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RecruitingNCT06780462ACTORUpdated Apr 23, 2026

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

A Phase 3 interventional study of Corticosteroids + Rivaroxaban and Corticosteroids alone in Behcet Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Behcet Syndrome

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03

In context

Behcet Syndrome

136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's planned enrollment of 134 is above the median of 50 across 70 interventional studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old
  2. Diagnosis of BS according to the international criteria
  3. First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
  4. Written inform consent
  5. 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).
  6. Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study

Exclusion criteria

Exclusion Criteria:

  1. Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)
  2. Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
  3. Isolated superficial thrombosis without concomitant deep venous thrombosis.
  4. Pregnancy or lactation
  5. 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
  6. Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion
  7. Severe chronic renal (creatinine clearance \<30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
  8. Platelet count \< 50 x 103/mm3
  9. Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit.
  10. Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
  11. Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    Corticosteroids and Rivaroxaban

    Drug: Corticosteroids + Rivaroxaban

  • Active comparator
    Corticosteroids alone

    Drug: Corticosteroids alone

Interventions

  • DrugCorticosteroids + Rivaroxaban

    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

  • DrugCorticosteroids alone

    Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 6 months

Secondary outcomes

  1. Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse

    Time frame: At 12 months

  2. Cumulative incidence of major venous thrombosis

    pulmonary embolism, vena cava , Budd Chiari syndrome , intra-cardiac relapse

    Time frame: At 12 months

  3. Cumulative incidence of venous repermeabilization

    assessed by vascular imaging

    Time frame: At 6 months

  4. 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)

    Time frame: At 6 months

  5. 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)

    Time frame: At 12 months

  6. Dose of prednisone

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

    Time frame: At 3 months

  7. Dose of prednisone

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

    Time frame: At 6 months

  8. Dose of prednisone

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

    Time frame: At 12 months

  9. Cumulative dose of prednisone

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

    Time frame: At 3 months

  10. Cumulative dose of prednisone

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

    Time frame: At 6 months

  11. Cumulative dose of prednisone

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

    Time frame: At 12 months

  12. Cumulative incidence of major bleeding event

    Time frame: At 12 months

  13. Cumulative incidence of bleeding event

    Time frame: At 12 months

  14. Number of adverse events

    Time frame: At 3 months

  15. Number of adverse events

    Time frame: At 6 months

  16. Number of adverse events

    Time frame: At 12 months

  17. 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.

    Time frame: At 3 months

  18. 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.

    Time frame: At 6 months

  19. 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.

    Time frame: At 12 months

  20. 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.

    Time frame: At 3 months

  21. 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.

    Time frame: At 6 months

  22. 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.

    Time frame: At 12 months

  23. 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.

    Time frame: At 3 months

  24. 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.

    Time frame: At 6 months

  25. 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.

    Time frame: At 12 months

  26. 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.

    Time frame: At 3 months

  27. 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.

    Time frame: At 6 months

  28. 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.

    Time frame: At 12 months

  29. Overall survival

    Time frame: At 12 months

  30. Event free survival

    Time frame: At 12 months

  31. 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

    Time frame: At 12 months

  32. 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

    Time frame: At 6 months

  33. 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

    Time frame: At 12 months

  34. Proportion of remission

    According to other organs involved

    Time frame: At 3 months

  35. Proportion of remission

    According to other organs involved

    Time frame: At 6 months

  36. Proportion of remission

    According to other organs involved

    Time frame: At 12 months

  37. Changes in acute-phase reactants

    Time frame: At 1 month

  38. Changes in acute-phase reactants

    Time frame: At 3 months

  39. Changes in acute-phase reactants

    Time frame: At 6 months

  40. Changes in acute-phase reactants

    Time frame: At 12 months

07

Study locations

17 of 17 sites recruiting
  • CHU BORDEAUX Hôpital Saint-André
    Bordeaux, France
    Recruiting
  • Ambroise Paré hospital AP-HP
    Boulogne-Billancourt, France
    Recruiting
  • CHU Caen
    Caen, France
    Recruiting
  • Hopital Henri Mondor AP-HP
    Créteil, France
    Recruiting
  • Chu de Grenoble
    Grenoble, France
    Recruiting
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • Hcl, Hopital de La Croix Rousse
    Lyon, France
    Recruiting
  • Centre Hospitalier de Melun
    Melun, France
    Recruiting
  • CHRU DE Nancy Hôpitaux de Brabois
    Nancy, France
    Recruiting
  • Hôpital Hôtel-Dieu
    Nantes, France
    Recruiting
  • Hopital Européen Georges Pompidou AP-HP
    Paris, France
    Recruiting
  • Hôpital Lariboisière AP-HP
    Paris, France
    Recruiting
  • Hôpital Saint Antoine AP-HP
    Paris, France
    Recruiting
  • Hôpital Tenon AP-HP
    Paris, France
    Recruiting
  • La Pitié Salpetriere hospital
    Paris, France
    Recruiting
  • CHU Bordeaux- GHU SUD hôpital Haut-Lévêque
    Pessac, France
    Recruiting
  • CHU DE ROUEN, Hôpital CHARLES NICOLLE
    Rouen, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06780462
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
Jun 24, 2025
Primary completion
Dec 24, 2027 (estimated)
Completion
Jun 24, 2028 (estimated)
Last update
Apr 23, 2026

Study contacts

David Saadoun, MD PhD
Contact
david.saadoun@psl.aphp.fr
0142178042 ext. +33
Jérôme Lambert, MD PhD
Contact
jerome.lambert@u-paris.fr
0142499742 ext. +33

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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