CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Pharmacokinetics of certolizumab pegoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04163016
NCT04163016Phase 1Completed
CompareCT.gov

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

UCB Biopharma SRL·interventional·Posted Nov 14, 2019·Updated Sep 19, 2024

In Brief

A Phase 1 clinical trial evaluating Pharmacokinetics of certolizumab pegol for Rheumatoid Arthritis and 4 related conditions. Completed, enrolled 22 participants across 9 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis, Plaque Psoriasis
CountriesFrance, Germany, Netherlands, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 14, 2019
Enrollment StartJun 19, 2020
Primary CompletionMay 23, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.6 years ago

Interventions

Pharmacokinetics of certolizumab pegoldrug

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.