Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 17 month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).
연구 개요
상세 설명
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic Rochester
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-70 years old
- Diagnosis of Crohn's disease with fistula
- Test negative for Clostridium difficile within 3 weeks
- Signed informed consent, including permission to use protected health information.
Exclusion Criteria:
- History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
- Pregnant or nursing
- HIV, Hepatitis B or Hepatitis C infection
- Presence of obstructive symptoms, confirmed by endoscopy, within 6 months
- Likely to require surgery in the next 6 months
- Serious or active infections within 1 year
- Active infections that require antibiotic therapy
- Serious infections that require IV antibiotics or hospitalization within 8 weeks
- Started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-ASA), antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
- Had increased dose of corticosteroids within 2 weeks
- Received a live vaccine within 6 weeks
- Received any monoclonal antibodies or investigational agents within 3 months
- Received cyclosporine or tacrolimus (FK506) within 4 weeks
- Dose change or discontinuation of 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
- Significant organ dysfunction
- History of lymphoproliferative disorder
- History of tuberculosis, mycobacterial infection, or positive chest x-ray
- History of thrombophlebitis or pulmonary embolus
- History of immune deficiency or autoimmune disorders (other than Crohn's disease)
- History of seizure with subtherapeutic levels of anticonvulsive medication within one week
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
|---|
|
Clinical response, defined as external closure of at least 50% of perianal fistulas, without an accompanying increase in dose of concomitant medications, the addition of new medications, or Crohn's Disease-related surgery.
|
2차 결과 측정
결과 측정 |
|---|
|
Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .