Trial Outcomes & Findings for A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) (NCT NCT04163016)

Last Updated: 2024-09-19

Results Overview

Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

22 participants

Primary outcome timeframe

Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)

Results posted on

2024-09-19

Participant Flow

The study started to enroll participants in June 2020 and concluded in May 2023.

The Participant Flow refers to the Enrolled Set.

Participant milestones

Participant milestones
Measure	Not Dosed This arm included participant who signed the Informed Consent Form (ICF) but withdrew from the study prior to taking a dose of commercial certolizumab pegol (CZP) after enrollment.	CZP 200 mg Q2W The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Enrollment STARTED	1	15	1	5
Enrollment COMPLETED	0	15	1	5
Enrollment NOT COMPLETED	1	0	0	0
Treatment STARTED	0	15	1	5
Treatment COMPLETED	0	12	1	3
Treatment NOT COMPLETED	0	3	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Not Dosed This arm included participant who signed the Informed Consent Form (ICF) but withdrew from the study prior to taking a dose of commercial certolizumab pegol (CZP) after enrollment.	CZP 200 mg Q2W The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Enrollment Adverse Event	1	0	0
Treatment Adverse Event	0	1	0
Treatment Withdrawal by Subject	0	2	0
Treatment Indeterminate TB-test	0	0	1
Treatment Participant did not want to continue in study	0	0	1

Baseline Characteristics

A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Not Dosed This arm included participant who signed the Informed Consent Form (ICF) but withdrew from the study prior to taking a dose of commercial certolizumab pegol (CZP) after enrollment.	CZP 200 mg Q2W n=15 Participants The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W n=5 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	Total n=20 Participants Total of all reporting groups
Age, Customized 18 - <65 years	0 Participants n=5 Participants	15 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Age, Customized 65 - <85 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized >=85 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	15 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	14 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	0 Participants n=5 Participants	15 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants

PRIMARY outcome

Timeframe: Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Safety Set (SS) which included those study participants for whom at least one predose or postdose sample was available which was not impacted by an important protocol deviation. Here, number analyzed signifies participants who were evaluable at specified time points. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'CZP 400 mg Q2W' arm.

Outcome measures

Outcome measures
Measure	CZP 200 mg Q2W n=15 Participants The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W n=4 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Predose-Trimester 1	15.251 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 68.1	—	NA microgram per milliliter (μg/mL) Geometric Coefficient of Variation NA As pre-specified in the Statistical Analysis Plan, Geometric Means and Geometric Coefficient of Variation are only calculated if at least 2/3 of the concentrations are above lower limit of quantification (LLOQ) (0.032 ug/mL) and n is greater than or equal to (\>=) 4. NA replaces summary statistics when the sample size is N=3 or N\<3.	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Predose-Trimester 2	16.916 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 39.9	—	9.027 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 107.2	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Predose-Trimester 3	16.827 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 41.0	—	2.759 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 3193.5	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Predose-Postpartum	22.318 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 41.1	—	NA microgram per milliliter (μg/mL) Geometric Coefficient of Variation NA As pre-specified in the Statistical Analysis Plan, Geometric Means and Geometric Coefficient of Variation are only calculated if at least 2/3 of the concentrations are above lower limit of quantification (LLOQ) (0.032 ug/mL) and n is greater than or equal to (\>=) 4. NA replaces summary statistics when the sample size is N=3 or N\<3.	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Postdose-Trimester 1	20.046 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 54.3	—	—	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Postdose-Trimester 2	22.961 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 44.9	—	46.094 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 14.6	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Postdose-Trimester 3	25.001 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 39.7	—	8.105 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 19481.3	—
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum Postdose-Postpartum	30.153 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 47.2	—	NA microgram per milliliter (μg/mL) Geometric Coefficient of Variation NA As pre-specified in the Statistical Analysis Plan, Geometric Means and Geometric Coefficient of Variation are only calculated if at least 2/3 of the concentrations are above lower limit of quantification (LLOQ) (0.032 ug/mL) and n is greater than or equal to (\>=) 4. NA replaces summary statistics when the sample size is N=3 or N\<3.	—

SECONDARY outcome

Timeframe: From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)

Population: The Safety Set (SS) included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'CZP 400 mg Q2W' arm.

Antibodies to CZP were evaluated in plasma samples collected from all participants throughout the study. Anti-CZP antibodies (ADAb) were measured using a three-tiered assay approach: screening, confirmatory and titration assay. Samples that were confirmed as positive in the screening and confirmatory assay were evaluated in a titration assay to quantify the ADAb level and were reported as titer (reciprocal dilution factor including minimum required dilution \[MRD\]). Sample values that were 'positive screen' and 'positive immunodepletion' were defined as ADAb positive. Once determined positive, a study participant's highest titer was used to categorize ("titer classification") the study participant as follows: Positive less than or equal to (=)32, Positive greater than (\>)32 - =128, Positive \>128 - =512, Positive \>512 - =1024, Positive \>1024 - =4096, and Positive \>4096.

Outcome measures

Outcome measures
Measure	CZP 200 mg Q2W n=15 Participants The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W n=5 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period Positive ≤32	0 Participants	—	0 Participants	—
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period Positive >32 to ≤128	0 Participants	—	0 Participants	—
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period Positive >128 to ≤512	1 Participants	—	0 Participants	—
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period Positive >512 to ≤1024	0 Participants	—	1 Participants	—
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period Positive >1024 to ≤4096	5 Participants	—	1 Participants	—
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period Positive >4096	8 Participants	—	2 Participants	—

SECONDARY outcome

Timeframe: From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)

Population: The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP.

Outcome measures

Outcome measures
Measure	CZP 200 mg Q2W The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W n=15 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W n=5 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)	—	86.7 percentage of participants	—	60.0 percentage of participants

SECONDARY outcome

Timeframe: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)

Population: The Enrolled set included all participants who were confirmed as having signed the ICF to participate in the study and had provided the first blood sample. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.

Pregnancy outcomes were collected via a written notification by the investigator and recorded in the Pregnancy Outcome Form. Pregnancies were determined to end in delivery-live birth, delivery-still birth, spontaneous abortion, therapeutic abortion, or missing data.

Outcome measures

Outcome measures
Measure	CZP 200 mg Q2W The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W n=15 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W n=5 Participants The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Number of Participants With Pregnancy Outcome Delivery, live birth	—	12 Participants	—	4 Participants
Number of Participants With Pregnancy Outcome Delivery, still birth	—	0 Participants	—	0 Participants
Number of Participants With Pregnancy Outcome Spontaneous abortion	—	0 Participants	—	0 Participants
Number of Participants With Pregnancy Outcome Therapeutic abortion	—	0 Participants	—	0 Participants
Number of Participants With Pregnancy Outcome Missing	—	3 Participants	—	1 Participants

Adverse Events

Not Dosed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CZP 200 mg Q2W

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

CZP 400 mg Q2W

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CZP 400 mg Q4W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Not Dosed This arm included participant who signed the Informed Consent Form (ICF) but withdrew from the study prior to taking a dose of commercial certolizumab pegol (CZP) after enrollment.	CZP 200 mg Q2W n=15 participants at risk The study included pregnant women who continued treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 200 milligrams (mg) every 2 weeks (Q2W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q2W The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg Q2W, as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).	CZP 400 mg Q4W n=5 participants at risk The study included pregnant women who continued treatment with commercial CZP in accordance with their treating physician prior to participating in the study. Study participants were responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. Participants took commercial CZP 400 mg every 4 weeks (Q4W), as subcutaneous injection, during the pregnancy period (up to 40 weeks) and post-partum period (up to 13 weeks after delivery).
Metabolism and nutrition disorders Hyponatraemia	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	6.7% 1/15 • Number of events 1 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/5 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.
Pregnancy, puerperium and perinatal conditions Abortion missed	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/15 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/5 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.
Pregnancy, puerperium and perinatal conditions Foetal death	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	6.7% 1/15 • Number of events 1 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/5 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/15 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	20.0% 1/5 • Number of events 1 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	6.7% 1/15 • Number of events 1 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/5 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.
Pregnancy, puerperium and perinatal conditions Small for dates baby	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/15 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/5 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.
Vascular disorders Haemorrhage	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	6.7% 1/15 • Number of events 1 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	— 0/0 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.	0.00% 0/5 • From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP. The SS included all enrolled study participants who received at least 1 dose of CZP after Screening. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: GT60