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

  • STATUS
    Recruiting
  • End date
    Jul 12, 2023
  • participants needed
    20
  • sponsor
    UCB Biopharma S.P.R.L.
Updated on 12 May 2022
tuberculosis
certolizumab pegol
interferon gamma
cimzia
bacillus calmette-guerin
purified protein derivative
interferon gamma release assay

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.

Details
Condition Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis, Plaque Psoriasis
Treatment Pharmacokinetics of certolizumab pegol
Clinical Study IdentifierNCT04163016
SponsorUCB Biopharma S.P.R.L.
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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
Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
medication
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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