Study Results
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View full resultsBasic Information
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COMPLETED
36 participants
OBSERVATIONAL
2002-12-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
Rebif exposed pregnancies
No interventions assigned to this group
2
Non-Rebif exposed pregnancies
No interventions assigned to this group
Eligibility Criteria
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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:
* 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
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Mikol, MD
Role: STUDY_DIRECTOR
EMD Serono
Locations
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Local Medical Information Office
Rockland, Massachusetts, United States
Countries
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Related Links
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Full FDA approved prescribing information can be found here
Other Identifiers
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23888
Identifier Type: -
Identifier Source: org_study_id
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