Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes

Ankylosing Spondylitis Clinical Trial

— STOP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02469753
• Other study ID #: CHUBX2014/36
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 23, 2015
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• NSAIDs
continuous daily
• NSAIDs
on demand
• anti-TNF

Locations

Country	Name	City	State
France	Service de rhumatologie - CHU d'Amiens	Amiens
France	Service de rhumatologie - CHU de Besançon	Besancon
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	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 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
Monaco	service de Rhumatologie - CH Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiologic evolution between-group comparison	This measure is a composite with : MRI; Clinical evolution of patients; Quantitative analysis of mSASSS score	At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)