ClinicalTrials.gov record NCT06780462

Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 16, 2026

Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, phase 3 trial tests whether adding the anticoagulant rivaroxaban to standard corticosteroid treatment changes outcomes for deep vein thrombosis (DVT) in people with Behçet syndrome. Participants are assigned to either corticosteroids plus rivaroxaban or corticosteroids alone and followed for outcomes measured at 6 and 12 months. The study will compare DVT relapse, major bleeding, and other safety and disease-activity measures.

What it is studying. The study tests whether combining corticosteroids with the anticoagulant rivaroxaban, compared with corticosteroids alone, affects DVT relapse and major bleeding rates and related safety and disease-activity outcomes.

What the researchers hope to learn. Scientifically, the trial aims to determine whether adding rivaroxaban to corticosteroid therapy influences the rate of DVT recurrence and major bleeding at 6 months, to compare safety profiles of the two treatment approaches, and to measure clinical and quality-of-life outcomes up to 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Corticosteroids + Rivaroxaban
  • Corticosteroids alone

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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 progestogen- containing hormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner).
  • Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study

Exclusion criteria

  • 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 prior to the inclusion visit
  • 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 interventional clinical trial or being in the exclusion period at the end of a previous study

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, you will be randomly assigned to one of two treatment groups: corticosteroids alone or corticosteroids plus the anticoagulant rivaroxaban. You will attend follow-up visits with assessments reported at about 3, 6, and 12 months to check for new or recurrent blood clots, bleeding, and other adverse events. Tests and assessments named in the record include vascular imaging (for example venous ultrasound or angio CT/MRI) to assess vein reopening, quality-of-life questionnaires (SF-36), Behçet's disease activity scores and physician assessments, and blood tests for inflammation (acute-phase reactants); steroid dose and cumulative steroid exposure will also be recorded. The study will collect information on adverse events, major bleeding, and thrombotic events during the follow-up period.

How the study is structured. Interventional (treatment) study, phase 3. Participants are randomized into two parallel groups: corticosteroids plus rivaroxaban, or corticosteroids alone. The trial is single-masked and measures primary outcomes at 6 months with additional outcomes and safety monitored up to 12 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Behcet Syndrome. Does it apply to my diagnosis?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Behçet's disease

This trial is also listed on this site under familial Mediterranean fever.

Clinical trials34 trials listed for Behçet's diseaseEvery trial the registry lists for Behçet's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Behçet's disease researchLatest monthly update: September 2026. Includes: Low-dose IL-2 trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 24, 2025
Primary completion
Dec 24, 2027 (estimated)
Study completion
Jun 24, 2028 (estimated)
Target enrollment
134 participants (estimated)
Last updated on registry
Apr 23, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique - Hôpitaux de Paris

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (17)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
CT scan
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Women of childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
immunosuppressant
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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