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

Rheumatoid Arthritis Clinical Trial

— CHERISH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163016
• Other study ID #: UP0085
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2020
• Est. completion date: May 23, 2023

Study information

• Verified date: June 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Crohn Disease
• Crohn's Disease
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis

Intervention

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.

Locations

Country	Name	City	State
France	Up0085 500	Paris
Germany	Up0085 202	Freiburg
Germany	Up0085 201	Hamburg
Netherlands	Up0085 900	Rotterdam
Spain	Up0085 800	Barcelona
Switzerland	Up0085 300	Bern
United States	Up0085 103	Durham	North Carolina
United States	Up0085 104	Minneapolis	Minnesota
United States	Up0085 101	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  France,  Germany,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)