Clinical trial NCT04163016: A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Official title: A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum
timeFrame: 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:
measure: Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period
timeFrame: From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
measure: Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)
timeFrame: From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
measure: Number of Participants With Pregnancy Outcome
timeFrame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Up0085 104
state: Minnesota
city: Durham
country: United States
facility: Up0085 103
state: North Carolina
city: Oklahoma City
country: United States
facility: Up0085 101
state: Oklahoma
city: Paris
country: France
facility: Up0085 500
city: Freiburg
country: Germany
facility: Up0085 202
city: Hamburg
country: Germany
facility: Up0085 201
city: Rotterdam
country: Netherlands
facility: Up0085 900
city: Barcelona
country: Spain
facility: Up0085 800
city: Bern
country: Switzerland
facility: Up0085 300
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: