- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02019602
A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta (CRIB)
A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Lille, France
- 203
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Paris, France
- 200
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Paris, France
- 202
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-
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Maastricht, Netherlands
- 500
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-
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Bern, Switzerland
- 20
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Arizona
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Scottsdale, Arizona, United States
- 11
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Oklahoma
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Oklahoma City, Oklahoma, United States
- 9
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Utah
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Salt Lake City, Utah, United States
- 101
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- An IRB/IEC approved written Informed Consent form for the maternal subject and her infant(s) is signed and dated by the subject. Where applicable, the written Informed Consent form with respect to the infant(s) is also signed and dated by the holder of parental rights as designated by the maternal subject
- Subject is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator
- Subject is female ≥18 years at the time of informed consent
- Subject is ≥30 weeks pregnant with a singleton or twins at the time of informed consent
- Subject is being treated with Certolizumab Pegol (CZP) per the current approved prescribing Information
- Subject started or decided to continue treatment with CZP independently from and prior to participating in this study and in accordance with the treating physician
- Subject expects to receive CZP until at least 35 days prior to expected delivery (date of injection counted as Day 1)
Additional criteria to be confirmed prior to first sample from infant at Visit 2 (delivery/birth):
- Subject delivers a live born infant(s) at or near term (≥34 weeks gestation )
- Subject received CZP within 35 days before delivery (date of injection counted as Day 1)
- Subject has not received contraindicated medication
Exclusion Criteria:
- Subject has participated in a study of an investigational medicinal product (IMP) or medical device within the previous 30 days or 5 half-lives (whichever is longer) prior to Screening or is currently participating in another study of an IMP or medical device - unless the study is UCB UP0016 [NCT02154425] or a registry study
- Subject has any obstetrical or psychiatric condition, or she or her infant(s) has any medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study or the outcome of the pregnancy
- Subject has history of chronic alcohol abuse or drug abuse during pregnancy
- Subject has any pregnancy-related clinically significant abnormality noted on obstetric ultrasound, or other imaging assessment, or the subject has significant laboratory abnormalities during her pregnancy, as judged by the Investigator
- Subject is taking or has taken any medication with strong positive evidence of a human fetal risk of teratogenicity (e.g., methotrexate or leflunomide) during pregnancy
- Subject has evidence of a condition suggesting chronic or acute uteroplacental insufficiency such as intrauterine growth restriction, severe maternal hypertensive disorders of pregnancy, or abruption
- Subject has a documented history of primary or secondary antiphospholipid syndrome or hypercoagulable state
- Subject has received treatment with any biological therapeutic agent, including anti-TNFs other than certolizumab pegol (CZP), during pregnancy
- Subject has previously participated in this study
- Subject has a positive or indeterminate QuantiFERON®-TB GOLD In Tube test at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the subject
- Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection (LTB). If tested within the 6 months prior to Screening and the test was negative for TB, and there is no change in the subject's clinical status, nor social, family, or travel history, there is no need for an additional TB testing at Screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmacokinetic samples
Pharmacokinetic (PK) samples will be taken from the mother at Day 0 within 24 hours before/after delivery, from the infant within 24 hours after birth, at Week 4 and Week 8 and from the umbilical cord within one hour after delivery. Included are mothers who decided to continue on, or to start treatment with certolizumab pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label. |
A blood sample from the mother will be taken within 24 hours before/after the delivery.
Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.
Mothers who decided to continue on, or to start treatment with, CZP for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth
Time Frame: Day 0
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Blood samples will be taken within 24 hours after birth from the infant(s).
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Day 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery
Time Frame: Day 0
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Blood samples will be taken within 24 hours before/after delivery from the mothers.
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Day 0
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The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth
Time Frame: Day 0
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Blood samples were taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infant(s).
Values below limit of quantification (BLQ) are replaced by values of lower limit of quantification/2=0.016 in calculations of ratios, however if both concentrations for a subject are BLQ then the ratio for that subject will not be calculated.
|
Day 0
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The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth
Time Frame: Day 0
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Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
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Day 0
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The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery
Time Frame: Day 0
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Blood samples will be taken within 24 hours before/after delivery from the mothers
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Day 0
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The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth
Time Frame: Day 0
|
Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
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Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Infections
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Gastroenteritis
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Psoriasis
- Bone Diseases, Infectious
- Ankylosis
- Arthritis
- Crohn Disease
- Arthritis, Psoriatic
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Certolizumab Pegol
Other Study ID Numbers
- UP0017
- 2013-003812-30 (EudraCT Number)
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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