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

NCT04163016 | Completed Phase 1 Results FDA Drug

• 1 other identifier: UP0085
• Study Type: interventional
• Target: 22
• Locations: 6 countries
• Sites: 9

Brief 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

Keywords

Cimzia; Certolizumab Pegol; Pregnant Women; Crohn's Disease (CD); Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA); Plaque Psoriasis (PSO); Axial Spondyloarthritis (AxSpA); Pharmacokinetics; CZP

Outcome Measures

Primary Outcomes (1)

• Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum

  Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.

  Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)

Secondary Outcomes (3)

• Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period

  From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)

• Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)

  From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)

• Number of Participants With Pregnancy Outcome

  From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)

Study Arms (1)

Pharmacokinetics Sampling

EXPERIMENTAL

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

Interventions

Pharmacokinetics of certolizumab pegol DRUG

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.

Also known as: PK

Pharmacokinetics Sampling

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (9)

Up0085 104

Minneapolis, Minnesota, 55455, United States

Location

Up0085 103

Durham, North Carolina, 27710, United States

Location

Up0085 101

Oklahoma City, Oklahoma, 73104, United States

Location

Up0085 500

Paris, France

Location

Up0085 202

Freiburg im Breisgau, Germany

Location

Up0085 201

Hamburg, Germany

Location

Up0085 900

Rotterdam, Netherlands

Location

Up0085 800

Barcelona, Spain

Location

Up0085 300

Bern, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Crohn Disease; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ankylosis

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 14, 2019
• Study Start: June 19, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (3); NL (1); ES (1); CH (1); DE (2)