Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
- Conditions
- Ankylosing Spondylitis
- Interventions
- Drug: NSAIDsDrug: anti-TNF
- Registration Number
- NCT02469753
- Lead Sponsor
- University Hospital, Bordeaux
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients treated with anti-TNF and continuous daily NSAIDs NSAIDs - Patients treated with anti-TNF and continuous daily NSAIDs anti-TNF - Patients treated with anti-TNF and NSAIDs on demand NSAIDs - Patients treated with anti-TNF and NSAIDs on demand anti-TNF -
- Primary Outcome Measures
Name Time Method Proportion of patients who show a significant radiographic progression between the two randomised groups of patients 24 month after the begin of the treatment
- Secondary Outcome Measures
Name Time Method Radiologic evolution between-group comparison At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment) This measure is a composite with :
* MRI
* Clinical evolution of patients
* Quantitative analysis of mSASSS score
Trial Locations
- Locations (22)
Service de rhumatologie - CHU d'Amiens
🇫🇷Amiens, France
Service de rhumatologie - CHU de Besançon
🇫🇷Besancon, France
Service de rhumatologie - CHU de Brest
🇫🇷Brest, France
service de rhumatologie - AP-HP - Hôpital Ambroise Paré
🇫🇷Boulogne-billancourt, France
Service de Rhumatologie - CHU de Bordeaux
🇫🇷Bordeaux, France
service de rhumatologie - CH de Cahors
🇫🇷Cahors, France
service de rhumatologie - CH Le Mans
🇫🇷Le Mans, France
service de rhumatologie - CHU de Limoges
🇫🇷Limoges, France
service de rhumatologie - CHU de Nancy
🇫🇷Nancy, France
service de rhumatologie - CHU de Montpellier
🇫🇷Montpellier, France
Service de rhumatologie - CHU de Nice
🇫🇷Nice, France
service de rhumatologie - CHR d'Orléans
🇫🇷Orleans, France
service de rhumatologie - AP-HP - Hôpital Henri Mondor
🇫🇷Paris, France
Service de rhumatologie - AP-HP - Hôpital Lariboisière
🇫🇷Paris, France
service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
🇫🇷Paris, France
service de rhumatologuie - CH de Pau
🇫🇷PAU, France
service de rhumatologie - CHU de Rouen
🇫🇷Rouen, France
service de rhumatologie - CHU de Strasbourg
🇫🇷Strasbourg, France
service de rhumatologie - CHU de Saint-Etienne
🇫🇷Saint-etienne, France
service de rhumatologie - CHU de Toulouse
🇫🇷Toulouse, France
Service de rhumatologie - CHU de Tours
🇫🇷Tours, France
service de Rhumatologie - CH Princesse Grace
🇲🇨Monaco, Monaco