Withdrawal of Colchicine in Behçet Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Colchicine
|
Drug: Colchicine
colchicine 1-2 mg/day
|
| No colchicine
|
Outcome Measures
Primary Outcome Measures
- Number of oral ulcers [4 weeks]
Secondary Outcome Measures
- Number of genital ulcers [4 weeks]
- Number of nodular lesions [4 weeks]
- Pain of oral ulcers [4 weeks]
- Pain of genital ulcers [4 weeks]
- Pain of nodular lesions [4 weeks]
- Number of papulopustular lesions [4 weeks]
- Tender joint count [4 weeks]
- Swollen joint count [4 weeks]
- Overall disease activity [4 weeks]
Overall disease activity will be assessed using Behçet's disease current activity form and Behçet's syndrome activity scale
- Health related quality of life [4 weeks]
Health related quality of life will be assessed using short form 36 V2 and Behçet's disease quality of life scale
- New organ involvement [4 weeks]
Eligibility Criteria
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.
-
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Istanbul University - Cerrahpasa (IUC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 431693