Behcet SyndromePhase 3ACTORNCT06780462
Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
A Phase 3 study testing Corticosteroids + Rivaroxaban and Corticosteroids alone in people with Behcet Syndrome, run by Assistance Publique - Hôpitaux de Paris at 17 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- Corticosteroids + Rivaroxaban and Corticosteroids alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 17 sitesFrance
- Study dates
- 24 Jun 2025to 24 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Recruiting
CHU BORDEAUX Hôpital Saint-André
Bordeaux
Emmanuel Ribeiro, +335 56 79 58 28 ext. +33, Emmanuel.ribeiro@chu-bordeaux.fr
- Recruiting
Ambroise Paré hospital AP-HP
Boulogne-Billancourt
Georges Selim Trad, +331 49 09 56 42 ext. +33, salim.trad@aphp.fr
- Recruiting
CHU Caen
Caen
Achille Aouba, +332 31 06 45 79 ext. +33, aouba-a@chu-caen.fr
- Recruiting
Hopital Henri Mondor AP-HP
Créteil
Nicolas Limal, +331 49 81 20 76 ext. +33, nicolas.limal@aphp.fr
- Recruiting
Chu de Grenoble
Grenoble
Alban Deroux, +334 76 76 76 40 ext. +33, aderoux@chu-grenoble.fr
- Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre
Nicolas Noel, +331 45 21 27 57 ext. +33, nicolas.noel@aphp.fr
- Recruiting
Hcl, Hopital de La Croix Rousse
Lyon
Yvan Jamilloux, +334 26 73 26 36 ext. +33, yvan.jamilloux@chu-lyon.fr
- Recruiting
Centre Hospitalier de Melun
Melun
Nabil Belfeki, +331 81 74 18 87 ext. +33, nabil.belfeki@ghsif.fr
- Recruiting
CHRU DE Nancy Hôpitaux de Brabois
Nancy
Thomas Moulinet, +333 83 15 42 51 ext. +33, t.moulinet@chru-nancy.fr
- Recruiting
Hôpital Hôtel-Dieu
Nantes
Olivier Espitia, +332 44 76 80 75 ext. +33, olivier.espitia@chu-nantes.fr
- Recruiting
Hopital Européen Georges Pompidou AP-HP
Paris
Tristan Mirault, +331 56 09 58 32 ext. +33, tristan.mirault@aphp.fr
- Recruiting
Hôpital Lariboisière AP-HP
Paris
Chloé Comarmond, +331 49 95 63 21, chloe.comarmondortoli@aphp.fr
- Recruiting
Hôpital Saint Antoine AP-HP
Paris
Arsène Mekinian, +331 71 97 07 65, arsene.mekinian@aphp.fr
- Recruiting
Hôpital Tenon AP-HP
Paris
Léa Savey, +331 56 01 67 91 ext. +33, lea.savey@aphp.fr
- Recruiting
La Pitié Salpetriere hospital
Paris
David Saadoun, MD PhD, +33142178042 ext. +33, david.saadoun@psl.aphp.fr
- Recruiting
CHU Bordeaux- GHU SUD hôpital Haut-Lévêque
Pessac
Estibaliz Lazaro, +335 57 65 64 83 ext. +33, estibaliz.lazaro@chu-bordeaux.fr
- Recruiting
CHU DE ROUEN, Hôpital CHARLES NICOLLE
Rouen
Mathilde Leclercq, +332 32 88 90 03 ext. +33, Mathilde.leclercq@chu-rouen.fr
About this study
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.
- Conditions
- Behcet Syndrome
- Being tested
- Corticosteroids + Rivaroxaban, Corticosteroids alone
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids + RivaroxabanDrug
Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market) and Rivaroxaban
Corticosteroids aloneDrug
Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market)
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids and Rivaroxaban | Experimental | Not described Receives: Drug: Corticosteroids + Rivaroxaban |
| Corticosteroids alone | Active comparator | Not described Receives: Drug: Corticosteroids alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of success
Defined as absence of deep venous thrombosis relapse and of major bleeding event, without introduction of additional immunosuppressive medication for BS activity other than thrombotic events at 6 months.
Measured: At 6 months
Secondary outcomes (40)
Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse
Measured: At 12 months
Cumulative incidence of major venous thrombosis
pulmonary embolism, vena cava , Budd Chiari syndrome , intra-cardiac relapse
Measured: At 12 months
Cumulative incidence of venous repermeabilization
assessed by vascular imaging
Measured: At 6 months
Proportion of patients with a dose ≤ 5 mg/day of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 6 months
Proportion of patients with a dose ≤ 5 mg/day of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 12 months
Dose of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 3 months
Dose of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 6 months
Dose of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 12 months
Cumulative dose of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 3 months
Cumulative dose of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 6 months
Cumulative dose of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Measured: At 12 months
Cumulative incidence of major bleeding event
Measured: At 12 months
Cumulative incidence of bleeding event
Measured: At 12 months
Number of adverse events
Measured: At 3 months
Number of adverse events
Measured: At 6 months
Number of adverse events
Measured: At 12 months
Change in SF-36 quality-of-life
The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Measured: At 3 months
Change in SF-36 quality-of-life
The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Measured: At 6 months
Change in SF-36 quality-of-life
The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Measured: At 12 months
Change in Behçet's Disease Current Activity Form
It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease.
Measured: At 3 months
Change in Behçet's Disease Current Activity Form
It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease.
Measured: At 6 months
Change in Behçet's Disease Current Activity Form
It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease.
Measured: At 12 months
Change in Behçet's Syndrome Assessment Score
It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease.
Measured: At 3 months
Change in Behçet's Syndrome Assessment Score
It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease.
Measured: At 6 months
Change in Behçet's Syndrome Assessment Score
It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease.
Measured: At 12 months
Change in Physician Global Assessment
Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease.
Measured: At 3 months
Change in Physician Global Assessment
Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease.
Measured: At 6 months
Change in Physician Global Assessment
Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease.
Measured: At 12 months
Overall survival
Measured: At 12 months
Event free survival
Measured: At 12 months
Proportion of post thrombotic syndrome
According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms
Measured: At 12 months
Changes in Villalta's post-thrombotic syndrome scale
According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms
Measured: At 6 months
Changes in Villalta's post-thrombotic syndrome scale
According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms
Measured: At 12 months
Proportion of remission
According to other organs involved
Measured: At 3 months
Proportion of remission
According to other organs involved
Measured: At 6 months
Proportion of remission
According to other organs involved
Measured: At 12 months
Changes in acute-phase reactants
Measured: At 1 month
Changes in acute-phase reactants
Measured: At 3 months
Changes in acute-phase reactants
Measured: At 6 months
Changes in acute-phase reactants
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start24 Jun 2025
- Primary completion24 Dec 2027 (estimated)
- Study completion24 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised, controlled, multicentre, superiority study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780462
- Sponsor's protocol ID
- APHP220673
- Acronym
- ACTOR
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
- ClinicalTrials.gov ID
- NCT06780462
- Acronym / sponsor ID
- ACTOR / APHP220673
- Conditions
- Behcet Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 24 Dec 2027 (estimated)
- Study completion
- 24 Jun 2028 (estimated)
- First posted
- 17 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, controlled, multicentre, superiority study
| Arm | Type | Receives |
|---|---|---|
| Corticosteroids and Rivaroxaban | Experimental | Drug: Corticosteroids + Rivaroxaban |
| Corticosteroids alone | Active comparator | Drug: Corticosteroids alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Corticosteroids + RivaroxabanCorticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market) and Rivaroxaban | Drug | Corticosteroids and Rivaroxaban |
| Corticosteroids aloneCorticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market) | Drug | Corticosteroids alone |
Primary outcome
Rate of success
Time frame: At 6 months
Defined as absence of deep venous thrombosis relapse and of major bleeding event, without introduction of additional immunosuppressive medication for BS activity other than thrombotic events at 6 months.
40 secondary outcomes
Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse
Time frame: At 12 months
Cumulative incidence of major venous thrombosis
Time frame: At 12 months
Cumulative incidence of venous repermeabilization
Time frame: At 6 months
Proportion of patients with a dose ≤ 5 mg/day of prednisone
Time frame: At 6 months
Proportion of patients with a dose ≤ 5 mg/day of prednisone
Time frame: At 12 months
Dose of prednisone
Time frame: At 3 months
Dose of prednisone
Time frame: At 6 months
Dose of prednisone
Time frame: At 12 months
Cumulative dose of prednisone
Time frame: At 3 months
Cumulative dose of prednisone
Time frame: At 6 months
Cumulative dose of prednisone
Time frame: At 12 months
Cumulative incidence of major bleeding event
Time frame: At 12 months
Cumulative incidence of bleeding event
Time frame: At 12 months
Number of adverse events
Time frame: At 3 months
Number of adverse events
Time frame: At 6 months
Number of adverse events
Time frame: At 12 months
Change in SF-36 quality-of-life
Time frame: At 3 months
Change in SF-36 quality-of-life
Time frame: At 6 months
Change in SF-36 quality-of-life
Time frame: At 12 months
Change in Behçet's Disease Current Activity Form
Time frame: At 3 months
Change in Behçet's Disease Current Activity Form
Time frame: At 6 months
Change in Behçet's Disease Current Activity Form
Time frame: At 12 months
Change in Behçet's Syndrome Assessment Score
Time frame: At 3 months
Change in Behçet's Syndrome Assessment Score
Time frame: At 6 months
Change in Behçet's Syndrome Assessment Score
Time frame: At 12 months
Change in Physician Global Assessment
Time frame: At 3 months
Change in Physician Global Assessment
Time frame: At 6 months
Change in Physician Global Assessment
Time frame: At 12 months
Overall survival
Time frame: At 12 months
Event free survival
Time frame: At 12 months
Proportion of post thrombotic syndrome
Time frame: At 12 months
Changes in Villalta's post-thrombotic syndrome scale
Time frame: At 6 months
Changes in Villalta's post-thrombotic syndrome scale
Time frame: At 12 months
Proportion of remission
Time frame: At 3 months
Proportion of remission
Time frame: At 6 months
Proportion of remission
Time frame: At 12 months
Changes in acute-phase reactants
Time frame: At 1 month
Changes in acute-phase reactants
Time frame: At 3 months
Changes in acute-phase reactants
Time frame: At 6 months
Changes in acute-phase reactants
Time frame: At 12 months
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 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
17 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 Corticosteroids + Rivaroxaban and Corticosteroids alone in people with Behcet Syndrome, run by Assistance Publique - Hôpitaux de Paris at 17 sites in France.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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. 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 David Saadoun, MD PhD (0142178042 ext. +33, david.saadoun@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success (time frame: At 6 months). 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 23 Apr 2026.