Behcet DiseasePhase 3BETTERNCT06925698
Immunosuppressive Therapy Alone Versus Plus Oral Anticoagulation in the Treatment of VT Associated With Behcet's Disease
A Phase 3 study testing Rivaroxaban plus immunosupression in people with Behcet Disease and Behcet Disease and Vascular Involvement, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Behcet Disease, Behcet Disease and Vascular Involvement, Deep Venous Thromboses
- What is being tested?
- Rivaroxaban plus immunosupression
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 1 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Marmara University, School of Medicine, Division of Rheumatology
Istanbul
falibaz@gmail.com
Fatma Alibaz Oner, Prof
Marmara University
Istanbul
About this study
Official title: Immunosuppressive Therapy Alone Versus Immunosuppressive Therapy Plus Oral Anticoagulation in the Treatment of Lower Extremity Venous Thrombosis Associated With Behcet's Disease
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).
Read the detailed description
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.
- Conditions
- Behcet Disease, Behcet Disease and Vascular Involvement, Deep Venous Thromboses, Post Thrombotic Syndrome
- Being tested
- Placebo plus immunosuppression, Rivaroxaban plus immunosupression
- Keywords
- Behcet's disease, Deep venous thrombosis, Anticoagulant therapy, Rivaroxaban
- Medical subject headings
- Behcet Syndrome, Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo plus immunosuppressionDrug
Participants in this arm will receive placebo plus standard immunosuppressive therapy consisting of:
Azathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol) This intervention represents the standard treatment for venous thrombosis associated with Behçet's Disease and serves as the control arm of the study.
Rivaroxaban plus immunosupressionDrug
Participants in this arm will receive standard immunosuppressive therapy as described above, plus Rivaroxaban (20 mg/day, oral, for 12 months).
This intervention aims to evaluate whether the addition of oral anticoagulation (Rivaroxaban) to immunosuppressive therapy reduces the risk of thrombotic relapse and post-thrombotic syndrome compared to immunosuppressive therapy alone.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppressive Therapy + Placebo | Placebo comparator | Azathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol) + Placebo Receives: Drug: Placebo plus immunosuppression |
| Immunosuppressive Therapy + Rivaroxaban | Active comparator | Azathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol), plus Rivaroxaban (20 mg/day, oral, for 12 months) Receives: Drug: Rivaroxaban plus immunosupression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Thrombotic Relapse at 52 Weeks
The primary outcome is the rate of thrombotic relapse within 52 weeks, assessed via lower extremity venous Doppler ultrasound.
Thrombotic relapse is defined as:
A new thrombotic event in a previously unaffected ipsilateral or contralateral vein.
Re-thrombosis in a previously affected vein that was classified as well-recanalized (≥50% compressibility on Doppler ultrasound).
Venous Doppler ultrasound assessments will be performed at baseline, months 1, 3, 6, 9, and 12.
Measured: 52 weeks
Secondary outcomes (3)
Development of Post-Thrombotic Syndrome (PTS) at 52 Weeks
The occurrence of Post-Thrombotic Syndrome (PTS) will be assessed using standardized clinical scoring systems, including:
Villalta Scale (PTS severity assessment) Venous Clinical Severity Score (VCSS) Venous Disability Score (VDS) Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) PTS is defined as a Villalta score ≥5 or the presence of a venous ulcer.
Measured: 52 weeks
Rate of Venous Recanalization at 52 Weeks
Venous recanalization will be assessed via Doppler ultrasound to evaluate the extent of clot resolution in affected veins.
Partial or complete recanalization will be determined based on compressibility and flow characteristics.
Measured at baseline, months 1, 3, 6, 9, and 12.
Measured: 52 weeks
Incidence of Major and Clinically Relevant Non-Major Bleeding Events
The frequency of major bleeding (as per ISTH criteria) and clinically relevant non-major bleeding will be recorded.
Major bleeding:
- 2.0 g/dL hemoglobin drop
- 2 units of red blood cell transfusion Intracranial, retroperitoneal, or fatal bleeding
Clinically relevant non-major bleeding:
Epistaxis >5 minutes, spontaneous hematomas >25 cm², gastrointestinal bleeding not meeting major criteria.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, prospective, randomized, double-blind, placebo-controlled, Phase III clinical trial designed to evaluate the efficacy and safety of immunosuppressive therapy alone versus immunosuppressive therapy plus oral anticoagulation (Rivaroxaban) in the treatment of venous thrombosis associated with Behçet's Disease. Participants will be randomized (1:1) into two groups: Immunosuppressive therapy alone Immunosuppressive therapy plus Rivaroxaban (20 mg/day, oral) The treatment duration is 12 months, with follow-up visits at weeks 2, 4, months 2, 3, 6, 9, and 12. The study employs a double-blind design, meaning that both participants and investigators are blinded to treatment allocation. Randomization is stratified by gender to ensure balanced distribution. The primary endpoint is the rate of thrombotic relapse within 52 weeks, assessed via venous Doppler ultrasound. Secondary outcomes include post-thrombotic syndrome development, quality of life measures, and safety ass
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor
- Investigators
- Fatma Alibaz-Oner, Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925698
- Sponsor's protocol ID
- 09.2023.1733
- Acronym
- BETTER
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure patient confidentiality and compliance with data protection regulations
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressive Therapy Alone Versus Immunosuppressive Therapy Plus Oral Anticoagulation in the Treatment of Lower Extremity Venous Thrombosis Associated With Behcet's Disease
- ClinicalTrials.gov ID
- NCT06925698
- Acronym / sponsor ID
- BETTER / 09.2023.1733
- Conditions
- Behcet Disease, Behcet Disease and Vascular Involvement, Deep Venous Thromboses, Post Thrombotic Syndrome
- Keywords
- Behcet's disease, Deep venous thrombosis, Anticoagulant therapy, Rivaroxaban
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter, prospective, randomized, double-blind, placebo-controlled, Phase III clinical trial designed to evaluate the efficacy and safety of immunosuppressive therapy alone versus immunosuppressive therapy plus oral anticoagulation (Rivaroxaban) in the treatment of venous thrombosis associated with Behçet's Disease. Participants will be randomized (1:1) into two groups: Immunosuppressive therapy alone Immunosuppressive therapy plus Rivaroxaban (20 mg/day, oral) The treatment duration is 12 months, with follow-up visits at weeks 2, 4, months 2, 3, 6, 9, and 12. The study employs a double-blind design, meaning that both participants and investigators are blinded to treatment allocation. Randomization is stratified by gender to ensure balanced distribution. The primary endpoint is the rate of thrombotic relapse within 52 weeks, assessed via venous Doppler ultrasound. Secondary outcomes include post-thrombotic syndrome development, quality of life measures, and safety ass
| Arm | Type | Receives |
|---|---|---|
| Immunosuppressive Therapy + Placebo | Placebo comparator | Drug: Placebo plus immunosuppressionAzathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol) + Placebo |
| Immunosuppressive Therapy + Rivaroxaban | Active comparator | Drug: Rivaroxaban plus immunosupressionAzathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol), plus Rivaroxaban (20 mg/day, oral, for 12 months) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (17 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo plus immunosuppressionParticipants in this arm will receive placebo plus standard immunosuppressive therapy consisting of: Azathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol) This intervention represents the standard treatment for venous thrombosis associated with Behçet's Disease and serves as the control arm of the study. | Drug | Immunosuppressive Therapy + Placebo |
| Rivaroxaban plus immunosupressionParticipants in this arm will receive standard immunosuppressive therapy as described above, plus Rivaroxaban (20 mg/day, oral, for 12 months). This intervention aims to evaluate whether the addition of oral anticoagulation (Rivaroxaban) to immunosuppressive therapy reduces the risk of thrombotic relapse and post-thrombotic syndrome compared to immunosuppressive therapy alone. | Drug | Immunosuppressive Therapy + Rivaroxaban |
Primary outcome
Rate of Thrombotic Relapse at 52 Weeks
Time frame: 52 weeks
The primary outcome is the rate of thrombotic relapse within 52 weeks, assessed via lower extremity venous Doppler ultrasound. Thrombotic relapse is defined as: A new thrombotic event in a previously unaffected ipsilateral or contralateral vein. Re-thrombosis in a previously affected vein that was classified as well-recanalized (≥50% compressibility on Doppler ultrasound). Venous Doppler ultrasound assessments will be performed at baseline, months 1, 3, 6, 9, and 12.
3 secondary outcomes
Development of Post-Thrombotic Syndrome (PTS) at 52 Weeks
Time frame: 52 weeks
Rate of Venous Recanalization at 52 Weeks
Time frame: 52 weeks
Incidence of Major and Clinically Relevant Non-Major Bleeding Events
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure patient confidentiality and compliance with data protection regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma Alibaz-Oner, Prof principal investigator
Marmara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban plus immunosupression in people with Behcet Disease and Behcet Disease and Vascular Involvement, run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Alibaz-Oner, Prof (+90 216 625 45 45, falibaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Thrombotic Relapse at 52 Weeks (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.