- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01101295
The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia. (ITP-RITUX)
The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.
연구 개요
상태
상세 설명
Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.
Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Bertrand GODEAU, MD
- 전화번호: 0033149812900
- 이메일: bertrand.godeau@hmn.aphp.fr
연구 연락처 백업
- 이름: Mehdi KHELLAF, MD
- 전화번호: 0033149812076
- 이메일: mehdi.khellaf@hmn.aphp.fr
연구 장소
-
-
Val de Marne
-
Creteil, Val de Marne, 프랑스, 94010
- 모병
- Henri Mondor University Hospital
-
연락하다:
- Mehdi KHELLAF, MD
- 전화번호: 0033149812076
- 이메일: mehdi.khellaf@hmn.aphp.fr
-
부수사관:
- Mehdi KHELLAF, MD
-
Creteil, Val de Marne, 프랑스, 94010
- 모병
- National Reference Center for the Study of Auto Immune Cytopenia
-
연락하다:
- Mehdi KHELLAF, MD
- 전화번호: 0033149812076
- 이메일: mehdi.khellaf@hmn.aphp.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- ITP diagnosis according to the American Society of Hematology society
- Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)
Exclusion Criteria:
- Previous treatment by rituximab
- Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)
- Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Occurrence of a serious adverse events (clinical or biological events)
기간: 5 years
|
reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...
|
5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Impact of rituximab on the natural history of ITP
기간: 5 years
|
Number of patients in complete response (platelet count>100G/L), in partial response (platelet count>50G/L and at least doubling the baseline platelet count)or in failure. Rate of diminution for the concomittant therapies for ITP. Use of emergencies treatment for ITP. |
5 years
|
Modality of the administration of rituximab
기간: 5 years
|
number of perfusions, dosage, retreatment.
|
5 years
|
Characteristics of the patients receiving Rituximab
기간: 5 years
|
age, sex, duration of ITP, previous used treatment
|
5 years
|
Evaluation of the Platelet count evolution
기간: 5 years
|
Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.
|
5 years
|
Rate of splenectomy in the cohort
기간: 5 years
|
5 years
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Bertrand GODEAU, MD, National Reference Center for Study of Cytopenia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- GECAI
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