Rebif® Pregnancy Registry

Condition(s) targeted: Multiple Sclerosis

Phase: Phase 4

Status: Completed

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Bettina Stubinski, MD, Study Director, Affiliation: Sponsor

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

Official title: Rebif® Pregnancy Registry

Study design: Case Control, Prospective

Primary outcome: Rate of spontaneous abortion

Secondary outcome: Fetal anomalies, fetal death/stillbirth, complications of labor and delivery

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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 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

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

Full FDA approved prescribing information can be found here

Starting date: December 2002
Ending date: February 2008
Last updated: April 10, 2008