- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01282528
Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis (ULTRA)
연구 개요
상세 설명
This is an open-lable, single arm study of the ultrasonographic monitoring of response to infliximab in patients with rheumatoid arthritis. Approximately 120 subjects will be enrolled. Subjects will receive infliximab 3mg/kg intravenous infusion at 0, 2, 6 week, and then repeated every 8 weeks until 24 weeks.
The efficacy assessment is observed by ACR response, HAQ, DAS28, sharp scores and US assessment at 0,2,6,14, 22, and 24weeks and ultrosonographic and radiographic assessments are conducted at 0, 6,and 24weeks.
Subjects will be followed for AEs and SAEs up to 8 weeks following the last study treatment administration (see Section 6).
The end of study is defined as the time the last subject completes the 24 weeks visit.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Xiaomei Leng, MD
- 전화번호: 86-13681057089
- 이메일: lengxm@gmail.com
연구 연락처 백업
- 이름: Yan Zhao, MD
- 전화번호: 86-13910188862
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100000
- 모병
- Perking Union Medical College Hospital
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연락하다:
- Xiaomei Leng, MD
- 전화번호: +86-13681057089
- 이메일: lengxm@gmail.com
-
수석 연구원:
- Xiaomei Leng, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age 18-65 years, male or female and who are capable of providing informed consent, which must be obtained prior to any study-related procedures.
- Those who have a definitive diagnosis of RA based on the criteria of American College of Rheumatology in 1987 and have moderate to severe disease (DAS28 more than 3.2).
- Patients using oral corticosteroids, must have been on a stable dose of prednisone 10mg/day or its equivalent for at least 4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for at least 4 weeks prior to screening.
- Patients using DMARDs, must have been on a stable dose for at least 12 weeks prior to screening. If currently not using DMARDs the patient must have not received DMARDs for at least 12 weeks prior to screening.
- If using NSAIDs or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent.
Exclusion Criteria:
- Patient who has a known hypersensitivity to human immunoglobulin proteins or other components of infliximab.
- Patient who suffers from systemic inflammatory disease whose signs and symptoms are expected to affect the evaluation of the study drug.
- Patient who has a history of receiving infliximab or any other biologics.
- Patient who has stage IV RA.
- Patient who has had or is on live viral or bacterial vaccinations within 4 weeks to study entry.
- Patient who ever suffered from chronic or recurrent infection, including but not limited to: chronic kidney infection, chronic thoracic cavity infection (eg. bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drain or dermal infected wound.
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 |
기간 |
---|---|
The primary objective of this study is to evaluate the efficacy of treatment with infliximab on synovitis in RA patients using ultrasonography at 24 weeks.
기간: 24 weeks
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24 weeks
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2차 결과 측정
결과 측정 |
기간 |
---|---|
estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography
기간: 6, 24 weeks
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6, 24 weeks
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investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores
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3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Yan Zhao, MD, Perking Union Medical College Hospital
- 수석 연구원: Xiaomei Leng, MD, Perking Union Medical College Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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. .
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