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

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ClinicalTrials.gov Identifier: NCT04163016
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE October 24, 2019
First Posted Date  ICMJE November 14, 2019
Last Update Posted Date February 15, 2021
Actual Study Start Date  ICMJE June 19, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
Predose and postdose plasma certolizumab pegol (CZP) concentrations in women during pregnancy, relative to postpartum [ Time Frame: From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks) ]
Mean differences with 95% confidence interval (CI) of CZP plasma concentrations between samples taken during pregnancy and baseline (postpartum samples) will be estimated within a mixed effect model using contrasts.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Plasma levels of anti-certolizumab pegol (CZP) antibodies throughout the study period [ Time Frame: From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks) ]
    Antibodies to CZP will be evaluated in plasma samples collected from all participants throughout the study.
  • Adverse events from time of informed consent through Safety Follow-up (SFU) [ Time Frame: From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks) ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
  • Pregnancy outcome [ Time Frame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks) ]
    Pregnancy outcomes will be collected via a written notification by the investigator and recorded in the Pregnancy Outcome Form. Pregnancies will be determined to end in delivery-live birth, delivery-still birth, Spontaneous abortion, or Therapeutic abortion.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Official Title  ICMJE A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Crohn's Disease
  • Axial Spondyloarthritis
  • Plaque Psoriasis
Intervention  ICMJE 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.

Other Name: PK
Study Arms  ICMJE Experimental: Pharmacokinetics Sampling

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.

Intervention: Drug: Pharmacokinetics of certolizumab pegol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com
Listed Location Countries  ICMJE Canada,   Germany,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04163016
Other Study ID Numbers  ICMJE UP0085
2019-003410-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares 001 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP