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 Overview
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Brief Summary
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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.

Official Title
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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
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: NSAIDs
* Drug: NSAIDs
* Drug: anti-TNF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with anti-TNF and continuous daily NSAIDs<br> | Drug: NSAIDs<br>* continuous daily<br>Drug: anti-TNF<br> <br> |
| Active Comparator: Patients treated with anti-TNF and NSAIDs on demand<br> | Drug: NSAIDs<br>* on demand<br>Drug: anti-TNF<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAIDs, Anti-TNF, syndesmophytes, mSASSS