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In patients with Behçet's syndrome (BS), deep venous thrombosis (DVT) is thought to result from inflammation of the vessel wall rather than hyper coagulability.
Post Thrombotic Syndrome (PTS) is frequent especially with recurrent episodes of deep vein thrombosis and may result in leg ulcers that are very difficult to treat. Vascular involvement is a major cause of morbidity and mortality among BS patients. However, one of the most controversial issues regarding the management of BS is whether DVT should be treated with anticoagulants. Moreover, use of anticoagulants exposes patients to serious bleeding, especially in those who presents simultaneous arterial aneurysms. However, many physicians are still using anticoagulants. This is the first prospective, randomized study assessing benefits of corticosteroids associated with anticoagulant compared to that of corticosteroids alone in DVT in BS patients. It will validate or not the use of anticoagulants in those situations. It will allow a direct comparison of the safety profile of those two schemes of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroids and Rivaroxaban | Experimental |
| |
| Corticosteroids alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroids + Rivaroxaban | Drug | Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market) and Rivaroxaban |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of success | Defined as absence of deep venous thrombosis relapse and of major bleeding event, without introduction of additional immunosuppressive medication for BS activity other than thrombotic events at 6 months. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse | At 12 months | |
| Cumulative incidence of major venous thrombosis | pulmonary embolism, vena cava , Budd Chiari syndrome , intra-cardiac relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Saadoun, MD PhD | Contact | 0142178042 | +33 | david.saadoun@psl.aphp.fr |
| Jérôme Lambert, MD PhD | Contact | 0142499742 | +33 | jerome.lambert@u-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU BORDEAUX Hôpital Saint-André | Recruiting | Bordeaux | France |
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Randomised, controlled, multicentre, superiority study
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| Corticosteroids alone | Drug | Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market) |
|
| At 12 months |
| Cumulative incidence of venous repermeabilization | assessed by vascular imaging | At 6 months |
| Proportion of patients with a dose ≤ 5 mg/day of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 6 months |
| Proportion of patients with a dose ≤ 5 mg/day of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 12 months |
| Dose of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 3 months |
| Dose of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 6 months |
| Dose of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 12 months |
| Cumulative dose of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 3 months |
| Cumulative dose of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 6 months |
| Cumulative dose of prednisone | (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) | At 12 months |
| Cumulative incidence of major bleeding event | At 12 months |
| Cumulative incidence of bleeding event | At 12 months |
| Number of adverse events | At 3 months |
| Number of adverse events | At 6 months |
| Number of adverse events | At 12 months |
| Change in SF-36 quality-of-life | The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability. | At 3 months |
| Change in SF-36 quality-of-life | The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability. | At 6 months |
| Change in SF-36 quality-of-life | The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability. | At 12 months |
| Change in Behçet's Disease Current Activity Form | It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease. | At 3 months |
| Change in Behçet's Disease Current Activity Form | It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease. | At 6 months |
| Change in Behçet's Disease Current Activity Form | It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease. | At 12 months |
| Change in Behçet's Syndrome Assessment Score | It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease. | At 3 months |
| Change in Behçet's Syndrome Assessment Score | It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease. | At 6 months |
| Change in Behçet's Syndrome Assessment Score | It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease. | At 12 months |
| Change in Physician Global Assessment | Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease. | At 3 months |
| Change in Physician Global Assessment | Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease. | At 6 months |
| Change in Physician Global Assessment | Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease. | At 12 months |
| Overall survival | At 12 months |
| Event free survival | At 12 months |
| Proportion of post thrombotic syndrome | According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms | At 12 months |
| Changes in Villalta's post-thrombotic syndrome scale | According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms | At 6 months |
| Changes in Villalta's post-thrombotic syndrome scale | According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms | At 12 months |
| Proportion of remission | According to other organs involved | At 3 months |
| Proportion of remission | According to other organs involved | At 6 months |
| Proportion of remission | According to other organs involved | At 12 months |
| Changes in acute-phase reactants | At 1 month |
| Changes in acute-phase reactants | At 3 months |
| Changes in acute-phase reactants | At 6 months |
| Changes in acute-phase reactants | At 12 months |
| Ambroise Paré hospital AP-HP | Recruiting | Boulogne-Billancourt | France |
|
| CHU Caen | Recruiting | Caen | France |
|
| Hopital Henri Mondor AP-HP | Recruiting | Créteil | France |
|
| Chu de Grenoble | Recruiting | Grenoble | France |
|
| Hôpital Bicêtre | Recruiting | Le Kremlin-Bicêtre | France |
|
| Hcl, Hopital de La Croix Rousse | Recruiting | Lyon | France |
|
| Centre Hospitalier de Melun | Recruiting | Melun | France |
|
| CHRU DE Nancy Hôpitaux de Brabois | Recruiting | Nancy | France |
|
| Hôpital Hôtel-Dieu | Recruiting | Nantes | France |
|
| Hopital Européen Georges Pompidou AP-HP | Recruiting | Paris | France |
|
| Hôpital Lariboisière AP-HP | Recruiting | Paris | France |
|
| Hôpital Saint Antoine AP-HP | Recruiting | Paris | France |
|
| Hôpital Tenon AP-HP | Recruiting | Paris | France |
|
| La Pitié Salpetriere hospital | Recruiting | Paris | France |
|
| CHU Bordeaux- GHU SUD hôpital Haut-Lévêque | Recruiting | Pessac | France |
|
| CHU DE ROUEN, Hôpital CHARLES NICOLLE | Recruiting | Rouen | France |
|
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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