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Withdrawal of Colchicine in Behçet Syndrome

NCT ID: NCT06146192

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Behçet's Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Colchicine

Colchicine

Intervention Type DRUG

colchicine 1-2 mg/day

No colchicine

No interventions assigned to this group

Interventions

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Colchicine

colchicine 1-2 mg/day

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Gulen Hatemi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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431693

Identifier Type: -

Identifier Source: org_study_id