Ivarmacitinib for Refractory Behcet's Syndrome
Efficacy and Safety of the Novel, Highly Selective JAK Inhibitor Ivarmacitinib in the Treatment of Behçet's Disease: A Multicenter Prospective Study
Behcet's syndrome (BS) is a multisystem autoimmune vasculitis. Current clinical treatment primarily includes glucocorticoids, immunosuppressants, and molecularly targeted drugs such as TNF-α and IL-6 inhibitors; however, some patients still respond poorly to existing treatment regimens. The JAK-STAT signaling pathway serves as a common downstream signaling pathway for various cytokines involved in the pathogenesis of Behcet's syndrome. Upon binding to their receptors, cytokines activate JAK kinases, which in turn phosphorylate STAT proteins to regulate the expression of inflammation-related genes. Therefore, blocking the JAK-STAT pathway can simultaneously inhibit the signal transduction of multiple pathogenic cytokines, thereby exerting anti-inflammatory effects. Consequently, Ivarmacitinib-a highly selective JAK1 inhibitor-holds promise for improving the prognosis and quality of life of patients with refractory Behçet's syndrome.
This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of Ivarmacitinib in Behçet's syndrome (BS) . Patients with refractory Behçet's syndrome were enrolled . Patients received Ivarmacitinib for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Tian Liu
- 전화번호: +8613661345637
- 이메일: Liutian03973@pku.edu.cn
연구 연락처 백업
- 이름: Yirui Lian
- 전화번호: +86 15037924173
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국
- Department of Rheumatology and Immunology, Peking University People's Hospital
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연락하다:
- Yirui Lian
- 전화번호: +86 15037924173
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연락하다:
- Tian Department of Rheumatology and Immunology, Peking University P
- 전화번호: • +86 136 6134 5637
- 이메일: Liutian03973@pku.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
① Meets the 1990 ISG diagnostic criteria for Behçet's syndrome [9];
Aged 18-70 years; ③ Has shown an inadequate response to treatment after at least 6 months of therapy with glucocorticoids, at least two immunosuppressants, and/or biologics (including TNF-α inhibitors and IL-6 inhibitors);
- Agrees to receive treatment with a new targeted therapy
Exclusion Criteria:
① Patients with one or more other autoimmune diseases;
Patients who have undergone major surgery within 4 weeks prior to enrollment, or who are scheduled to undergo elective surgery during the study; ③ Patients with a confirmed acute or chronic active infection (e.g., bacterial, viral [such as EBV, CMV, HIV, or active hepatitis virus]) within 4 weeks prior to enrollment; ④ Patients with a current or past history of any malignancy;
Female patients who are pregnant or within 6 months postpartum;
- Patients with severe liver failure (Child-Pugh Class C) or end-stage renal disease (dialysis-dependent).
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: Ivarmacitinib for the Treatment of Refractory Behçet's Disease
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The specific regimen was 4 mg of Ivarmacitinib administered daily for 24 weeks.
All patients will undergo 24 weeks of prospective follow-up.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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완전 관해 및 부분 관해를 달성한 환자
기간: 24주차
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1차 평가변수는 전체 코호트에서 24주차까지 완전관해와 부분관해를 달성한 환자의 비율(%)로 정의됐다.
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24주차
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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: week24
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Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
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week24
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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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
- PKU People's Hospital SHR0302
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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