Withdrawal of Colchicine in Behçet Syndrome

Istanbul University - Cerrahpasa (IUC)

Status: Not yet enrolling

Conditions: Behçet's Syndrome

Treatments: Drug: Colchicine

Study type: Observational

Funder types: Other

Identifiers

NCT06146192

431693

Details and patient eligibility

About

Behçet's syndrome is a multisystem variable vessel vasculitis. Clinical features include mucocutaneous manifestions such as oral ulcers, genital ulcers, papulopustular lesions and nodular lesions, musculoskeletal manifestations, uveitis, venous thrombosis, arterial aneurysms and thrombosis, central nervous system involvement and gastrointestinal involvement. Management of Behçet's syndrome depends on the type of organ involvement, disease severity, and prognostic factors. The main objective in patients with major organ involvement is to rapidly suppress the inflammation and prevent relapses in order to prevent organ damage. On the other hand, mucocutaneous and musculoskeletal manifestations do not cause damage and in patients with only mucocutaneous and joint involvement, the aim is to improve the quality of life.

Colchicine is usually the first-line systemic treatment in patients with only mucocutaneous and joint involvement. Conflicting results were reported on the efficacy of colchicine on different mucocutaneous manifestations in randomized placebo-controlled trials. The relapsing and remitting nature of these manifestations in Behçet's syndrome may cause challenges in disease assessment during clinical trials. Another approach to evaluate the effectiveness of a medication is to evaluate whether the lesions recur or increase after discontinuation of the drug. The aim of this study is to assess mucocutaneous disease activity among Behçet's syndrome patients after discontinuation of colchicine treatment and compare it to patients who continue to use colchicine.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Fulfilling International Study Group criteria. Being between the ages of 18 and 65 years. Having mucocutaneous involvement. Using colchicine at a stable dose (1-2 mg/day) for at least 3 months. Showing no adverse events related to colchicine use. Providing informed consent to participate in the study. -

Exclusion criteria

Patients with active uveitis. Patients with active venous involvement. Patients with active arterial involvement. Patients with active nervous system involvement. Patients with active gastrointestinal involvement.

Trial design

130 participants in 2 patient groups

Colchicine

Treatment:

Drug: Colchicine

No colchicine