Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis P… (NCT02469753) | Clinical Trial Compass
CompletedPhase 3
Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
France, Monaco188 participantsStarted 2015-10-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged over 18 years old
* Patients who fulfil 1984 modified New York criteria for ankylosing spondylitis:
* SA patients with indications for anti-TNF treatment initiation according to the French society of Rheumatology guidelines.
* Being affiliated to a health insurance system
* Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)
Exclusion Criteria:
* Patients who present another chronic systemic inflammatory disorder, different from ankylosing spondylitis.
* Patients who present contraindications to treatment with NSAIDs.
* Patient with daily corticosteroid treatment at a dosage ≥ 10 mg/day
* Pregnant or breastfeeding women
* Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing to undergo MRI
* Women that refuse to an effective contraception method for all the study duration
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether taking NSAIDs continuously alongside anti-TNF therapy slows down bone damage on X-rays in ankylosing spondylitis — since it's now completed, can you tell me what the results showed and whether continuous NSAID use actually made a meaningful difference to radiographic progression?
2Because this was a Phase 3 trial comparing continuous versus on-demand NSAID use in people already on anti-TNF therapy, does that mean the safety profile of this combination is reasonably well understood, and what are the main risks I should be aware of with long-term NSAID use on top of an anti-TNF drug?
3The trial was specifically measuring X-ray changes over time — how would my doctor monitor me for similar radiographic progression if I were on a comparable treatment plan, and how often would imaging typically be done?
4Since this study focused on people already receiving anti-TNF therapy, would I need to already be on or eligible for an anti-TNF treatment for these findings to be relevant to my situation, and is that something worth discussing as part of my treatment plan?
5Given that this trial is now completed, are the results published somewhere my doctor could review, and would the findings change their recommendation about whether I should take NSAIDs continuously or only when I have flares?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who show a significant radiographic progression between the two randomised groups of patients
Timeframe: 24 month after the begin of the treatment