Vedolizumab in Lactating Mothers

WIRB 20151219
#15863338.1

Takeda Pharmaceuticals, USA is recruiting patients for an important research study.  This is a “Multicenter and Open Enrollment model, Postmarketing Study to Evaluate the Concentration of vedolizumab in the Breast Milk of Mothers receiving Treatment with Vedolizumab”.

Vedolizumab, also known as Entyvio®, is a prescription medication for the treatment of adults with moderate to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Its use in this study is investigational.

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active UC or CD who are receiving vedolizumab for treatment.

It is unknown whether vedolizumab is present in human breast milk, so Takeda is conducting a research study to find out more. Vedolizumab should be used with caution while breastfeeding and should be a decision made at the advice of your doctor.

Takeda would like to recruit mothers for this study, who in conjunction with their doctor, have already made the decision to use vedolizumab prior to taking part in this research study to determine just how much of this product enters the mother’s milk.


Inclusion Criteria:

To be eligible to participate for the study, all of the following criteria must be met:

  1. You must be at least 18 years of age at the time of informed consent.
     
  2. You must agree to use non estrogen containing oral birth control preparations or other contraception if you are of childbearing potential and sexually active with a non-sterilized male.
     
  3. You are on an established vedolizumab maintenance therapy, as prescribed by your doctor and received at least 1 dose of 300 mg of vedolizumab IV postpartum or have completed vedolizumab induction therapy (300 mg of vedolizumab IV at Week 0, Week 2, and Week 6), which has been commenced by your doctor for the treatment of active UC or CD prior to enrolling in this study.
     
  4. You must have given birth to a single infant at least 37 weeks into your pregnancy.
     
  5. You are at least 5 weeks postpartum at the start of the Sampling period.
     
  6. You have established lactation and are exclusively breastfeeding your infant or not providing more than one [1] supplemental bottle of formula per day at the time you enroll in the study.
     
  7. Your therapy with vedolizumab, and your decision to breastfeed, must be chosen by you and your doctor without considering whether you will take part in this study.
     
  8. You plan to continue breastfeeding throughout the duration of the study which is up to 3 months.
     
  9. You agree to use only the emollient or nipple cream recommended by the study doctor during the Sampling period.

 

Exclusion Criteria:

You will not be able to participate in the study if any of the following criteria are met:

  1. You have taken part in another study for a drug within the 60 days prior to Screening.
     
  2. You have any condition that your study doctor thinks would make it difficult or unsafe for you to be in the study.
     
  3. You have abused alcohol or drugs in the last year.
     
  4. You are taking a medication that is not allowed (this will be reviewed with you by your study doctor). If you start taking a medication that is not allowed during the study, you will be withdrawn from the study.
     
  5. You have had recent surgery requiring general anesthesia or are planning to undergo major surgery during the study period, which is up to 3 months.
     
  6. You have breast implants or have had surgery to change the size of your breasts (augmentation or reduction).
     
  7. You have a positive pregnancy test.

 

The study consists of 7 Separate Visits:

3 Separate Visits for complete physical exams, health history questions and pregnancy testing completed at a location of your choice:

§    Your doctor’s office

§    The clinic where you are receiving your care

§    One of the research sites

4 Additional Visits for breastmilk sample collection:

§    Your doctor’s office

§    The clinic where you are receiving your care

§    One of the research sites

§    At your home

 

For home visits a home health nurse will come to your home to assist in breast milk sample collections and to obtain the samples for the study.

Vedolizumab is not provided as part of this study and you already have to be taking it before entrance into the study. You and your health care provider will be compensated for time and help in this study.

PLEASE REMEMBER, the Infant Risk Center is all about helping other mothers with questions about drugs.  I have many drug trials going on at any one time, all with the intention of helping mothers that may call in the future.  Your help in this study will be appreciated by many moms in the future.

Dr. Tom Hale

The Infant Risk Center
www.infantrisk.com

 

Click here to join this Study:  www.ucandbreastfeeding.com