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.
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's enrollment of 188 is above the median of 88 across 302 interventional studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: NSAIDs · Drug: anti-TNF
Drug: NSAIDs · Drug: anti-TNF
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)
Ran from Oct 2015 to primary completion in Jul 2024, 104 months.
Of 40 phase 3 interventional studies under Spondylitis, Ankylosing, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 32. This study's 104 months is above that.
How these figures are worked out, and which studies are left out of them.
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 →