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)

May 18, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Service de rhumatologie - CHU d'Amiens
      • Besançon, France
        • Service de rhumatologie - CHU de Besançon
      • Bordeaux, France
        • Service de Rhumatologie - CHU de Bordeaux
      • Boulogne-Billancourt, France
        • service de rhumatologie - AP-HP - Hôpital Ambroise Paré
      • Brest, France
        • Service de rhumatologie - CHU de Brest
      • Cahors, France
        • service de rhumatologie - CH de Cahors
      • Le Mans, France
        • service de rhumatologie - CH Le Mans
      • Limoges, France
        • service de rhumatologie - CHU de Limoges
      • Montpellier, France
        • service de rhumatologie - CHU de Montpellier
      • Nancy, France
        • service de rhumatologie - CHU de Nancy
      • Nice, France
        • Service de rhumatologie - CHU de Nice
      • Orléans, France
        • service de rhumatologie - CHR d'Orléans
      • Paris, France
        • service de rhumatologie - AP-HP - Hôpital Henri Mondor
      • Paris, France
        • Service de rhumatologie - AP-HP - Hôpital Lariboisière
      • Paris, France
        • service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
      • Pau, France
        • service de rhumatologuie - CH de Pau
      • Rouen, France
        • service de rhumatologie - CHU de Rouen
      • Saint-Etienne, France
        • service de rhumatologie - CHU de Saint-Etienne
      • Strasbourg, France
        • service de rhumatologie - CHU de Strasbourg
      • Toulouse, France
        • service de rhumatologie - CHU de Toulouse
      • Tours, France
        • Service de rhumatologie - CHU de Tours
  • Monaco
      • Monaco, Monaco
        • service de Rhumatologie - CH Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
Drug: NSAIDs
continuous daily
Drug: NSAIDs
on demand
Drug: anti-TNF
Active Comparator: Patients treated with anti-TNF and NSAIDs on demand
Drug: NSAIDs
continuous daily
Drug: NSAIDs
on demand
Drug: anti-TNF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 month after the begin of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Rodolphe THIEBAUT, Prof, University Hospital Bordeaux, France
  • Principal Investigator: Thierry SCHAEVERBEKE, Prof, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2015

Primary Completion (Actual)

July 4, 2024

Study Completion (Actual)

July 4, 2024

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimated)

June 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2014/36
  • 2015-001004-63 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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