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Trial record 1 of 1 for:    NCT02019602
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A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta (CRIB)

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ClinicalTrials.gov Identifier: NCT02019602
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
PPD
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Axial Spondyloarthritis (AxSpA)
Non-radiographic Evidence-AxSpA
Ankylosing Spondylitis
Crohn's Disease
Psoriatic Arthritis
Rheumatoid Arthritis
Interventions Procedure: Blood sampling from mother
Procedure: Blood sampling from infant
Procedure: Blood sampling from umbilical cord
Biological: Certolizumab Pegol
Enrollment 37
Recruitment Details The study started to enroll patients in January 2014 and concluded in November 2016.
Pre-assignment Details The Participant Flow refers to the Safety Set for Mothers [SS-M] and the Safety Set for Infants [SS-I]. For mothers, Baseline is defined as their screening visit. Since babies are regarded as study participants once they are born, baseline for the infants is considered to be the day of their birth.
Arm/Group Title SS-M SS-I
Hide Arm/Group Description This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. This arm consisted of all infants born to mothers in the SS-M group.
Period Title: Screening Period
Started 21 16
Completed 16 16
Not Completed 5 0
Reason Not Completed
Ineligibility             4             0
Adverse Event             1             0
Period Title: Sampling Period
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title SS-M SS-I Total Title
Hide Arm/Group Description This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. This arm consisted of all infants born to mothers in the SS-M group. [Not Specified]
Overall Number of Baseline Participants 21 16 37
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set for Mothers [SS-M] and the Safety Set for Infants [SS-I]. For mothers, Baseline is defined as their screening visit. Since babies are regarded as study participants once they are born, baseline for the infants is considered to be the day of their birth.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 16 participants 37 participants
<=18 years
0
   0.0%
16
 100.0%
16
  43.2%
Between 18 and 65 years
21
 100.0%
0
   0.0%
21
  56.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Mothers Number Analyzed 21 participants 0 participants 21 participants
31.4  (5.0) 31.4  (5.0)
Infants Number Analyzed 0 participants 16 participants 16 participants
0  (0) 0  (0)
[1]
Measure Analysis Population Description: The two groups (SS-M and SS-I) were analyzed separately.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 16 participants 37 participants
Female
21
 100.0%
10
  62.5%
31
  83.8%
Male
0
   0.0%
6
  37.5%
6
  16.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 16 participants 37 participants
White
21
 100.0%
16
 100.0%
37
 100.0%
1.Primary Outcome
Title The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth
Hide Description Blood samples will be taken within 24 hours after birth from the infant(s).
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 16 infants in the SS-I, two were excluded from the Pharmacokinetic Per-Protocol Set for Infants (PK-PPS-I): one due to missing data at birth and one due to implausible PK data.
Arm/Group Title PK-PPS-I
Hide Arm/Group Description:
This arm consisted of all infants from the SS-I analysis set who provided a CZP concentration sample at birth and had no important protocol deviations that would have impacted the primary PK analysis.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0422)
[1]
NA = below limit of quantification.
2.Secondary Outcome
Title The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery
Hide Description Blood samples will be taken within 24 hours before/after delivery from the mothers.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery.
Arm/Group Title PKS-M
Hide Arm/Group Description:
This arm consisted of all mothers from the SS-M analysis set who provided the CZP concentration sample at delivery.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: µg/mL
24.40
(4.96 to 49.4)
3.Secondary Outcome
Title The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth
Hide Description 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.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects' data analyzed is 28 since these are ratios for the infants and their mothers and for each ratio, we need both data. Please note that PK-PPS-I analysis set is defined as the number of infants which is 14 which is why it seems to have some discrepancies. This is due to the unique study design with mother and infant pair.
Arm/Group Title PK-PPS-I
Hide Arm/Group Description:
This arm consisted of all infants from the SS-I analysis set who provided a CZP concentration sample at birth and had no important protocol deviations that would have impacted the primary PK analysis.
Overall Number of Participants Analyzed 28
Median (Full Range)
Unit of Measure: ratio
0.0007634
(0.000403 to 0.00323)
4.Secondary Outcome
Title The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth
Hide Description Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set for Umbilical Cords (PKS-U) consisted of all umbilical cords of infants from which a CZP concentration sample was obtained at birth.
Arm/Group Title PKS-U
Hide Arm/Group Description:
This arm consisted of all umbilical cords of infants from the SS-I analysis set from which a CZP concentration sample was obtained at birth.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0477)
[1]
NA = below limit of quantification.
5.Secondary Outcome
Title The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery
Hide Description Blood samples will be taken within 24 hours before/after delivery from the mothers
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery.
Arm/Group Title PKS-M
Hide Arm/Group Description:
This arm consisted of all mothers from the SS-M analysis set who provided the CZP concentration sample at delivery.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: units/mL
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
6.Secondary Outcome
Title The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth
Hide Description Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set for Umbilical Cords (PKS-U) consisted of all umbilical cords of infants from which a CZP concentration sample was obtained at birth.
Arm/Group Title PKS-U
Hide Arm/Group Description:
This arm consisted of all umbilical cords of infants from the SS-I analysis set from which a CZP concentration sample was obtained at birth.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: units/mL
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
Time Frame Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SS-M SS-I
Hide Arm/Group Description This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. This arm consisted of all infants born to mothers in the SS-M group.
All-Cause Mortality
SS-M SS-I
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
SS-M SS-I
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/21 (33.33%)      2/16 (12.50%)    
General disorders     
Macrosomia * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Perineal abscess * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Infection * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
Injury, poisoning and procedural complications     
Vaginal laceration * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
Pregnancy, puerperium and perinatal conditions     
Arrested labour * 1  2/21 (9.52%)  2 0/16 (0.00%)  0
Gestational diabetes * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Placental insufficiency * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Polyhydramnios * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Premature baby * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Prolonged labour * 1  1/21 (4.76%)  1 0/16 (0.00%)  0
Meconium in amniotic fluid * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
1
Term from vocabulary, MedDRA18.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SS-M SS-I
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/21 (14.29%)      4/16 (25.00%)    
Gastrointestinal disorders     
Constipation * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
Gastrooesophageal reflux disease * 1  0/21 (0.00%)  0 2/16 (12.50%)  2
Hepatobiliary disorders     
Jaundice * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Candida infection * 1  0/21 (0.00%)  0 2/16 (12.50%)  2
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis * 1  3/21 (14.29%)  3 0/16 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Foetal hypokinesia * 1  0/21 (0.00%)  0 1/16 (6.25%)  1
Umbilical cord around neck * 1  0/21 (0.00%)  0 2/16 (12.50%)  2
1
Term from vocabulary, MedDRA18.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT02019602    
Other Study ID Numbers: UP0017
2013-003812-30 ( EudraCT Number )
First Submitted: December 18, 2013
First Posted: December 24, 2013
Results First Submitted: November 21, 2017
Results First Posted: June 21, 2019
Last Update Posted: June 21, 2019