Trial Outcomes & Findings for A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta (NCT NCT02019602)

NCT ID: NCT02019602

Last Updated: 2019-06-21

Results Overview

Blood samples will be taken within 24 hours after birth from the infant(s).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 37 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2019-06-21

Participant Flow

The study started to enroll patients in January 2014 and concluded in November 2016.

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.

Participant milestones

Measure	SS-M 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.	SS-I This arm consisted of all infants born to mothers in the SS-M group.
Screening Period STARTED	21	16
Screening Period COMPLETED	16	16
Screening Period NOT COMPLETED	5	0
Sampling Period STARTED	16	16
Sampling Period COMPLETED	16	16
Sampling Period NOT COMPLETED	0	0

Reasons for withdrawal

Measure	SS-M 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.	SS-I This arm consisted of all infants born to mothers in the SS-M group.
Screening Period Ineligibility	4	0
Screening Period Adverse Event	1	0

Baseline Characteristics

The two groups (SS-M and SS-I) were analyzed separately.

Baseline characteristics by cohort

Measure	SS-M n=21 Participants 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.	SS-I n=16 Participants This arm consisted of all infants born to mothers in the SS-M group.	Total Title n=37 Participants
Age, Categorical <=18 years	0 Participants n=21 Participants	16 Participants n=16 Participants	16 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants	0 Participants n=16 Participants	21 Participants n=37 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants	0 Participants n=16 Participants	0 Participants n=37 Participants
Age, Continuous Mothers	31.4 years STANDARD_DEVIATION 5.0 • n=21 Participants • The two groups (SS-M and SS-I) were analyzed separately.	—	31.4 years STANDARD_DEVIATION 5.0 • n=21 Participants • The two groups (SS-M and SS-I) were analyzed separately.
Age, Continuous Infants	—	0 years STANDARD_DEVIATION 0 • n=16 Participants • The two groups (SS-M and SS-I) were analyzed separately.	0 years STANDARD_DEVIATION 0 • n=16 Participants • The two groups (SS-M and SS-I) were analyzed separately.
Sex: Female, Male Female	21 Participants n=21 Participants	10 Participants n=16 Participants	31 Participants n=37 Participants
Sex: Female, Male Male	0 Participants n=21 Participants	6 Participants n=16 Participants	6 Participants n=37 Participants
Race/Ethnicity, Customized White	21 Participants n=21 Participants	16 Participants n=16 Participants	37 Participants n=37 Participants

PRIMARY outcome

Timeframe: Day 0

Population: 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.

Blood samples will be taken within 24 hours after birth from the infant(s).

Outcome measures

Measure	PK-PPS-I n=14 Participants 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.
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth	NA µg/mL Interval to 0.0422 NA = below limit of quantification.

SECONDARY outcome

Timeframe: Day 0

Population: The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery.

Blood samples will be taken within 24 hours before/after delivery from the mothers.

Outcome measures

Measure	PK-PPS-I n=16 Participants 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.
The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery	24.40 µg/mL Interval 4.96 to 49.4

SECONDARY outcome

Timeframe: Day 0

Population: 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.

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.

Outcome measures

Measure	PK-PPS-I n=28 Participants 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.
The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth	0.0007634 ratio Interval 0.000403 to 0.00323

SECONDARY outcome

Timeframe: Day 0

Population: 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.

Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord

Outcome measures

Measure	PK-PPS-I n=15 Participants 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.
The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth	NA µg/mL Interval to 0.0477 NA = below limit of quantification.

SECONDARY outcome

Timeframe: Day 0

Population: The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery.

Blood samples will be taken within 24 hours before/after delivery from the mothers

Outcome measures

Measure	PK-PPS-I n=16 Participants 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.
The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery	NA units/mL NA = below limit of quantification.

SECONDARY outcome

Timeframe: Day 0

Population: 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.

Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord

Outcome measures

Measure	PK-PPS-I n=15 Participants 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.
The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth	NA units/mL NA = below limit of quantification.

Adverse Events

SS-M

Serious events: 7 serious events

Other events: 3 other events

Deaths: 0 deaths

SS-I

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	SS-M n=21 participants at risk 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.	SS-I n=16 participants at risk This arm consisted of all infants born to mothers in the SS-M group.
Infections and infestations Perineal abscess	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Injury, poisoning and procedural complications Vaginal laceration	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Arrested labour	9.5% 2/21 • Number of events 2 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Gestational diabetes	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Placental insufficiency	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Polyhydramnios	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Premature baby	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Prolonged labour	4.8% 1/21 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
General disorders Macrosomia	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Infections and infestations Infection	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)

Other adverse events

Measure	SS-M n=21 participants at risk 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.	SS-I n=16 participants at risk This arm consisted of all infants born to mothers in the SS-M group.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	14.3% 3/21 • Number of events 3 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	0.00% 0/16 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Gastrointestinal disorders Constipation	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	12.5% 2/16 • Number of events 2 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Hepatobiliary disorders Jaundice	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Infections and infestations Candida infection	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	12.5% 2/16 • Number of events 2 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	6.2% 1/16 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Pregnancy, puerperium and perinatal conditions Umbilical cord around neck	0.00% 0/21 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)	12.5% 2/16 • Number of events 2 • Adverse Events were collected during the whole study period (from Week 0 up to Week 25)

Additional Information

UCB

Cares

Phone: +1844 599

Email: UCBCares@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60