A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) (CHERISH)

June 14, 2023 updated by: UCB Biopharma SRL

A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.

Study Overview

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France
        • Up0085 500
      • Freiburg, Germany
        • Up0085 202
      • Hamburg, Germany
        • Up0085 201
      • Rotterdam, Netherlands
        • Up0085 900
      • Barcelona, Spain
        • Up0085 800
      • Bern, Switzerland
        • Up0085 300
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Up0085 104
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Up0085 103
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Up0085 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is pregnant and ≤10 weeks gestation at the time of enrollment
  • Participant must have been on stable, maintenance dose certolizumab pegol (CZP) treatment for at least 12 weeks independent of and prior to being enrolled in this study, for an approved indication in accordance with her treating physician
  • Participant expects to continue CZP therapy throughout pregnancy and for at least 12 weeks postpartum
  • Participant has a negative interferon gamma release assay (IGRA) or tuberculin skin test (TST) within the prior 6 months, and there has been no change in the study participant's clinical status, or social, family, or travel history. Participants with documented Bacillus Calmette-Guérin (BCG) vaccine and at low risk for tuberculosis (TB) may enroll without having a TB test performed

Exclusion Criteria:

  • Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
  • Participant is not permitted to enroll into the study if she meets any of the following TB exclusion criteria:

    1. Known active TB disease
    2. History of active TB involving any organ system
    3. Latent TB infection
    4. High risk of acquiring TB infection
    5. Current nontuberculous mycobacterial (NTM) infection or history of NTM infection (unless proven to be fully recovered)
  • Study participant is taking a prohibited medication or has taken a prohibited medication
  • Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
  • Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
  • Study participant had a positive or indeterminate interferon gamma release assay (IGRA) or tuberculin skin test (TST) at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacokinetics Sampling

This study will include pregnant women who have decided to continue treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants will be responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label.

From all study participants blood samples will be drawn for pharmacokinetics during the study.

The collection of blood samples for pharmacokinetics (PK) is considered interventional. Blood samples will be drawn at enrollment, predose every 4 weeks (Q4W), postdose every 8 weeks (Q8W) and postpartum predose and postdose.

Study participants will be responsible for obtaining and administering commercially available approved dosing regimens of certolizumab pegol (CZP) as prescribed by each study participant's own physician.

Other Names:
  • PK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predose and postdose plasma certolizumab pegol (CZP) concentrations in women during pregnancy, relative to postpartum
Time Frame: From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks)
Mean differences with 95% confidence interval (CI) of CZP plasma concentrations between samples taken during pregnancy and baseline (postpartum samples) will be estimated within a mixed effect model using contrasts.
From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma levels of anti-certolizumab pegol (CZP) antibodies throughout the study period
Time Frame: From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks)
Antibodies to CZP will be evaluated in plasma samples collected from all participants throughout the study.
From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks)
Adverse events from time of informed consent through Safety Follow-up (SFU)
Time Frame: From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks)
Pregnancy outcome
Time Frame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)
Pregnancy outcomes will be collected via a written notification by the investigator and recorded in the Pregnancy Outcome Form. Pregnancies will be determined to end in delivery-live birth, delivery-still birth, Spontaneous abortion, or Therapeutic abortion.
From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2020

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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