A Phase 3 interventional study of NSAIDs and NSAIDs in Ankylosing Spondylitis, sponsored by University Hospital, Bordeaux. Completed at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural progression of AS, some data even suggesting that it may accelerate the formation of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit ossification phenomena independently of their anti-inflammatory properties, owing to a specific action on bone formation via prostaglandin inhibition.
Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.
Exclusion Criteria:
Drug: NSAIDs · Drug: anti-TNF
Drug: NSAIDs · Drug: anti-TNF
continuous daily
on demand
Proportion of patients who show a significant radiographic progression between the two randomised groups of patients
Time frame: 24 month after the begin of the treatment
Radiologic evolution between-group comparison
This measure is a composite with : * MRI * Clinical evolution of patients * Quantitative analysis of mSASSS score
Time frame: At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux