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Compares treatment options for Behcet Syndrome
Official title Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
ClinicalTrials.gov ID: NCT06780462
What this study is testing
What is Corticosteroids + Rivaroxaban?
Corticosteroids + Rivaroxaban is an investigational medicine, being studied as a potential treatment for behcet syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old
- Diagnosis of BS according to the international criteria
- First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
- Written inform consent
- Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment...
You likely can't join if
- Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)
- Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
- Isolated superficial thrombosis without concomitant deep venous thrombosis.
- Pregnancy or lactation
- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the...
- Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion
See the full eligibility criteria
- Age ≥ 18 years old
- Diagnosis of BS according to the international criteria
- First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
- Written inform consent
- Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie, abstinence, combined estrogen- and...
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
- Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)
- Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
- Isolated superficial thrombosis without concomitant deep venous thrombosis.
- Pregnancy or lactation
- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 4000 mg methylprednisolone 4 weeks...
- Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion
- Severe chronic renal (creatinine clearance \<30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
- Platelet count \< 50 x 103/mm3
- Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit.
- Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
- Participation to another treatment clinical trial or being in the exclusion period at the end of a previous study
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Boulogne-Billancourt, France
- Caen, France
- Créteil, France
- Grenoble, France
- Le Kremlin-Bicêtre, France
- Lyon, France
- Melun, France
- Nancy, France
- Nantes, France
- Paris, France
- Pessac, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Boulogne-Billancourt, France; Caen, France; Créteil, France; Grenoble, France; Le Kremlin-Bicêtre, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.