Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	The complete remission rate of oral ulcers in subjects after 12 weeks of treatment	12 weeks	A complete remission at week 12 was defined as participants who were oral ulcer-free at week 12.
Secondary	Percentage of participants who had an partial response of oral ulcer at Week 12	12 weeks	A partial response at week 12 was defined as participants with a 50% or more reduction in the number of oral ulcers at week 12
Secondary	Percentage of participants who had no response of oral ulcer at Week 12	12 weeks	No response at week 12 was defined as all other participants at week 12
Secondary	Percentage of participants who had a complete response of genital ulcer at Week 12	12 weeks	A complete remission at week 12 was defined as participants who were genital ulcer-free at week 12.
Secondary	Percentage of participants who had an partial response of genital ulcer at Week 12	12 weeks	A partial response at week 12 was defined as participants with a 50% or more reduction in the number of genital ulcers at week 12
Secondary	Percentage of participants who had no response of genital ulcer at Week 12	12 weeks	No response at week 12 was defined as all other participants at week 12
Secondary	Change from baseline on oral ulcer pain as measured by visual analogue scale (VAS) at week 12	Baseline to week 12	Pain of oral ulcers was measured using a 100 mm VAS scale. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was recorded. A negative change from baseline indicates improvement.
Secondary	Change from baseline on genital ulcer pain as measured by visual analogue scale (VAS) at week 12	Baseline to week 12	Pain of genital ulcers was measured using a 100 mm VAS scale. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was recorded. A negative change from baseline indicates improvement.
Secondary	Change from baseline in disease activity as measured by Behçet's Disease Current Activity Form (BDCAF)	Baseline to week 12	The Behçet's Disease Current Activity Form (BDCAF) consists of 3 component scores: the Behçet's Disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity. The BDCAI consists of 12 questions regarding disease manifestations over the previous 4 weeks, The score is the sum score of 12 items and ranges from 0 to 12. A higher score indicates a higher level of disease activity, and a negative change from baseline indicates improvement. The Patient's Perception of Disease Activity was assessed on a scale from 1 to 7, and the Clinician's Overall Perception of Disease Activity was assessed on a scale from 1 to 7. A higher score indicates a higher level of disease activity and a negative change from baseline indicates improvement.
Secondary	Change from baseline in disease activity as measured by Behçet's Syndrome Activity Score (BSAS) at Week 12	Baseline to week 12	The Behçet's Syndrome Activity Score (BSAS) contains 10 questions that assess the number of new oral and genital ulcers and skin lesions, GI, CNS, vascular, and ocular involvement, and the participant's current level of discomfort. The Behçet's Syndrome Activity Score ranges from 0 to 100, with a higher score indicating a higher level of disease activity. A negative change from baseline indicates improvement.
Secondary	Change from baseline in Behçet's Disease Quality of Life (BD Qol) Scores at week 12	Baseline to week 12	The Behçet's Disease Quality of Life questionnaire was developed to measure the influence of BD on a particpant's life. It consists of 30 self-completed itemized questions that measure disease- related restrictions on the participant's activities and their emotional response to these restrictions. The total score is the sum of all 30 items (each yes scores 1 and each no scores 0), with 0 representing no influence of Behçet's disease on a participant's quality of life and 30 representing the most severe influence. A negative change from baseline indicates improvement.
Secondary	Change From baseline in Short Form-36 Health Status Questionnaire(SF-36)	Baseline to week 12	Short Form-36 Health Status Questionnaire(SF-36) is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Secondary	Corticosteroid-tapering effects.	Baseline to week 12	The dosage of glucocorticoids will be tapered tailored to the disease activity of each participant, and the change of dosage from baseline will be recorded.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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