NCT04163016

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-19
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2019-11-14
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

9 sites across 6 countries: United States, France, Germany, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated drug study