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 (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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de rhumatologie - CHU d'Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NSAIDs

Drug

continuous daily

Anti-TNF

Drug

Primary outcomes

Proportion of patients who show a significant radiographic progression between the two randomised groups of patients

Time frame: 24 month after the begin of the treatment

Secondary outcomes

Radiologic evolution between-group comparison

Time frame: At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)
This measure is a composite with :
- MRI
- Clinical evolution of patients
- Quantitative analysis of mSASSS score

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: STOP

Important dates

Study start: 2015
Primary completion: 2024
Study completion: 2024
First posted: Jun 11, 2015
Registry last updated: May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed