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Trial record 1 of 1 for:    NCT00338741
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Rebif® Pregnancy Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00338741
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : June 2, 2010
Last Update Posted : August 5, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
EMD Serono

Tracking Information
First Submitted Date June 16, 2006
First Posted Date June 20, 2006
Results First Submitted Date April 30, 2010
Results First Posted Date June 2, 2010
Last Update Posted Date August 5, 2013
Study Start Date December 2002
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2010)
Spontaneous Abortion [ Time Frame: Up to 9 months ]
Number of participants having spontaneous abortion
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2010)
Fetal Death/Stillbirth [ Time Frame: Up to 10 months ]
Fetal death/stillbirth
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rebif® Pregnancy Registry
Official Title Rebif® Pregnancy Registry
Brief Summary 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
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant MS patients
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Rebif exposed pregnancies
  • 2
    Non-Rebif exposed pregnancies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2010)
36
Original Enrollment
 (submitted: June 16, 2006)
300
Actual Study Completion Date February 2008
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00338741
Other Study ID Numbers 23888
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party EMD Serono
Study Sponsor EMD Serono
Collaborators Pfizer
Investigators
Study Director: Dan Mikol, MD EMD Serono
PRS Account EMD Serono
Verification Date August 2011