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Completed

NCT Number: NCT04163016

A 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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Plaque Psoriasis Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Up0085 500, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacokinetics of certolizumab pegol

Drug

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

Primary outcomes

  1. Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum

    Time frame: Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)

    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.

Secondary outcomes

  1. Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period

    Time frame: From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)

    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.

  2. Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)

    Time frame: From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)

    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.

  3. Number of Participants With Pregnancy Outcome

    Time frame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)

    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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Acronym: CHERISH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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