Behçet's SyndromeNCT06146192
Withdrawal of Colchicine in Behçet Syndrome
An observational study of Behçet's Syndrome, run by Istanbul University - Cerrahpasa.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Behçet's Syndrome
- What is being tested?
- Colchicine
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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. -
Who cannot join
- 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.
- -
About this study
Official title: Withdrawal of Colchicine in Behçet Syndrome Patients With Skin and Mucosa Involvement
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.
- Conditions
- Behçet's Syndrome
- Being tested
- Colchicine
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
colchicine 1-2 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Not described Receives: Drug: Colchicine | |
| No colchicine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oral ulcers
Measured: 4 weeks
Secondary outcomes (11)
Number of genital ulcers
Measured: 4 weeks
Number of nodular lesions
Measured: 4 weeks
Pain of oral ulcers
Measured: 4 weeks
Pain of genital ulcers
Measured: 4 weeks
Pain of nodular lesions
Measured: 4 weeks
Number of papulopustular lesions
Measured: 4 weeks
Tender joint count
Measured: 4 weeks
Swollen joint count
Measured: 4 weeks
Overall disease activity
Overall disease activity will be assessed using Behçet's disease current activity form and Behçet's syndrome activity scale
Measured: 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
Measured: 4 weeks
New organ involvement
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start20 Nov 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulen Hatemi, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146192
- Sponsor's protocol ID
- 431693
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal of Colchicine in Behçet Syndrome Patients With Skin and Mucosa Involvement
- ClinicalTrials.gov ID
- NCT06146192
- Acronym / sponsor ID
- 431693
- Conditions
- Behçet's Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Nov 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | – | Drug: Colchicine |
| No colchicine | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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. -
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicinecolchicine 1-2 mg/day | Drug | Colchicine |
Primary outcome
Number of oral ulcers
Time frame: 4 weeks
11 secondary outcomes
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
Time frame: 4 weeks
Health related quality of life
Time frame: 4 weeks
New organ involvement
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Yes
Related trials for Behçet's Syndrome
RecruitingPhase 3
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Serum EBI-3 Protein Levels in Behçet's Disease
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Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
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RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet's Syndrome, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oral ulcers (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.