Axial Spondyloarthritis (AxSpA)Phase 1CRIBNCT02019602
A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
A Phase 1 study testing Blood sampling from mother, Blood sampling from infant and Blood sampling from umbilical cord in people with Axial Spondyloarthritis (AxSpA) and Non-radiographic Evidence-AxSpA, run by UCB BIOSCIENCES, Inc. at 8 sites in 4 countries.
Trial summary
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis
- What is being tested?
- Blood sampling from mother, Blood sampling from infant and Blood sampling from umbilical cord
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jan 2014to Nov 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States3 sites
9
Oklahoma City, Oklahoma
101
Salt Lake City, Utah
11
Scottsdale, Arizona
About this study
Official title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Rheumatoid Arthritis
- Being tested
- Blood sampling from mother, Blood sampling from infant, Blood sampling from umbilical cord, Certolizumab Pegol
- Keywords
- Cimzia®, CZP, Placental transfer, Autoimmune diseases and pregnancy
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Crohn Disease, Arthritis, Psoriatic, Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling from motherProcedure or surgery
A blood sample from the mother will be taken within 24 hours before/after the delivery.
Blood sampling from infantProcedure or surgery
Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
Blood sampling from umbilical cordProcedure or surgery
A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.
Certolizumab PegolBiological
Also called Cimzia®
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.
- Active Substance: Certolizumab Pegol
- Pharmaceutical Form: Solution for injection
- Concentration: 200 mg/ml
- Route of Administration: Subcutaneous Use
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic samples | Experimental | 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. Receives: Procedure: Blood sampling from mother; Procedure: Blood sampling from infant; Procedure: Blood sampling from umbilical cord; Biological: Certolizumab Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth
Blood samples will be taken within 24 hours after birth from the infant(s).
Measured: Day 0
Secondary outcomes (5)
The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery
Blood samples will be taken within 24 hours before/after delivery from the mothers.
Measured: Day 0
The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth
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.
Measured: Day 0
The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth
Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
Measured: Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery
Blood samples will be taken within 24 hours before/after delivery from the mothers
Measured: Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth
Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (AxSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019602
- Sponsor's protocol ID
- UP0017
- Other IDs
- 2013-003812-30
- Acronym
- CRIB
- Status last verified
- Mar 2019
- First submitted
- 18 Dec 2013
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.
PubMed 29030361
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
- ClinicalTrials.gov ID
- NCT02019602
- Acronym / sponsor ID
- CRIB / UP0017
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Rheumatoid Arthritis
- Keywords
- Cimzia®, CZP, Placental transfer, Autoimmune diseases and pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Parexel
- Study start
- Jan 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic samples | Experimental | Procedure: Blood sampling from mother, Procedure: Blood sampling from infant, Procedure: Blood sampling from umbilical cord, Biological: Certolizumab PegolPharmacokinetic (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling from motherA blood sample from the mother will be taken within 24 hours before/after the delivery. | Procedure or surgery | Pharmacokinetic samples |
| Blood sampling from infantBlood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8. | Procedure or surgery | Pharmacokinetic samples |
| Blood sampling from umbilical cordA blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery. | Procedure or surgery | Pharmacokinetic samples |
| Certolizumab PegolAlso: Cimzia®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. * Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection * Concentration: 200 mg/ml * Route of Administration: Subcutaneous Use | Biological | Pharmacokinetic samples |
Primary outcome
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth
Time frame: Day 0
Blood samples will be taken within 24 hours after birth from the infant(s).
5 secondary outcomes
The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery
Time frame: Day 0
The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth
Time frame: Day 0
The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth
Time frame: Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery
Time frame: Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29030361Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 877 822 9493 (UCB)
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood sampling from mother, Blood sampling from infant and Blood sampling from umbilical cord in people with Axial Spondyloarthritis (AxSpA) and Non-radiographic Evidence-AxSpA, run by UCB BIOSCIENCES, Inc. at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.