Prednisone for Behçet's syndrome | Deep venous thrombosis

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)."}
• {"criterion_text":"- Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Severe renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy"}
• {"criterion_text":"- Platelet count < 50 x 103/mm3"}
• {"criterion_text":"- Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit."}
• {"criterion_text":"- Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))"}
• {"criterion_text":"- Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study"}

Primary endpoints

• {"endpoint_text":"- Rate of success defined as absence of deep venous thrombosis relapse and major bleeding event, without introduction of additional immunosuppressive medication for BS venous activity at 6 months and following the glucocorticoids tapering.","definition_or_measurement_approach":"Success measured as absence of DVT relapse and absence of major bleeding, and no introduction of additional immunosuppressive medication for Behçet's venous activity, assessed at 6 months following glucocorticoid tapering."}

Secondary endpoints

• {"endpoint_text":"- Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse within 12 months from randomization","definition_or_measurement_approach":"Cumulative incidence of DVT and superficial venous thrombosis relapse within 12 months from randomization (see definition in section 4.1.1 of the protocol)."}
• {"endpoint_text":"- Cumulative incidence of major venous thrombosis (i.e other than limbs) relapse within 12 months from randomization","definition_or_measurement_approach":"Cumulative incidence of relapse of major venous thrombosis (other than limbs) within 12 months from randomization."}
• {"endpoint_text":"- Cumulative incidence of venous repermeabilization, assessed by vascular imaging at 6 months. The following ultrasound criteria will be used to determine the absence of repermeabilization flow: partial compressibility of the vein, diminution of the vessel diameter, heterogeneous and hyperechoic thrombus, multiple channels of flow inside the veins, reflux, and collateral circulation.","definition_or_measurement_approach":"Venous repermeabilization assessed by vascular imaging at 6 months using ultrasound criteria: absence of repermeabilization flow defined by partial compressibility, decreased vessel diameter, heterogeneous/hyperechoic thrombus, multiple intraluminal flow channels, reflux, and collateral circulation."}
• {"endpoint_text":"- Femoral and popliteal vein reflux is defined as retrograde flow > 1 s after calf and thigh compression release while the patient was in the standing position","definition_or_measurement_approach":"Femoral and popliteal vein reflux measured as retrograde flow >1 second after calf and thigh compression release with patient standing."}
• {"endpoint_text":"- Measures of corticosteroid sparing: Proportion of patients with a dose ≤ 5 mg/day of prednisone at 6, and 12 months. (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market). Dose at 3, 6 and 12 months. Cumulative dose at 3, 6, and 12 months","definition_or_measurement_approach":"Corticosteroid-sparing measured by proportion of patients on ≤5 mg/day prednisone at 6 and 12 months, prednisone-equivalent doses at 3, 6, and 12 months, and cumulative dose at those timepoints."}
• {"endpoint_text":"- Cumulative incidence of major bleeding event within 12 months from randomization","definition_or_measurement_approach":"Cumulative incidence of major bleeding events within 12 months from randomization (see protocol section 4.1.1 for definitions)."}
• {"endpoint_text":"- Cumulative incidence of bleeding event within 12 months from randomization","definition_or_measurement_approach":"Cumulative incidence of bleeding events within 12 months from randomization."}
• {"endpoint_text":"- Adverse events (counts, proportions) at 3, 6, and 12 months","definition_or_measurement_approach":"Adverse events reported as counts and proportions at 3, 6, and 12 months."}
• {"endpoint_text":"- Change in SF-36 quality-of-life at 3, 6, and 12 months, from baseline","definition_or_measurement_approach":"Change from baseline in SF-36 quality-of-life scores at 3, 6, and 12 months."}
• {"endpoint_text":"- Change in Behçet's Disease activity scores BDCAF, BSAS and Physician Global Assessment (PhGA) at 3, 6, and 12 months","definition_or_measurement_approach":"Change from baseline in BDCAF, BSAS and PhGA scores at 3, 6, and 12 months."}
• {"endpoint_text":"- Overall Survival and event-free-survival within 12 months from randomization","definition_or_measurement_approach":"Overall survival and event-free survival measured within 12 months from randomization."}
• {"endpoint_text":"- Proportion of post thrombotic syndrome according to Villalta’s post-thrombotic syndrome scale and mean changes in Villalta’s post-thrombotic syndrome scale at 6, and 12 months","definition_or_measurement_approach":"Proportion with post-thrombotic syndrome and mean change in Villalta score at 6 and 12 months, assessed using Villalta’s post-thrombotic syndrome scale."}
• {"endpoint_text":"- Proportion of remission according to other organs involved at 3, 6, and 12 months","definition_or_measurement_approach":"Proportion of remission for involvement of other organs at 3, 6, and 12 months."}
• {"endpoint_text":"- Changes in acute-phase reactants at 1, 3, 6, and 12 months","definition_or_measurement_approach":"Changes from baseline in acute-phase reactants measured at 1, 3, 6, and 12 months."}

France

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

06-03-2025

Processing Time Days

135

Number Of Sites

17

Number Of Participants

134

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France