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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| ClinicalTrials.gov Identifier: NCT02469753 |
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Recruitment Status :
Recruiting
First Posted : June 11, 2015
Last Update Posted : January 27, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankylosing Spondylitis | Drug: NSAIDs Drug: anti-TNF | Phase 3 |
| Study Type : | Interventional |
| Estimated Enrollment : | 225 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 23, 2015 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | June 2024 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Patients treated with anti-TNF and continuous daily NSAIDs |
Drug: NSAIDs
continuous daily Drug: anti-TNF |
| Active Comparator: Patients treated with anti-TNF and NSAIDs on demand |
Drug: NSAIDs
on demand Drug: anti-TNF |
- 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 ]
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469753
| Contact: Thierry SCHAEVERBEKE, Prof | (0)556795556 ext +33 | thierry.schaeverbeke@chu-bordeaux.fr | |
| Contact: Thomas BARNETCHE, PhD | (0)557820493 ext +33 | thomas.barnetche@chu-bordeaux.fr |
Show 22 study locations
| Study Chair: | Rodolphe THIEBAUT, Prof | University Hospital Bordeaux, France | |
| Principal Investigator: | Thierry SCHAEVERBEKE, Prof | University Hospital Bordeaux, France |
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT02469753 |
| Other Study ID Numbers: |
CHUBX2014/36 |
| First Posted: | June 11, 2015 Key Record Dates |
| Last Update Posted: | January 27, 2021 |
| Last Verified: | January 2021 |
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NSAIDs Anti-TNF syndesmophytes mSASSS |
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Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis |
Joint Diseases Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |