Rotation or Change of Biotherapy After TNF blocker treatment failure

Phase 1

• Conditions: axial Spondyloarthritis; MedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2017-004700-22-FR
• Lead Sponsor: CHU SAINT-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Active axSPA with BASDAI>4 and 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
•IfNSAIDs treatment : stable dose for at least on month before inclusion
•Ability to complete questionnaires
•Social security affiliation
•Informed written consent given
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified