Informations générales (source: ClinicalTrials.gov)
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis (ROC-SPA)
Interventional
Phase 4
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
décembre 2018
novembre 2025
29 juin 2024
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by
inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around
0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined
in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA
patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs).
Until few months, the only choice was to use a second TNF blocker.Since 2003,
pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid
arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc
fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies.
Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All
demonstrated efficacy versus placebo in a randomized double blinded study
In case of failure to the first TNF blockers, rheumatologists will follow the
"Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid
arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low
levels of evidence and recommendation. So rheumatologist will provide the best treatment
in case of failure to the first TNF blockers, which is a daily clinical situation. Since
few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a
second TNF blocker.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Bicêtre | Stephan Pavy, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bichat | Philippe Dieudé, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Corinne Miceli, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Pascal Claudepierre, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Jérémie Sellam, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Lyon SUD - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHRU Brest - Brest - France | Valérie Devauchelle, MD | Contact (sur clinicalTrials) | |||
| CHRU Montpellier - Montpellier - France | Cédric Lukas, MD | Contact (sur clinicalTrials) | |||
| CHRU Tours - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - Bordeau - France | Thierry Schaeverbeke, MD | Contact (sur clinicalTrials) | |||
| CHU Clermont-Ferrand - Clermont-Ferrand - France | Anne Tournadre, MD | Contact (sur clinicalTrials) | |||
| CHU de Grenoble Alpes - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - Nantes - France | Benoît Le Goff, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - Nice - France | Christian Roux, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Poitiers - France | Elisabeth Solau, MD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Rouen - France | Thierry Lequerré, MD | Contact (sur clinicalTrials) | |||
| CHU Nancy - Nancy - France | Damien Loeuille, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Arnaud Constantin, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Hôpital Ambroise Paré - Paris - France | Maxime Breban, MD | 23/02/2021 10:15:00 | Contact (sur clinicalTrials) | ||
| APHP - Hôpital Lariboisière - Paris - France | Pascal Richette, MD | Contact (sur clinicalTrials) | |||
| APHP - Hôpital Pitié-Salpétrière - Paris - France | Laure Gossec | Contact (sur clinicalTrials) | |||
| CH Le Mans - Le Mans - France | Emmanuelle Dernis, MD | Contact (sur clinicalTrials) | |||
| CHR d'Orléans - Orléans - France | Eric Lespessailles, MD | Contact (sur clinicalTrials) | |||
| CHRU Besançon - Besançon - France | Daniel Wendling, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | René-Marc Flipo, MD | Contact (sur clinicalTrials) | |||
| CHU d'Angers - Angers - France | Erick LEGRAND, PhD | Contact (sur clinicalTrials) | |||
| CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Saint-Etienne - 42055 - Saint-Étienne - France | Hubert Marotte, MD | Contact (sur clinicalTrials) | |||
| CHU STRASBOURG - Hautepierre - 67200 - Strasbourg - France | Renaud FELTEN, MD | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Philibert - Lomme - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Active axSPA with BASDAI>4 or ASDAS>3.5, who need change in TNF blocker treatment
- Aged over 18 years
- Inadequate response after at least 3 months to the 1st TNF blocker
- If non biologic DMARD treatment : stable dose for at least on month before inclusion
- If oral corticosteroids treatment : stable dose for at least on month before
inclusion
- If NSAIDs treatment : stable dose for at least on month before inclusion
- Ability to complete questionnaires
- Social security affiliation
- Informed written consent given
- Active axSPA with BASDAI>4 or ASDAS>3.5, who need change in TNF blocker treatment
- Aged over 18 years
- Inadequate response after at least 3 months to the 1st TNF blocker
- If non biologic DMARD treatment : stable dose for at least on month before inclusion
- If oral corticosteroids treatment : stable dose for at least on month before
inclusion
- If NSAIDs treatment : stable dose for at least on month before inclusion
- Ability to complete questionnaires
- Social security affiliation
- Informed written consent given
- Any contra-indication to TNF blocker and/or secukinumab
- Inflammatory bowel diseases
- Existing pregnancy, lactation, or intended pregnancy within the next 15 months
Active tuberculosis or other severe infections such as sepsis or opportunistic
infections
- Active infections, including chronic or localised infections.
- Moderate to severe heart failure (NYHA classes III/IV)
- Impossibility to give informed consent
- Impossibility to be followed for 12 months