Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis (ROC-SPA)
Axial Spondyloarthritis
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring TNF blocker, change of biotherapy
Eligibility Criteria
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
Exclusion Criteria:
- 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
Sites / Locations
- CHU d'AngersRecruiting
- CHRU BesançonRecruiting
- APHP- Hôpital Avicenne
- CHU BordeauxRecruiting
- CHRU BrestRecruiting
- CHU Clermont-FerrandRecruiting
- CHU de Grenoble AlpesRecruiting
- CHD VendéeRecruiting
- CH Le MansRecruiting
- CHRU Lille
- Hôpital Saint-PhilibertRecruiting
- CH Lyon SUDRecruiting
- Hôpital Edouard HerriotRecruiting
- CHRU MontpellierRecruiting
- CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-ArticulairesRecruiting
- CHU NancyRecruiting
- CHU de NantesRecruiting
- CHU de NiceRecruiting
- CHR d'OrléansRecruiting
- APHP - Hôpital Ambroise ParéRecruiting
- APHP - Hôpital Bichat
- APHP - Hôpital CochinRecruiting
- APHP - Hôpital Henri MondorRecruiting
- APHP - Hôpital Lariboisière
- APHP - Hôpital Pitié-SalpétrièreRecruiting
- APHP - Hôpital Saint-AntoineRecruiting
- APHP - Kremlin-BicêtreRecruiting
- CHU de PoitiersRecruiting
- CHU ReimsRecruiting
- CHU de RouenRecruiting
- CHU Saint-EtienneRecruiting
- CHU STRASBOURG - HautepierreRecruiting
- CHU ToulouseRecruiting
- CHRU ToursRecruiting
- CH Princesse de GraceRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
targeting IL-23/17 axis
TNF blocker
The experimental group (targeting IL-23/17 axis) receiving secukinumab in compliance with the marketing authorization regimen: 150 mg per week for 5 weeks, and then every month by subcutaneous injection. Blood specimen at each visits
• The control group receiving a second TNF blocker in compliance with the marketing authorization regimen: The TNF blocker (originator or biosimilar) will be different to the TNF used before the inclusion and will be chose by the investigator: infliximab: 5mg/kg per IV infusion at weeks 0, 2, 6, and then every 6 weeks, etanercept: 50mg per week in subcutaneous injection, adalimumab: 40mg every other week in subcutaneous injection, certolizumab: 400mg every other week 3 times, and then 200mg every other week or 400mg per month in subcutaneous injections, golimumab: 50mg every month in subcutaneous injection, in case of overweight (>100kg) an inadequate response, 100mg every month is allow. Blood specimen at each visits