Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
STOP
1 other identifier
interventional
188
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2024
CompletedJuly 16, 2024
July 1, 2024
8.7 years
June 9, 2015
July 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Radiologic evolution between-group comparison
At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)
Study Arms (2)
Patients treated with anti-TNF and continuous daily NSAIDs
EXPERIMENTALPatients treated with anti-TNF and NSAIDs on demand
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rodolphe THIEBAUT, Prof
University Hospital Bordeaux, France
- PRINCIPAL INVESTIGATOR
Thierry SCHAEVERBEKE, Prof
University Hospital Bordeaux, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 11, 2015
Study Start
October 23, 2015
Primary Completion
July 4, 2024
Study Completion
July 4, 2024
Last Updated
July 16, 2024
Record last verified: 2024-07