Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
NCT ID: NCT02469753
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
188 participants
INTERVENTIONAL
2015-10-23
2024-07-04
Brief Summary
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Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients treated with anti-TNF and continuous daily NSAIDs
NSAIDs
continuous daily
anti-TNF
Patients treated with anti-TNF and NSAIDs on demand
NSAIDs
on demand
anti-TNF
Interventions
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NSAIDs
continuous daily
NSAIDs
on demand
anti-TNF
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Rodolphe THIEBAUT, Prof
Role: STUDY_CHAIR
University Hospital Bordeaux, France
Thierry SCHAEVERBEKE, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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Service de rhumatologie - CHU d'Amiens
Amiens, , France
Service de rhumatologie - CHU de Besançon
Besançon, , France
Service de Rhumatologie - CHU de Bordeaux
Bordeaux, , France
service de rhumatologie - AP-HP - Hôpital Ambroise Paré
Boulogne-Billancourt, , France
Service de rhumatologie - CHU de Brest
Brest, , 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 Montpellier
Montpellier, , France
service de rhumatologie - CHU de Nancy
Nancy, , France
Service de rhumatologie - CHU de Nice
Nice, , France
service de rhumatologie - CHR d'Orléans
Orléans, , 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 Saint-Etienne
Saint-Etienne, , France
service de rhumatologie - CHU de Strasbourg
Strasbourg, , 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
Countries
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Other Identifiers
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CHUBX2014/36
Identifier Type: -
Identifier Source: org_study_id
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