Withdrawal of Colchicine in Behçet Syndrome

Behçet's Syndrome Clinical Trial

Official title:

Withdrawal of Colchicine in Behçet Syndrome Patients With Skin and Mucosa Involvement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06146192
• Other study ID #: 431693
• Status: Not yet recruiting
• Start date: November 20, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 1, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Behcet Syndrome
• Behçet's Syndrome
• Syndrome

Intervention

Drug:
• Colchicine
colchicine 1-2 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oral ulcers		4 weeks
Secondary	Number of genital ulcers		4 weeks
Secondary	Number of nodular lesions		4 weeks
Secondary	Pain of oral ulcers		4 weeks
Secondary	Pain of genital ulcers		4 weeks
Secondary	Pain of nodular lesions		4 weeks
Secondary	Number of papulopustular lesions		4 weeks
Secondary	Tender joint count		4 weeks
Secondary	Swollen joint count		4 weeks
Secondary	Overall disease activity	Overall disease activity will be assessed using Behçet's disease current activity form and Behçet's syndrome activity scale	4 weeks
Secondary	Health related quality of life	Health related quality of life will be assessed using short form 36 V2 and Behçet's disease quality of life scale	4 weeks
Secondary	New organ involvement		4 weeks