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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis, Plaque Psoriasis

Intervention / Treatment
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* Drug: Pharmacokinetics of certolizumab pegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetics Sampling<br>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<br>* 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.<br>* Other names: PK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks) | 
| 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. | From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks) | 
| 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. | From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cimzia, Certolizumab Pegol, Pregnant Women, Crohn's Disease (CD), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Plaque Psoriasis (PSO), Axial Spondyloarthritis (AxSpA), Pharmacokinetics, CZP