Status:
COMPLETED
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03445845
Start Date
December 14 2018
End Date
October 1 2024
Last Update
November 18 2024
Active Locations (35)
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1
CHU d'Angers
Angers, France
2
CHRU Besançon
Besançon, France
3
APHP- Hôpital Avicenne
Bobigny, France
4
CHU Bordeaux
Bordeau, France