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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

June 16, 2006
August 2, 2013
December 2002
October 2007   (final data collection date for primary outcome measure)
Spontaneous Abortion [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
Number of participants having spontaneous abortion
Not Provided
Complete list of historical versions of study NCT00338741 on ClinicalTrials.gov Archive Site
Fetal Death/Stillbirth [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
Fetal death/stillbirth
Not Provided
Not Provided
Not Provided
 
Rebif® Pregnancy Registry
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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pregnant MS patients

Multiple Sclerosis
Not Provided
  • 1
    Rebif exposed pregnancies
  • 2
    Non-Rebif exposed pregnancies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2008
October 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338741
23888
Not Provided
EMD Serono
EMD Serono
Pfizer
Study Director: Dan Mikol, MD EMD Serono
EMD Serono
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP