A Multicenter Randomized Controlled Trial of Corticotropin for the Treatment of Behçet's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the number of active oral aphthous ulcers from baseline to Week 12
研究概览
简要总结
Adrenocorticotropic hormone (ACTH) is a polypeptide hormone secreted by the anterior pituitary gland. It can stimulate adrenal cortical hyperplasia and the secretion of glucocorticoids, thereby exerting anti-inflammatory, immunosuppressive and anti-allergic effects. Its mechanism of action differs from direct administration of glucocorticoids; it may exert milder modulatory effects on the immune system and reduce adverse reactions induced by long-term glucocorticoid use. Clinically, ACTH has been applied in the treatment of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. Nevertheless, sufficient randomized controlled trials are lacking to verify its efficacy and safety for mucosal involvement in Behçet's syndrome. Accordingly, this clinical trial aims to evaluate the efficacy and safety of ACTH in treating mucosal lesions associated with Behçet's syndrome, so as to provide evidence for its rational clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years, no restriction on gender. Meet the 1990 International Study Group (ISG) classification criteria for Behçet's disease, with a confirmed diagnosis for at least 3 months prior to screening enrollment.
- •Present with active oral ulcers, defined as no less than 2 definite active oral ulcers at screening.
- •Voluntarily participate in this study, sign the written informed consent form, and be capable of completing all scheduled follow-up visits and examinations throughout the trial.
排除标准
- 未提供
研究组 & 干预措施
ACTH Treatment Group
Participants receive repository corticotropin injection (ACTH) 25 IU via intramuscular injection twice weekly for 12 consecutive weeks. No additional glucocorticoids, immunosuppressants or other drugs interfering with study efficacy assessment are permitted during the treatment period. After completing the 12-week intervention, subjects enter a 12-week off-treatment follow-up phase for efficacy and safety observation.
干预措施: Repository Corticotropin Injection (ACTH) (Drug)
Placebo Control Group
Participants will receive physiologically inactive placebo injection, with identical appearance, injection route, administration frequency and treatment duration as the ACTH intervention arm. Injections are given intramuscularly twice weekly for 12 consecutive weeks, with identical restrictions on prohibited concomitant medications. Subjects will also complete a 12-week off-treatment observational follow-up after the intervention period ends.
干预措施: Study-matched inactive placebo injection, also called control injection (Drug)
结局指标
主要结局
Change in the number of active oral aphthous ulcers from baseline to Week 12
时间窗: Baseline (Week 0) and Week 12
The primary efficacy endpoint is the change in count of active painful oral aphthous ulcers in patients with Behçet's syndrome, comparing the difference of ulcer quantity between baseline screening visit and the end of 12-week intervention period, to evaluate the therapeutic effect of ACTH on mucosal lesions.
Change in Behçet's disease mucosal lesion score from baseline at week 12
时间窗: Baseline, Week 12
次要结局
- Change in disease activity score(From baseline up to Week 24)
- Change in number of active genital ulcers from baseline to Week 12(Baseline (Week 0), Week 12)
- Change in visual analog scale (VAS) pain score of oral ulcers from baseline to Week 12(Baseline (Week 0), Week 4, Week 8, Week 12)
- Change in Behçet's Disease Current Activity Form (BDCAF) and Behçet Syndrome Activity Score (BSAS) from baseline to Week 12(Baseline (Week 0), Week 12)
- Change in 36-Item Short Form Health Survey (SF-36) total score from baseline to Week 12(Baseline (Week 0), Week 12)
研究者
Liu Tian
Associate Professor
Peking University People's Hospital