NCT02469753CompletedPhase 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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (actual)
- First submitted
- 9 Jun 2015
- Start date
- 23 Oct 2015
- Primary completion date
- 4 Jul 2024
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT02469753
- EudraCT number
- 2015-001004-63
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 188
- From 23 Oct 2015 to the primary completion date, 4 Jul 2024
- 22 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who present contraindications to treatment with NSAIDs.
- Patient with daily corticosteroid treatment at a dosage ≥ 10 mg/day
Other illness
- Patients who present another chronic systemic inflammatory disorder, different from ankylosing spondylitis.
- 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
Other
- Pregnant or breastfeeding women
- Women that refuse to an effective contraception method for all the study duration
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de rhumatologie - CHU d'Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Service de rhumatologie - CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Service de Rhumatologie - CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| service de rhumatologie - AP-HP - Hôpital Ambroise Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Unknown status |
| Service de rhumatologie - CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| service de rhumatologie - CH de Cahors Coordinator of this site? Confirm its status | Cahors | France | Unknown status |
| service de rhumatologie - CH Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| service de rhumatologie - CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| service de rhumatologie - CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| service de rhumatologie - CHU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Service de rhumatologie - CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| service de rhumatologie - CHR d'Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| service de rhumatologie - AP-HP - Hôpital Henri Mondor Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Service de rhumatologie - AP-HP - Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| service de rhumatologuie - CH de Pau Coordinator of this site? Confirm its status | Pau | France | Unknown status |
| service de rhumatologie - CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| service de rhumatologie - CHU de Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| service de rhumatologie - CHU de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| service de rhumatologie - CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Service de rhumatologie - CHU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| service de Rhumatologie - CH Princesse Grace Coordinator of this site? Confirm its status | Monaco | Monaco | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.