Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

NCT02559713 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Vedolizumab-4001U1111-1171-5296
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Conditions

Colitis, Ulcerative; Crohn's Disease

Keywords

Lactation; Lactating Women; Vedolizumab; Colitis Ulcerative; Crohn's Disease; Crohn's

Outcome Measures

Primary Outcomes (7)

• Concentration of Vedolizumab in Breast Milk at Predose on Day 1

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by enzyme-linked immunosorbent assay (ELISA). Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

  Day 1 (60 minutes prior to the start of infusion)

• Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

  Day 1 (approximately 60 minutes after the end of infusion)

• Concentration of Vedolizumab in Breast Milk on Day 4

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

  Day 4

• Concentration of Vedolizumab in Breast Milk on Day 8

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

  Day 8

• Concentration of Vedolizumab in Breast Milk on Day 15

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

  Day 15

• Concentration of Vedolizumab in Breast Milk on Day 29

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

  Day 29

• Concentration of Vedolizumab in Breast Milk on Day 57

  Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk in participants with analysis of vedolizumab concentration from the pooled milk sample was done by ELISA.

  Day 57

Study Arms (1)

Vedolizumab 300 milligram (mg)

EXPERIMENTAL

Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

Vedolizumab IV infusion

Also known as: Entyvio, MLN0002

Vedolizumab 300 milligram (mg)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Lactating women with a diagnosis of active ulcerative colitis (UC) or Crohn's disease (CD) being treated with vedolizumab were enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is capable of understanding and complying with protocol requirements.
• Signs and dates as written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Is female and at least 18 years of age at the time of informed consent.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study.
• Is on established vedolizumab maintenance therapy and received at least 1 dose of 300 mg of vedolizumab IV postpartum or has completed vedolizumab induction therapy (300 mg of vedolizumab IV at Week 0, Week 2, and Week 6), which has been commenced by the participant's treating physician for the treatment of active UC or CD prior to enrolling in this study.
• Has delivered a single, normal term infant (at least 37 weeks' gestation) that is, a mother-infant pair is required.
• Is at least 5 weeks postpartum by Day 1.
• Lactation is well established, and the mother is exclusively breast feeding her infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.
• Participant has independently decided to be treated with vedolizumab or to breastfeed prior to providing consent to participate in this study.
• Plans to continue breastfeeding at least throughout the duration of this study.
• Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period.

You may not qualify if:

• Has received any investigational compound or approved biologic or biosimilar agent, except for vedolizumab within 60 days prior to enrollment in the study.
• Within 30 days prior to enrollment, the participant has received any of the following for the treatment of underlying disease:
• Nonbiologic therapies \[example (eg), cyclosporine\], other than those listed in the protocol.
• An approved nonbiologic therapy in an investigational protocol.
• Has received any live vaccinations within 30 days prior to vedolizumab administration.
• Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures or allergic skin rash that, in the opinion of the investigator, would confound the study results or compromise participant safety. Additionally, if there is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a similar drug that might interfere with the conduct of the study.
• Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period.
• Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Participants with remote history of malignancy (eg, greater than (\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
• Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
• Has a positive progressive multifocal leukoencephalopathy subjective symptom checklist at screening.
• Has a current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
• Has active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
• Is unable to participate in all the study visits or comply with study procedures.

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Feinberg School of Medicine Northwestern University

Chicago, Illinois, 60637, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-1150, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Sun W, Fennimore B, Beaulieu DB, Arsenescu R, Stein AC, Chen J, Lin T, McKnight S, Kadali H, Rosario M, Lirio RA. Vedolizumab Concentrations in Breast Milk: Results from a Prospective, Postmarketing, Milk-Only Lactation Study in Nursing Mothers with Inflammatory Bowel Disease. Clin Pharmacokinet. 2021 Jun;60(6):811-818. doi: 10.1007/s40262-021-00985-4. Epub 2021 Feb 5.

  PMID: 33544318 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Breast Feeding

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Feeding Behavior; Behavior

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: November 29, 2017
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: January 8, 2021
• Results First Posted: March 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (7)