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Study on Steroid and Rivaroxaban Treatment for Deep Vein Thrombosis in Behçet's Syndrome Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of deep venous thrombosis related to Behçet's syndrome. Deep venous thrombosis is a condition where blood clots form in the deep veins, often in the legs, which can lead to serious complications. Behçet's syndrome is a rare disorder that causes blood vessel inflammation throughout the body. The study will compare the effectiveness of using a combination of steroid therapy and anticoagulants versus steroid therapy alone. Steroid therapy involves using medications like prednisone to reduce inflammation, while anticoagulants, such as rivaroxaban, help prevent blood clots.

The purpose of the study is to assess how well the combination of treatments works in reducing the recurrence of deep venous thrombosis without causing major bleeding. Participants will be randomly assigned to receive either the combination of steroid therapy and anticoagulants or steroid therapy alone. The study will last for several months, during which participants will take the medications orally and attend regular check-ups to monitor their health and the effectiveness of the treatment.

Throughout the study, researchers will observe the rate of deep venous thrombosis relapse, any major bleeding events, and the overall health of the participants. They will also look at the quality of life and any changes in the activity of Behçet's syndrome. The study aims to provide valuable information on the best treatment approach for managing deep venous thrombosis in patients with Behçet's syndrome.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), diagnosis of Behçet's syndrome, and a confirmed case of deep venous thrombosis through imaging techniques like ultrasound or CT scan.

    Written consent is required, and participants must be affiliated with a social security system.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving steroid therapy plus anticoagulants, and the other receiving steroid therapy alone.

    The main objective is to assess the effectiveness and safety of combining prednisone with an anticoagulant compared to prednisone alone.

  3. Step 3

    Medication administration

    Participants in the combination group receive rivaroxaban orally, alongside prednisone. The dosage and frequency are determined by the study protocol.

    Participants in the steroid-only group receive prednisone or an equivalent dose if prednisone is unavailable.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor the absence of deep venous thrombosis relapse and major bleeding events over a period of 6 months.

    Additional evaluations include imaging to assess venous repermeabilization and monitoring of corticosteroid sparing, with specific dose targets at 3, 6, and 12 months.

  5. Step 5

    Follow-up

    Participants are followed for 12 months to track the cumulative incidence of thrombosis relapse, major bleeding events, and other health outcomes.

    Quality of life and disease activity scores are measured at 3, 6, and 12 months to assess changes from the baseline.

  6. Step 6

    Completion

    The study aims to conclude by May 2028, with the primary endpoint being the rate of success in preventing thrombosis relapse and major bleeding without additional medication.

    Secondary endpoints include various health measures and overall survival within 12 months from randomization.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Must have a **diagnosis of Behçet's syndrome (BS)** according to international criteria. Behçet's syndrome is a rare condition that causes blood vessel inflammation.
  • Must have a **first or recurrent deep venous thrombosis** diagnosed through imaging tests. Deep venous thrombosis is a condition where a blood clot forms in a deep vein, usually in the legs. Imaging tests like venous ultrasonography, Angio CT scan, or angio MRI are used to confirm this.
  • Must provide **written informed consent**, which means agreeing to participate in the study after understanding all the details.
  • Must be **affiliated with a social security system**. This includes patients who have universal medical coverage, known as CMU.

Who cannot join the trial?

3 criteria

  • Patients who do not have a diagnosis of **newly diagnosed or relapsing deep venous thrombosis** related to **Behçet’s syndrome** cannot participate. **Deep venous thrombosis** is a condition where blood clots form in deep veins, usually in the legs. **Behçet’s syndrome** is a rare disorder that causes blood vessel inflammation throughout the body.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.
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Investigated drugs

  • Prednisone

    is a type of steroid medication used in this study to help reduce inflammation and suppress the immune system. It is being tested to see if it can help reduce the rate of relapse of deep venous thrombosis in patients with Behçet's syndrome.

  • Anticoagulants

    are medications that help prevent blood clots from forming. In this study, they are used in combination with prednisone to see if they can more effectively reduce the rate of relapse of deep venous thrombosis in patients with Behçet's syndrome compared to using prednisone alone.

What is already known about the treatment

  • Prednisone

    Prednisone is administered orally in the form of tablets. It is currently well-established in medical practice and literature as a treatment for various inflammatory and autoimmune conditions. The main therapeutic indication in this trial is to manage deep venous thrombosis associated with Behçet’s syndrome. Prednisone works by suppressing the immune system and reducing inflammation through its action on glucocorticoid receptors, which influences the expression of anti-inflammatory proteins. It is classified as a corticosteroid.

  • Anticoagulants

    Anticoagulants are typically administered orally or via injection, depending on the specific medication. They are widely recognized in medical literature for their role in preventing and treating blood clots. In this trial, they are used alongside prednisone to treat deep venous thrombosis in Behçet’s syndrome. Anticoagulants function by inhibiting various factors in the blood clotting process, thereby reducing the formation of clots. They belong to the pharmacological class of blood thinners.

Investigated diseases

Behçet's Syndrome – Behçet's Syndrome is a rare, chronic condition that causes inflammation in blood vessels throughout the body. It is characterized by recurrent mouth and genital sores, eye inflammation, and skin lesions. The disease can also affect other parts of the body, including the joints, blood vessels, and nervous system. Symptoms can vary greatly from person to person and may come and go over time. The exact cause of Behçet's Syndrome is unknown, but it is believed to involve an abnormal immune response. The disease can lead to complications such as deep venous thrombosis, which is a blood clot in a deep vein, often in the legs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510262-27-00Protocol codeAPHP220673Estimated enrolment134 patientsSponsorAssistance Publique Hopitaux De Paris

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