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

Phase 1

Completed

• Conditions: Psoriatic Arthritis; Axial Spondyloarthritis; Plaque Psoriasis; Rheumatoid Arthritis; Crohn's Disease
• Interventions: Drug: Pharmacokinetics of certolizumab pegol

• Registration Number: NCT04163016
• Lead Sponsor: UCB Biopharma SRL

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Study Start: 2020-06-19
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetics Sampling	Pharmacokinetics of certolizumab pegol	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.

Primary Outcome Measures

Name	Time	Method
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum	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 Outcome Measures

Name	Time	Method
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period	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.
Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)	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.
Number of Participants With Pregnancy Outcome	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.

Trial Locations

Locations (9)

Up0085 300; 🇨🇭 Bern, Switzerland

Up0085 500; 🇫🇷 Paris, France

Up0085 104; 🇺🇸 Minneapolis, Minnesota, United States

Up0085 103; 🇺🇸 Durham, North Carolina, United States

Up0085 101; 🇺🇸 Oklahoma City, Oklahoma, United States

Up0085 900; 🇳🇱 Rotterdam, Netherlands

Up0085 202; 🇩🇪 Freiburg, Germany

Up0085 201; 🇩🇪 Hamburg, Germany

Up0085 800; 🇪🇸 Barcelona, Spain