An observational study in Behçet's Syndrome, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Istanbul University - Cerrahpasa · Observational
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.
136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.
This study's planned enrollment of 130 is above the median of 90 across 63 observational studies indexed under Behcet Syndrome.
Browse Behcet Syndrome studies →Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
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.
-
Drug: Colchicine
colchicine 1-2 mg/day
Number of oral ulcers
Time frame: 4 weeks
Number of genital ulcers
Time frame: 4 weeks
Number of nodular lesions
Time frame: 4 weeks
Pain of oral ulcers
Time frame: 4 weeks
Pain of genital ulcers
Time frame: 4 weeks
Pain of nodular lesions
Time frame: 4 weeks
Number of papulopustular lesions
Time frame: 4 weeks
Tender joint count
Time frame: 4 weeks
Swollen joint count
Time frame: 4 weeks
Overall disease activity
Overall disease activity will be assessed using Behçet's disease current activity form and Behçet's syndrome activity scale
Time frame: 4 weeks
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
Time frame: 4 weeks
New organ involvement
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul University - Cerrahpasa