Trial · NCT05449548
Lenalidomide in the Treatment of Mucosal Behçet's Syndrome
NCT05449548, Not applicable, Recruiting, Peking Union Medical College Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide in the Treatment of Mucosal Behçet's Syndrome. Trials, record NCT05449548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05449548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide in the Treatment of Mucosal Behçet's Syndrome
- NCT number
- NCT05449548
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 42 participants, estimated
- Lead sponsor
- Peking Union Medical College Hospital
- Conditions
- Oral Ulcer
- Interventions
- Lenalidomide 10 mg
- First posted
- 2022-07-08
- Last updated
- 2026-06-22
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05449548
GET https://conductscience.org/api/trials/v1/NCT05449548/registered