适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Spontaneous Abortion
研究概览
简要总结
The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed pregnancies. This rate will be compared with the rate of spontaneous abortions in patients with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy Exposure Registries
详细描述
This study is a post-approval commitment to follow Rebif®-exposed pregnancies and compare them to non-Rebif® exposed pregnancies to evaluate rate of spontaneous abortion, fetal abnormality or pregnancy related health outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not Applicable
结局指标
主要结局
Spontaneous Abortion
时间窗: Up to 9 months
Number of participants having spontaneous abortion
次要结局
- Fetal Death/Stillbirth(Up to 10 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW)PsoriasisPregnancyNCT00097240Genentech, Inc.18
招募中
不适用
Prospective Recurrent Pregnancy Loss RegistryRecurrent Pregnancy LossNCT05989178University of British Columbia3,000
已完成
不适用
Boostrix® Pregnancy RegistryPertussisNCT02096276GlaxoSmithKline1,517
终止
不适用
Pregistry International Pregnancy Exposure Registry (PIPER)Pregnancy RelatedNCT05352256Pregistry300
已完成
不适用
Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)Prenatal Exposure Delayed EffectsPregnancyMultiple SclerosisNCT00168714Biogen329