Rebif® Pregnancy Registry

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00338741
First received: June 16, 2006
Last updated: August 2, 2013
Last verified: August 2011
  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 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


Condition Phase
Multiple Sclerosis
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rebif® Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Spontaneous Abortion [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    Number of participants having spontaneous abortion


Secondary Outcome Measures:
  • Fetal Death/Stillbirth [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
    Fetal death/stillbirth


Enrollment: 36
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Dan Mikol, MD EMD Serono
  More Information

Additional Information:
No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00338741     History of Changes
Other Study ID Numbers: 23888
Study First Received: June 16, 2006
Results First Received: April 30, 2010
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014