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

Primary Purpose

Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pharmacokinetics of certolizumab pegol
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Cimzia, Certolizumab Pegol, Pregnant Women, Crohn's Disease (CD), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Plaque Psoriasis (PSO), Axial Spondyloarthritis (AxSpA), Pharmacokinetics, CZP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Up0085 104
  • Up0085 103
  • Up0085 101
  • Up0085 500
  • Up0085 202
  • Up0085 201
  • Up0085 900
  • Up0085 800
  • Up0085 300

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacokinetics Sampling

Arm Description

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.

Outcomes

Primary Outcome Measures

Predose and postdose plasma certolizumab pegol (CZP) concentrations in women during pregnancy, relative to postpartum
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.

Secondary Outcome Measures

Plasma levels of anti-certolizumab pegol (CZP) antibodies throughout the study period
Antibodies to CZP will be evaluated in plasma samples collected from all participants throughout the study.
Adverse events from time of informed consent through Safety Follow-up (SFU)
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.
Pregnancy outcome
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.

Full Information

First Posted
October 24, 2019
Last Updated
June 14, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04163016
Brief Title
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Acronym
CHERISH
Official Title
A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis, Plaque Psoriasis
Keywords
Cimzia, Certolizumab Pegol, Pregnant Women, Crohn's Disease (CD), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Plaque Psoriasis (PSO), Axial Spondyloarthritis (AxSpA), Pharmacokinetics, CZP

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacokinetics Sampling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pharmacokinetics of certolizumab pegol
Other Intervention Name(s)
PK
Intervention Description
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.
Primary Outcome Measure Information:
Title
Predose and postdose plasma certolizumab pegol (CZP) concentrations in women during pregnancy, relative to postpartum
Description
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.
Time Frame
From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks)
Secondary Outcome Measure Information:
Title
Plasma levels of anti-certolizumab pegol (CZP) antibodies throughout the study period
Description
Antibodies to CZP will be evaluated in plasma samples collected from all participants throughout the study.
Time Frame
From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks)
Title
Adverse events from time of informed consent through Safety Follow-up (SFU)
Description
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.
Time Frame
From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks)
Title
Pregnancy outcome
Description
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.
Time Frame
From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Known active TB disease History of active TB involving any organ system Latent TB infection High risk of acquiring TB infection 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Up0085 104
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Up0085 103
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Up0085 101
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Up0085 500
City
Paris
Country
France
Facility Name
Up0085 202
City
Freiburg
Country
Germany
Facility Name
Up0085 201
City
Hamburg
Country
Germany
Facility Name
Up0085 900
City
Rotterdam
Country
Netherlands
Facility Name
Up0085 800
City
Barcelona
Country
Spain
Facility Name
Up0085 300
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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