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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT02469753 |
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Date of registration:
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09/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes |
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Date of first enrolment:
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October 23, 2015 |
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Target sample size:
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188 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02469753 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Monaco
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Contacts
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Name:
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Thierry SCHAEVERBEKE, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux, France |
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Name:
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Rodolphe THIEBAUT, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux, France |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: anti-TNF
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Drug: NSAIDs
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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)]
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Secondary ID(s)
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CHUBX2014/36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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