This study is a Phase III, multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial investigating the treatment of lower extremity venous thrombosis associated with Behçet's Disease. The study compares the effectiveness and safety of immunosuppressive therapy alone versus immunosuppressive therapy combined with oral anticoagulation (Rivaroxaban).
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must meet the following criteria to be eligible for the study:
Age between 18-50 years old. Diagnosed with Behçet's Disease according to the International Study Group (ISG) criteria.
No prior vascular involvement or no previous immunosuppressive therapy for vascular involvement.
Confirmed venous thrombosis in the lower extremity within the last 14 days before randomization.
Venous thrombosis diagnosis confirmed by:
Non-compressible venous segment in ultrasound, OR A significant (\>4 mm) increase in thrombus diameter in an already abnormal segment, OR New intraluminal filling defect on venography, CT, or MR angiography.
Female participants must:
Not be pregnant or breastfeeding. Use effective contraception if of childbearing potential. Be postmenopausal (no menses for at least 1 year) or have undergone surgical sterilization.
Ability to provide written informed consent and comply with study requirements.
Exclusion Criteria:
* Participants will be excluded if they meet any of the following criteria:
Presence of any aneurysm. Chronic multisystemic disease other than Behçet's Disease. History of intolerance to Rivaroxaban. Use of immunosuppressive drugs (azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, TNF inhibitors, or interferon-gamma) within the last 6 months.
Prolonged corticosteroid use (\>3 months) for Behçet's Disease mucocutaneous symptoms.
Prior anticoagulant therapy:
Low molecular weight heparin, fon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing immunosuppressive therapy alone against immunosuppressive therapy plus oral anticoagulation for venous thrombosis in Behçet's disease — given that standard care for most blood clots involves anticoagulation, can you explain why it's scientifically uncertain whether adding anticoagulation actually helps in Behçet's specifically?
2The trial is in Phase 3 and is measuring whether thrombotic relapse rates differ between the two approaches over 52 weeks — based on what's currently known, what does my personal risk of a thrombotic relapse look like, and which arm of this study would align better with how you'd normally approach my case?
3Since this trial is not yet recruiting, it may be some time before I could even enroll — should I start one of these treatment approaches now, and if so, would that affect my eligibility or the relevance of this trial for me later?
4Oral anticoagulation carries real bleeding risks, and Behçet's disease can also cause complications in blood vessels — if I were in the anticoagulation arm, how would my doctor and the trial team monitor me for bleeding complications given my specific disease involvement?
5Post-thrombotic syndrome is listed as one of the conditions this trial is focused on — can you explain what post-thrombotic syndrome is, how likely I am to develop it, and whether participating in this trial could affect my risk of it compared to standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.