- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00338741
Rebif® Pregnancy Registry
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Massachusetts
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Rockland, Massachusetts, 미국, 02370
- Local Medical Information Office
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Rebif®-Exposed Group
For prospective follow-up, women in the United States and Canada shall be eligible for enrollment in the Rebif® Pregnancy Registry as subjects if:
- They are pregnant.
- They received Rebif® for treatment of Multiple Sclerosis (MS) within one week before or at any time after conception.
- The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy.
- They have not used Copaxone® for treatment of MS within the previous three months and have not been exposed to Novantrone®, Imuran®, Cytoxan®, Tysabri® or methotrexate at any time.
Patients who have been exposed to an investigational product or procedure within the previous year may be enrolled at the discretion of the Medical Director. The enrolling physician should contact Serono's authorized agent, a company called Registrat, at 866-997-3243 to request a review of each patient's situation.
Interferon-beta -Not Exposed Comparison Group
Women with MS who live in the United States or Canada will be eligible for the comparison group if:
- They are pregnant.
- The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy.
- They have not received any interferon-beta within 90 days of conception.
- They have not used Copaxone® for treatment of MS within the previous three months and have not been exposed to Novantrone®, Imuran®, Cytoxan®, Tysabri® or methotrexate at any time.
Patients who have been exposed to an investigational product or procedure within the previous year may be enrolled at the discretion of the Medical Director. The enrolling physician should contact Serono's authorized agent, a company called Registrat, at 866-997-3243 to request a review of each patient's situation.
Exclusion Criteria:
- Not Applicable
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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1
Rebif exposed pregnancies
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2
Non-Rebif exposed pregnancies
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Spontaneous Abortion
기간: Up to 9 months
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Number of participants having spontaneous abortion
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Up to 9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fetal Death/Stillbirth
기간: Up to 10 months
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Fetal death/stillbirth
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Up to 10 months
|
공동 작업자 및 조사자
간행물 및 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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 23888
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. .
다발성 경화증에 대한 임상 시험
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스