Rebif® Pregnancy Registry

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Rockland, Massachusetts, United States, 02370
      • Local Medical Information Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant MS patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Rebif exposed pregnancies
2; Non-Rebif exposed pregnancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous Abortion	Number of participants having spontaneous abortion	Up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Death/Stillbirth	Fetal death/stillbirth	Up to 10 months

Collaborators and Investigators

• Sponsor: EMD Serono
• Collaborators: Pfizer
• Investigators: Study Director: Dan Mikol, MD, EMD Serono

Publications and helpful links

Helpful Links

• Full FDA approved prescribing information can be found here

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 16, 2006
• First Submitted That Met QC Criteria: June 16, 2006
• First Posted (Estimate): June 20, 2006

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 23888