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

NCT ID: NCT04163016

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-19
• Study Completion Date: 2023-05-23

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Crohn's Disease; Axial Spondyloarthritis; Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pharmacokinetics of certolizumab pegol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PK

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Up0085 104

Minneapolis, Minnesota, United States

Up0085 103

Durham, North Carolina, United States

Up0085 101

Oklahoma City, Oklahoma, United States

Up0085 500

Paris, , France

Up0085 202

Freiburg im Breisgau, , Germany

Up0085 201

Hamburg, , Germany

Up0085 900

Rotterdam, , Netherlands

Up0085 800

Barcelona, , Spain

Up0085 300

Bern, , Switzerland

Countries

United States; France; Germany; Netherlands; Spain; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UP0085

Identifier Type: -

Identifier Source: org_study_id