Rebif® Pregnancy Registry - Full Text View

Sponsors and Collaborators:	EMD Serono Pfizer
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00338741

Purpose

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

Condition	Phase
Multiple Sclerosis	Phase IV

MedlinePlus related topics: Multiple Sclerosis Pregnancy Loss

Drug Information available for: Interferon beta 1a

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Rebif® Pregnancy Registry

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Rate of spontaneous abortion [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fetal anomalies, fetal death/stillbirth, complications of labor and delivery [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
1 Rebif exposed pregnancies
2 Non-Rebif exposed pregnancies

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pregnant MS patients

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338741

Locations

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

Sponsors and Collaborators

EMD Serono

Pfizer

Investigators

Study Director:

Bettina Stubinski, MD

Sponsor GmbH

More Information

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferon beta 1a

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009