Clinical trial NCT02469753: Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
Official title: Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: NSAIDs
Anti-TNF
syndesmophytes
mSASSS
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Radiologic evolution between-group comparison
timeFrame: At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Service de rhumatologie - CHU d'Amiens
city: Besancon
country: France
facility: Service de rhumatologie - CHU de Besançon
city: Bordeaux
country: France
facility: Service de Rhumatologie - CHU de Bordeaux
city: Boulogne-billancourt
country: France
facility: service de rhumatologie - AP-HP - Hôpital Ambroise Paré
city: Brest
country: France
facility: Service de rhumatologie - CHU de Brest
city: Cahors
country: France
facility: service de rhumatologie - CH de Cahors
city: Le Mans
country: France
facility: service de rhumatologie - CH Le Mans
city: Limoges
country: France
facility: service de rhumatologie - CHU de Limoges
city: Montpellier
country: France
facility: service de rhumatologie - CHU de Montpellier
city: Nancy
country: France
facility: service de rhumatologie - CHU de Nancy
city: Nice
country: France
facility: Service de rhumatologie - CHU de Nice
city: Orleans
country: France
facility: service de rhumatologie - CHR d'Orléans
city: Paris
country: France
facility: service de rhumatologie - AP-HP - Hôpital Henri Mondor
city: Paris
country: France
facility: Service de rhumatologie - AP-HP - Hôpital Lariboisière
city: Paris
country: France
facility: service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
city: PAU
country: France
facility: service de rhumatologuie - CH de Pau
city: Rouen
country: France
facility: service de rhumatologie - CHU de Rouen
city: Saint-etienne
country: France
facility: service de rhumatologie - CHU de Saint-Etienne
city: Strasbourg
country: France
facility: service de rhumatologie - CHU de Strasbourg
city: Toulouse
country: France
facility: service de rhumatologie - CHU de Toulouse
city: Tours
country: France
facility: Service de rhumatologie - CHU de Tours
city: Monaco
country: Monaco
facility: service de Rhumatologie - CH Princesse Grace
Study officials:
affiliation: University Hospital Bordeaux, France
name: Rodolphe THIEBAUT, Prof
role: STUDY_CHAIR
affiliation: University Hospital Bordeaux, France
name: Thierry SCHAEVERBEKE, Prof
role: PRINCIPAL_INVESTIGATOR
References: