A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) (CHERISH)
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|ClinicalTrials.gov Identifier: NCT04163016|
Recruitment Status : Suspended (Study recruitment temporarily halted as a precautionary measure due to the COVID-19 pandemic)
First Posted : November 14, 2019
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Psoriatic Arthritis Crohn's Disease Axial Spondyloarthritis Plaque Psoriasis||Drug: Pharmacokinetics of certolizumab pegol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)|
|Actual Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
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 Name: PK
- Predose and postdose plasma certolizumab pegol (CZP) concentrations in women during pregnancy, relative to postpartum [ Time Frame: From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks) ]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.
- Plasma levels of anti-certolizumab pegol (CZP) antibodies throughout the study period [ Time Frame: From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks) ]Antibodies to CZP will be evaluated in plasma samples collected from all participants throughout the study.
- Adverse events from time of informed consent through Safety Follow-up (SFU) [ Time Frame: From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks) ]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.
- Pregnancy outcome [ Time Frame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163016
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|Study Director:||UCB Cares||001 844 599 2273 (UCB)|