- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163016
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) (CHERISH)
A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Paris, France
- Up0085 500
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Freiburg, Germany
- Up0085 202
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Hamburg, Germany
- Up0085 201
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Rotterdam, Netherlands
- Up0085 900
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Barcelona, Spain
- Up0085 800
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Bern, Switzerland
- Up0085 300
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Up0085 104
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North Carolina
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Durham, North Carolina, United States, 27710
- Up0085 103
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Up0085 101
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. |
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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.
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From Enrollment to End of Post-Partum Period (Duration of pregnancy + 13 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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Antibodies to CZP will be evaluated in plasma samples collected from all participants throughout the study.
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From Enrollment to Safety Follow-up (Duration of pregnancy + 18 weeks)
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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)
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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.
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From Screening to Safety Follow-up (Duration of pregnancy + 18 weeks)
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Pregnancy outcome
Time Frame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)
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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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From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Arthritis
- Arthritis, Rheumatoid
- Psoriasis
- Crohn Disease
- Arthritis, Psoriatic
- Spondylitis
- Spondylarthritis
- Axial Spondyloarthritis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tumor Necrosis Factor Inhibitors
- Certolizumab Pegol
Other Study ID Numbers
- UP0085
- 2019-003410-13 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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