10VÉRONIQUE BREUILMarie VandecandelaereOlivier VittecocqIsabelle GriffoulCharlotte JauffretVincent Ducoulombier11Laurène Norberciak12Jean-Guillaume LetarouillySlim LassouedRenaud DesbarbieuxHélène LuraschiThibault RabinGauthier MarchassonCatherine GodartNicolas TaisneRheumatology, Pitié-Salpêtrière University Hospital, Paris, Île-de-France, FranceRheumatology, Centre Hospitalier Departemental Vendee, La Roche-sur-Yon, FranceRheumatology, Hôpital Bicêtre, Le Kremlin-Bicetre, Île-de-France, FranceRheumatology, CHU Bordeaux GH Pellegrin, Bordeaux, Nouvelle-Aquitaine, FranceRheumatology, Hopitaux universitaires de Strasbourg, Strasbourg, FranceRheumatology, CHU de Montpellier, Montpellier, Occitanie, FranceUniversité Paris Cité UFR de Médecine Site Cochin, Paris, Île-de-France, FranceRheumatology, CHU Bordeaux GH Pellegrin, Bordeaux, Nouvelle-Aquitaine, FranceDepartment of Rheumatology, Université Catholique de Lille Hôpital Saint Philibert, Lomme, Nord-Pas-de-Calais-Picardie, FranceRheumatology, Protestant Infirmary of Lyon, Caluire-et-Cuire, Auvergne-Rhône-Alpes, FranceDepartment of Rheumatology, Université Catholique de Lille Hôpital Saint Philibert, Lomme, Nord-Pas-de-Calais-Picardie, FranceDepartment of Rheumatology, Université Catholique de Lille Hôpital Saint Philibert, Lomme, Nord-Pas-de-Calais-Picardie, FranceMethodology Unit, Groupement des Hôpitaux de l’Institut Catholique de Lille, Lomme, FranceIntroduction Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials. In case of TNFi inadequate response, using other mechanisms of action provides a better response than using an alternate TNFi. Which non-TNFi bDMARD administered subcutaneously to allow for ambulatory management to choose in case of first line TNFi inadequate response has not been tested in a randomised clinical trial, while observational data support a potential superiority of tocilizumab over abatacept.Methods and analysis The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI<10, no use of rescue treatment after week 12 and no experimental treatment change, at weeks 12, 24 and 52.Ethics and dissemination Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.Trial registration number NCT03227419 and EudraCT2017-000947-41.https://bmjopen.bmj.com/content/15/6/e098298.full |
| spellingShingle | Bruno Fautrel Pascal Richette Christian Roux Grégoire Cormier Martin Soubrier Xavier Mariette Christophe Richez Jacques-Eric Gottenberg Hubert Marotte Jacques Morel Rene-Marc Flipo Jerome Avouac Athan Baillet Gael Mouterde Anne Tournadre Marie-Elise Truchetet Sebastien Ottaviani Tristan Pascart Thierry Lequerre Elisabeth Gervais Luca Semerano André Basch Edouard Pertuiset Jean-Hugues Salmon Eric Houvenagel VÉRONIQUE BREUIL Marie Vandecandelaere Olivier Vittecocq Isabelle Griffoul Charlotte Jauffret Vincent Ducoulombier Laurène Norberciak Jean-Guillaume Letarouilly Slim Lassoued Renaud Desbarbieux Hélène Luraschi Thibault Rabin Gauthier Marchasson Catherine Godart Nicolas Taisne Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial BMJ Open |
| title | Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial |
| title_full | Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial |
| title_fullStr | Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial |
| title_full_unstemmed | Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial |
| title_short | Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial |
| title_sort | abatacept versus tocilizumab for the treatment of rheumatoid arthritis in tnf inhibitor inadequate responders study protocol of the sunstar randomised controlled open label superiority trial |
| url | https://bmjopen.bmj.com/content/15/6/e098298.full |
| work_keys_str_mv | AT abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT brunofautrel abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT pascalrichette abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT christianroux abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT gregoirecormier abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT martinsoubrier abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT xaviermariette abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT christopherichez abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT jacquesericgottenberg abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT hubertmarotte abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT jacquesmorel abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT renemarcflipo abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT jeromeavouac abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT athanbaillet abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT gaelmouterde abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT annetournadre abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT marieelisetruchetet abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT sebastienottaviani abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT tristanpascart abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT thierrylequerre abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT elisabethgervais abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT lucasemerano abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT andrebasch abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT edouardpertuiset abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT jeanhuguessalmon abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT erichouvenagel abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT veroniquebreuil abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT marievandecandelaere abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT oliviervittecocq abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT isabellegriffoul abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT charlottejauffret abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT vincentducoulombier abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT laurenenorberciak abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT jeanguillaumeletarouilly abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT slimlassoued abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT renauddesbarbieux abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT heleneluraschi abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT thibaultrabin abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT gauthiermarchasson abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT catherinegodart abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial AT nicolastaisne abataceptversustocilizumabforthetreatmentofrheumatoidarthritisintnfinhibitorinadequaterespondersstudyprotocolofthesunstarrandomisedcontrolledopenlabelsuperioritytrial |