ClinicalTrials.gov record NCT06925698

Immunosuppressive Therapy Alone Versus Plus Oral Anticoagulation in the Treatment of VT Associated With Behcet's Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Immunosuppressive Therapy Alone Versus Immunosuppressive Therapy Plus Oral Anticoagulation in the Treatment of Lower Extremity Venous Thrombosis Associated With Behcet's Disease

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
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 to 50 years old
SexAll
LocationTurkey
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 Phase III randomized, placebo-controlled trial compares standard immunosuppressive treatment alone with the same treatment plus oral rivaroxaban in people with Behçet's disease who have a new lower-extremity venous thrombosis. Participants are assigned to one of two groups and treated for 12 months, with planned follow-up visits through week 52. The study is masked and uses a placebo control.

What it is studying. The study tests whether adding oral rivaroxaban to standard immunosuppressive therapy changes the rate of thrombotic relapse and the development of post-thrombotic syndrome in Behçet-associated lower-extremity DVT.

What the researchers hope to learn. To measure the rate of thrombotic relapse at 52 weeks and compare between study arms. Secondary scientific goals include assessing development of post-thrombotic syndrome, degree of venous recanalization, quality of life measures, and the incidence of major and clinically relevant non-major bleeding.

What this study is about

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

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).

Interventions being studied

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

Drug
  • Placebo plus immunosuppression
  • Rivaroxaban plus immunosupression

Eligibility

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

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, fondaparinux, or unfractionated heparin for >48 hours before randomization.
  • More than one dose of vitamin K antagonists before randomization. Thrombectomy, vena cava filter placement, or fibrinolytic therapy for the current thrombotic episode.
  • Planned administration of a live vaccine within 30 days after randomization. Clinically significant acute or uncontrolled chronic diseases (e.g., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) that may interfere with study results.
  • Planned surgical procedure or significant medical condition deemed unsuitable for the study by the investigator.
  • History of malignancy within the last 5 years (except adequately treated basal or squamous cell carcinoma or carcinoma in situ of the cervix).
  • Renal impairment (Creatinine clearance <30 ml/min). Severe liver disease (e.g., acute hepatitis, active chronic hepatitis, cirrhosis, or ALT >3 times the upper limit).
  • Active bleeding or high bleeding risk contraindicating anticoagulant therapy. Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg). Severe anemia (Hemoglobin <10 mg/dL). Women who are pregnant, breastfeeding, or of childbearing potential without contraception.
  • Use of strong CYP3A4 inhibitors or inducers (e.g., protease inhibitors, systemic ketoconazole, rifampin, carbamazepine, phenytoin).
  • Participation in another experimental drug study within the last 30 days. Life expectancy of less than 3 months. History of serious infections within the last 60 days (e.g., bacterial endocarditis, tuberculosis, opportunistic infections).
  • Active substance or alcohol abuse or history of substance dependence within the last year.
  • Positive screening for Hepatitis B surface antigen, Hepatitis C antibody, or known HIV-1 infection.
  • Known coagulation disorders or laboratory abnormalities (e.g., DMID toxicity scale Grade 3 or higher).
  • History of suicidal behavior in the last 6 months or suicidal ideation (C-SSRS type 4 or 5) in the last 2 months.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Behçet's Disease is a systemic inflammatory disorder that can cause vascular complications, including venous thrombosis. Although immunosuppressive therapy is the standard treatment for vascular involvement, the role of anticoagulation remains controversial. This study aims to evaluate whether adding Rivaroxaban to standard immunosuppressive treatment reduces the risk of thrombotic relapse and post-thrombotic syndrome compared to immunosuppressive therapy alone. 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). The study will recruit patients aged 18-50 who have been diagnosed with Behçet's Disease according to International Study Group (ISG) criteria and have a newly diagnosed lower extremity venous thrombosis. Participants will be randomized (1:1) to receive either immunosuppressive therapy with Rivaroxaban or immunosuppressive therapy with a placebo. The treatment duration is 12 months, with follow-up visits at weeks 2, 4, months 2, 3, 6, 9, and 12. The primary outcome is the rate of thrombotic relapse within 52 weeks, assessed by venous Doppler ultrasound. Secondary outcomes include the development of post-thrombotic syndrome (PTS), quality of life measures, and safety assessments, including bleeding complications. The study is sponsored by Health Institutes of Türkiye (TÜSEB) and coordinated by Marmara University, Türkiye. Ethics approval has been obtained from Marmara University Clinical Research Ethics Committee. For further information, please contact the study coordinators.

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 would be randomly assigned to one of two groups and the study is blinded: both groups receive standard immunosuppressive therapy (azathioprine plus a tapered course of methylprednisolone), and one group also receives oral rivaroxaban while the other receives a matching placebo. Treatment lasts 12 months. You would attend clinic visits at baseline, weeks 2 and 4, and months 2, 3, 6, 9, and 12; have Doppler ultrasound scans of the legs at baseline and months 1, 3, 6, 9, and 12; complete clinical assessments for post‑thrombotic syndrome and quality‑of‑life questionnaires; and be monitored for safety issues such as bleeding events.

How the study is structured. Participants are randomized 1:1 into two parallel groups: immunosuppression plus rivaroxaban or immunosuppression plus placebo. The trial is Phase 3 and masked (quadruple-masked/placebo-controlled). Treatment is given for 12 months with scheduled ultrasound and clinic assessments at baseline, week 1 (month 1), week 2, week 4, and months 2, 3, 6, 9, and 12 (the registry lists visits at weeks 2 and 4 and at months 2, 3, 6, 9, and 12).

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 Disease; Behcet Disease and Vascular Involvement; Deep Venous Thromboses; Post Thrombotic Syndrome. Does it apply to my diagnosis?
  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Turkey. 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 familial Mediterranean fever

This trial is also listed on this site under Behçet's disease.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 30, 2025 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Study completion
Apr 1, 2028 (estimated)
Target enrollment
110 participants (estimated)
Last updated on registry
Apr 13, 2025
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
Marmara University
Collaborators
  • Health Institutes of Turkey

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 (2)

  • Marmara University, School of Medicine, Division of Rheumatology

    Istanbul · Turkey (Türkiye)

    • · falibaz@gmail.com
    • Fatma Alibaz Oner, Prof
    • Kerem Abacar, MD
    • Haner Direskeneli, Prof
    • Ahmet Gül, Prof
    • Cemal Bes, Prof
    • Ayten Yazici, Prof
    • Ömer Karadağ, Prof
    • Mehmet Akif Öztürk, Prof
    • Ahmet Omma, Ass. Prof
  • Marmara University

    Istanbul · Turkey (Türkiye)

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.
double-blind
Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled
A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
immunosuppressive
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.
Study Group
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
CT
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.
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.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
corticosteroid
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.
Creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
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.
standard treatment
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
relapse
A condition that improved with treatment and has since returned or worsened.
1:1
How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

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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