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)

  • STATUS
    Recruiting
  • End date
    Jun 24, 2024
  • participants needed
    225
  • sponsor
    University Hospital, Bordeaux
Updated on 24 March 2022
steroidal anti-inflammatory drugs
tumor necrosis factor
NSAID
arthritis
rheumatic diseases
rheumatism
anti-tumor necrosis factor therapy

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.

Details
Condition Ankylosing Spondylitis
Treatment Anti-TNF, NSAIDs
Clinical Study IdentifierNCT02469753
SponsorUniversity Hospital, Bordeaux
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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