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)

University Hospital of Bordeaux

Status and phase

Completed

Phase 3

Conditions

Ankylosing Spondylitis

Treatments

Drug: NSAIDs

Drug: anti-TNF

Study type

Interventional

Funder types

Other

Identifiers

NCT02469753

CHUBX2014/36

Details and patient eligibility

About

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.

Enrollment

188 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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