Ustekinumab for Intestinal Behçet's Syndrome With Myelodysplastic Syndrome
Efficacy and Safety of Ustekinumab for Intestinal Behçet's Syndrome Complicated by Myelodysplastic Syndrome
연구 개요
상세 설명
This is a multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of ustekinumab in patients with intestinal Behçet's syndrome complicated by myelodysplastic syndrome (MDS). A total of 8 patients with intestinal Behçet's syndrome and concomitant MDS will be enrolled. Prior to enrollment, all patients will discontinue any previous biologic agents. Ustekinumab will be administered subcutaneously at a dose of 90 mg at weeks 0, 4, and 8, followed by a maintenance dose of 90 mg every 12 weeks (every 3 months). All patients will be followed for a total of 24 months.
Clinical manifestations, inflammatory biomarkers, and endoscopic findings will be documented throughout the study period. Concomitant medications will be recorded, and adverse events will be systematically monitored to evaluate the efficacy and safety of the treatment.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Beijing, 중국, 100044
- Department of Rheumatology and Immunology, Peking University People's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Meet the 2014 International Criteria for Behçet's Disease (ICBD) for the diagnosis of Behçet's syndrome; Have a confirmed diagnosis of myelodysplastic syndrome (MDS) by bone marrow aspiration and/or biopsy; Have confirmed intestinal ulcers on colonoscopy; Aged between 18 and 70 years; Have active disease at enrollment, defined as a Behçet's Disease Current Activity Form (BDCAF) score ≥ 1; Provide signed informed consent.
Exclusion Criteria:
Presence of one or more other autoimmune diseases; Involvement of other vital organs (e.g., cardiovascular, neurological) requiring treatment with other biologic agents or high-dose corticosteroids; Receipt of surgical treatment; Severe trilineage cytopenia attributed to myelodysplastic syndrome; Presence of acute or chronic active infection (e.g., bacterial, or viral infections such as EBV, CMV, HIV, or active hepatitis virus) within 4 weeks prior to enrollment; Current or prior history of any malignancy; Pregnancy or within 6 months postpartum; Presence of severe liver failure (Child-Pugh Class C) or end-stage renal disease requiring dialysis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Treated with ustekinumab
Eight patients with intestinal Behçet's syndrome complicated by myelodysplastic syndrome were treated with ustekinumab.
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Ustekinumab will be administered subcutaneously at a dose of 90 mg at weeks 0, 4, and 8, followed by a maintenance dose of 90 mg every 12 weeks (every 3 months).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patients achieving complete remission, marked improvement, and improvement
기간: Week 24
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The primary endpoint was defined as the proportion of patients achieving each response category at week 24.
The response categories included complete remission, marked improvement, and improvement, as defined by the Global Gastrointestinal Symptoms criteria, with the proportion of patients achieving each category expressed as a percentage (%).
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Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes of Behcet's Disease Current Activity Form (BDCAF) score of patients
기간: Week 24
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Clinical manifestations are recorded at enrollment and at week 24, and changes in the BDCAF score from baseline to week 24 are evaluated.
The score of BDCAF ranges from 0 to 12, with higher scores indicating greater severity.
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Week 24
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Changes of Disease Activity Index for Intestinal Behcet's Disease (DAIBD) of patients
기간: Week 24
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Intestinal-related clinical manifestations are documented at enrollment and at week 24.
Changes in the DAIBD score from baseline to week 24 are evaluated.
The score of DAIBD ranges from 0 to 295, with higher scores indicating greater severity.
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Week 24
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Changes of C-reactive protein
기간: Week 24
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Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.
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Week 24
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Changes of erythrocyte sedimentation rate
기간: Week 24
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Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
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Week 24
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Changes of dosage of glucocorticoids from baseline
기간: Week 24
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The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.
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Week 24
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스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Peking University PH
- PAYJ-023 (기타 보조금/기금 번호: Bethune-Puai Medical Research Fund)
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