Clinical trial NCT00472992: Pregnancy Exposure Registry for Tysabri®
Official title: TYSABRI® Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Prenatal Exposure
Multiple Sclerosis
Pregnancy
Keywords: Pregnancy
TYSABRI
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2007-05-14
Enrollment: 376
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with MS or CD who were exposed to Tysabri® in the US, Canada, and the Rest of World within 90 days prior to their last menstrual period.

Brief summary: The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.

Detailed description: This study was conducted in coordination with the TYSABRI® Global Observational Program in Safety (TYGRIS) observational study in the United States (US), Canada, and Rest of World (ROW).

The Coordinating Center (CC) monitored participants throughout their pregnancies and monitored the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks after the Estimated Date of Delivery (EDD) in the ROW.

Eligibility criteria: Key Inclusion Criteria:

Females who become pregnant while they are taking TYSABRI® as part of the TYGRIS program, during a clinical trial with TYSABRI® that is sponsored by Biogen-Idec, or in the post-marketing setting may enroll in this Registry, as follows:

1. Documentation that the patient was exposed to TYSABRI® within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
2. The outcome of the pregnancy must not be known at the time of enrollment. For pregnancies for which the outcomes are known at the time of enrollment, the information will be collected as retrospective reports and analyzed separately.
3. For US patients, verbal informed consent must be collected at the time of enrollment. The Coordinating Center (CC) obtains verbal informed consent (if verbal consent has not already been obtained by the physician). The CC then mails the patient a Release of Medical Information form to sign and return. If the patient is a minor, verbal consent must be obtained from the parent or legal guardian and verbal assent must be obtained from the patient.
4. For Canadian patients, a written informed consent must be collected by the TYGRIS investigator at the time of enrollment. A Release of Medical Information form will also be signed by the patient and returned to the CC.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies
timeFrame: Approximately 9 months
measure: Number of elective or therapeutic pregnancy terminations
timeFrame: Approximately 9 months
measure: Number of Live Births
timeFrame: 4 weeks after the estimated date of delivery
measure: Number of Live Births with Birth Defects
timeFrame: 8-12 weeks post-birth
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: United BioSource Corporation
state: West Virginia
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Friend S, Richman S, Bloomgren G, Cristiano LM, Wenten M. Evaluation of pregnancy outcomes from the Tysabri(R) (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. 2016 Aug 24;16(1):150. doi: 10.1186/s12883-016-0674-4.