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Sponsors and Collaborators: |
EMD Serono Pfizer |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00338741 |
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 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
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Rebif® Pregnancy Registry |
Estimated Enrollment: | 300 |
Study Start Date: | December 2002 |
Study Completion Date: | February 2008 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Rebif exposed pregnancies
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2
Non-Rebif exposed pregnancies
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pregnant MS patients
Inclusion Criteria:
For prospective follow-up, women in the United States and Canada shall be eligible for enrollment in the Rebif® Pregnancy Registry as subjects if:
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:
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:
United States, Massachusetts | |
Local Medical Information Office | |
Rockland, Massachusetts, United States, 02370 |
Study Director: | Bettina Stubinski, MD | Sponsor GmbH |
Responsible Party: | EMD Serono, Inc ( Bettina Stubinski, Senior Medical Director ) |
Study ID Numbers: | 23888 |
Study First Received: | June 16, 2006 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00338741 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferon beta 1a |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |