Clinical trial NCT06146192: Withdrawal of Colchicine in Behçet Syndrome
Official title: Withdrawal of Colchicine in Behçet Syndrome Patients With Skin and Mucosa Involvement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Behçet's Syndrome
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Behçet's syndrome patients with mucocutaneous involvement who have been using colchicine at a stable dose (1-2 mg/day) during the last 3 months and who do not have any active organ involvement (ie uveitis, venous thrombosis, arterial aneurysms or thrombosis, nervous system involvement, and gastrointestinal involvement).

Brief summary: 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.


Eligibility criteria: 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.

-

Primary outcomes:
measure: Number of oral ulcers
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of genital ulcers
timeFrame: 4 weeks
measure: Number of nodular lesions
timeFrame: 4 weeks
measure: Pain of oral ulcers
timeFrame: 4 weeks
measure: Pain of genital ulcers
timeFrame: 4 weeks
measure: Pain of nodular lesions
timeFrame: 4 weeks
measure: Number of papulopustular lesions
timeFrame: 4 weeks
measure: Tender joint count
timeFrame: 4 weeks
measure: Swollen joint count
timeFrame: 4 weeks
measure: Overall disease activity
timeFrame: 4 weeks
measure: Health related quality of life
timeFrame: 4 weeks
measure: New organ involvement
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: