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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001004-63 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with anti-TNF and continuous daily NSAIDs | Experimental |
| |
| Patients treated with anti-TNF and NSAIDs on demand | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSAIDs | Drug | continuous daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who show a significant radiographic progression between the two randomised groups of patients | 24 month after the begin of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic evolution between-group comparison | This measure is a composite with :
| At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodolphe THIEBAUT, Prof | University Hospital Bordeaux, France | Study Chair |
| Thierry SCHAEVERBEKE, Prof | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de rhumatologie - CHU d'Amiens | Amiens | France | ||||
| Service de rhumatologie - CHU de Besançon |
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| NSAIDs |
| Drug |
on demand |
|
| anti-TNF | Drug |
|
| Besançon |
| France |
| Service de Rhumatologie - CHU de Bordeaux | Bordeaux | France |
| service de rhumatologie - AP-HP - Hôpital Ambroise Paré | Boulogne-Billancourt | France |
| Service de rhumatologie - CHU de Brest | Brest | France |
| service de rhumatologie - CH de Cahors | Cahors | France |
| service de rhumatologie - CH Le Mans | Le Mans | France |
| service de rhumatologie - CHU de Limoges | Limoges | France |
| service de rhumatologie - CHU de Montpellier | Montpellier | France |
| service de rhumatologie - CHU de Nancy | Nancy | France |
| Service de rhumatologie - CHU de Nice | Nice | France |
| service de rhumatologie - CHR d'Orléans | Orléans | 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 | Paris | France |
| service de rhumatologuie - CH de Pau | Pau | France |
| service de rhumatologie - CHU de Rouen | Rouen | France |
| service de rhumatologie - CHU de Saint-Etienne | Saint-Etienne | France |
| service de rhumatologie - CHU de Strasbourg | Strasbourg | France |
| service de rhumatologie - CHU de Toulouse | Toulouse | France |
| Service de rhumatologie - CHU de Tours | Tours | France |
| service de Rhumatologie - CH Princesse Grace | Monaco | Monaco |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
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