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NCT02469753CompletedPhase 3

Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes

Source: ClinicalTrials.gov · Last updated 19 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
188 (actual)
First submitted
9 Jun 2015
Start date
23 Oct 2015
Primary completion date
4 Jul 2024
Lead sponsor
University Hospital, Bordeaux
NCT number
NCT02469753
EudraCT number
2015-001004-63

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 188
  • From 23 Oct 2015 to the primary completion date, 4 Jul 2024
  • 22 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who present contraindications to treatment with NSAIDs.
  • Patient with daily corticosteroid treatment at a dosage ≥ 10 mg/day

Other illness

  • Patients who present another chronic systemic inflammatory disorder, different from ankylosing spondylitis.
  • 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

Other

  • Pregnant or breastfeeding women
  • Women that refuse to an effective contraception method for all the study duration

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service de rhumatologie - CHU d'Amiens
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AmiensFranceUnknown status
Service de rhumatologie - CHU de Besançon
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BesançonFranceUnknown status
Service de Rhumatologie - CHU de Bordeaux
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BordeauxFranceUnknown status
service de rhumatologie - AP-HP - Hôpital Ambroise Paré
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Boulogne-BillancourtFranceUnknown status
Service de rhumatologie - CHU de Brest
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BrestFranceUnknown status
service de rhumatologie - CH de Cahors
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CahorsFranceUnknown status
service de rhumatologie - CH Le Mans
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Le MansFranceUnknown status
service de rhumatologie - CHU de Limoges
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LimogesFranceUnknown status
service de rhumatologie - CHU de Montpellier
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MontpellierFranceUnknown status
service de rhumatologie - CHU de Nancy
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NancyFranceUnknown status
Service de rhumatologie - CHU de Nice
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NiceFranceUnknown status
service de rhumatologie - CHR d'Orléans
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OrléansFranceUnknown status
service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
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ParisFranceUnknown status
service de rhumatologie - AP-HP - Hôpital Henri Mondor
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ParisFranceUnknown status
Service de rhumatologie - AP-HP - Hôpital Lariboisière
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ParisFranceUnknown status
service de rhumatologuie - CH de Pau
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PauFranceUnknown status
service de rhumatologie - CHU de Rouen
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RouenFranceUnknown status
service de rhumatologie - CHU de Saint-Etienne
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Saint-EtienneFranceUnknown status
service de rhumatologie - CHU de Strasbourg
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StrasbourgFranceUnknown status
service de rhumatologie - CHU de Toulouse
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ToulouseFranceUnknown status
Service de rhumatologie - CHU de Tours
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ToursFranceUnknown status
service de Rhumatologie - CH Princesse Grace
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MonacoMonacoUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.