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

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

• Status: Completed
• Conditions: Rheumatoid Arthritis; Plaque Psoriasis; Crohn's Disease; Psoriatic Arthritis; Axial Spondyloarthritis
• Intervention / Treatment: Drug: Pharmacokinetics of certolizumab pegol

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Up0085 500
• Germany
  • Freiburg, Germany
    • Up0085 202
  • Hamburg, Germany
    • Up0085 201
• Netherlands
  • Rotterdam, Netherlands
    • Up0085 900
• Spain
  • Barcelona, Spain
    • Up0085 800
• Switzerland
  • Bern, Switzerland
    • Up0085 300
• United States
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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.

Drug: Pharmacokinetics of certolizumab pegol; 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	Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.	Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period	Antibodies to CZP were evaluated in plasma samples collected from all participants throughout the study. Anti-CZP antibodies (ADAb) were measured using a three-tiered assay approach: screening, confirmatory and titration assay. Samples that were confirmed as positive in the screening and confirmatory assay were evaluated in a titration assay to quantify the ADAb level and were reported as titer (reciprocal dilution factor including minimum required dilution [MRD]). Sample values that were 'positive screen' and 'positive immunodepletion' were defined as ADAb positive. Once determined positive, a study participant's highest titer was used to categorize ("titer classification") the study participant as follows: Positive less than or equal to (=)32, Positive greater than (>)32 - =128, Positive >128 - =512, Positive >512 - =1024, Positive >1024 - =4096, and Positive >4096.	From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)	An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP.	From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
Number of Participants With Pregnancy Outcome	Pregnancy outcomes were collected via a written notification by the investigator and recorded in the Pregnancy Outcome Form. Pregnancies were determined to end in delivery-live birth, delivery-still birth, spontaneous abortion, therapeutic abortion, or missing data.	From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

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 (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Cimzia; Certolizumab Pegol; Rheumatoid Arthritis (RA); Pregnant Women; Crohn's Disease (CD); CZP; Psoriatic Arthritis (PsA); Plaque Psoriasis (PSO); Axial Spondyloarthritis (AxSpA)
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Gastroenteritis; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Arthritis; Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Certolizumab Pegol
• Other Study ID Numbers: UP0085; 2019-003410-13 (EudraCT Number)

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