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Trial record 1 of 1 for:    NCT04163016
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A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) (CHERISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163016
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Psoriatic Arthritis Crohn's Disease Axial Spondyloarthritis Plaque Psoriasis Drug: Pharmacokinetics of certolizumab pegol Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163016


Contacts
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Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
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United States, Minnesota
Up0085 104 Recruiting
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Up0085 103 Recruiting
Durham, North Carolina, United States, 27710
United States, Oklahoma
Up0085 101 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Up0085 102 Recruiting
Houston, Texas, United States, 77030
Canada
Up0085 600 Withdrawn
Toronto, Canada
Switzerland
Up0085 300 Recruiting
Bern, Switzerland
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT04163016    
Other Study ID Numbers: UP0085
2019-003410-13 ( EudraCT Number )
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Cimzia
Certolizumab Pegol
Pregnant Women
Crohn's Disease (CD)
Rheumatoid Arthritis (RA)
Psoriatic Arthritis (PsA)
Plaque Psoriasis (PSO)
Axial Spondyloarthritis (AxSpA)
Pharmacokinetics
CZP
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylarthritis
Crohn Disease
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents