Ankylosing SpondylitisPhase 3STOPNCT02469753
Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
A Phase 3 study testing NSAIDs and anti-TNF in people with Ankylosing Spondylitis, run by University Hospital, Bordeaux at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- NSAIDs and anti-TNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 23 Oct 2015to 4 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
France21 sites
Service de rhumatologie - CHU d'Amiens
Amiens
Service de rhumatologie - CHU de Besançon
Besançon
Service de Rhumatologie - CHU de Bordeaux
Bordeaux
service de rhumatologie - AP-HP - Hôpital Ambroise Paré
Boulogne-Billancourt
Service de rhumatologie - CHU de Brest
Brest
service de rhumatologie - CH de Cahors
Cahors
service de rhumatologie - CH Le Mans
Le Mans
service de rhumatologie - CHU de Limoges
Limoges
service de rhumatologie - CHU de Montpellier
Montpellier
service de rhumatologie - CHU de Nancy
Nancy
Service de rhumatologie - CHU de Nice
Nice
service de rhumatologie - CHR d'Orléans
Orléans
service de rhumatologie - AP-HP - Hôpital Henri Mondor
Paris
Service de rhumatologie - AP-HP - Hôpital Lariboisière
Paris
service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
Paris
service de rhumatologuie - CH de Pau
Pau
service de rhumatologie - CHU de Rouen
Rouen
service de rhumatologie - CHU de Saint-Etienne
Saint-Etienne
service de rhumatologie - CHU de Strasbourg
Strasbourg
service de rhumatologie - CHU de Toulouse
Toulouse
Service de rhumatologie - CHU de Tours
Tours
About this study
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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- NSAIDs, anti-TNF
- Keywords
- NSAIDs, Anti-TNF, syndesmophytes, mSASSS
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDsDrug
continuous daily
NSAIDsDrug
on demand
anti-TNFDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with anti-TNF and continuous daily NSAIDs | Experimental | Not described Receives: Drug: NSAIDs; Drug: anti-TNF |
| Patients treated with anti-TNF and NSAIDs on demand | Active comparator | Not described Receives: Drug: NSAIDs; Drug: anti-TNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who show a significant radiographic progression between the two randomised groups of patients
Measured: 24 month after the begin of the treatment
Secondary outcomes (1)
Radiologic evolution between-group comparison
This measure is a composite with :
- MRI
- Clinical evolution of patients
- Quantitative analysis of mSASSS score
Measured: At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start23 Oct 2015
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodolphe THIEBAUT, Prof, Study chair, University Hospital Bordeaux, FranceThierry SCHAEVERBEKE, Prof, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469753
- Sponsor's protocol ID
- CHUBX2014/36
- Other IDs
- 2015-001004-63, 2015
- Acronym
- STOP
- Status last verified
- Jul 2024
- First submitted
- 9 Jun 2015
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT02469753
- Acronym / sponsor ID
- STOP / CHUBX2014/36
- Conditions
- Ankylosing Spondylitis
- Keywords
- NSAIDs, Anti-TNF, syndesmophytes, mSASSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with anti-TNF and continuous daily NSAIDs | Experimental | Drug: NSAIDs, Drug: anti-TNF |
| Patients treated with anti-TNF and NSAIDs on demand | Active comparator | Drug: NSAIDs, Drug: anti-TNF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAIDscontinuous daily | Drug | Patients treated with anti-TNF and continuous daily NSAIDs |
| NSAIDson demand | Drug | Patients treated with anti-TNF and NSAIDs on demand |
| anti-TNF | Drug | Patients treated with anti-TNF and NSAIDs on demand, Patients treated with anti-TNF and continuous daily NSAIDs |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolphe THIEBAUT, Prof study chair
University Hospital Bordeaux, France
Thierry SCHAEVERBEKE, Prof principal investigator
University Hospital Bordeaux, France
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NSAIDs and anti-TNF in people with Ankylosing Spondylitis, run by University Hospital, Bordeaux at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.