A Multicenter, Postmarketing Study Evaluating the Concent... | NCT02154425

NCT02154425

ID	Type	Description	Link
2013-004126-28	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
PPD Development, LP	INDUSTRY
Parexel	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pharmacokinetic samples	Experimental	Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose if Q2W dosing), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP). 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.	Procedure: Breast milk sampling Biological: Certolizumab Pegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast milk sampling	Procedure	Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose for mothers on CZP Q2W), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0	Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.	Day 0
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2	Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.	Day 2
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4	Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.	Day 4
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6	Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.	Day 6
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8	Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.	Day 8
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10	Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.	Day 10
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12	Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An IRB/IEC approved written Informed Consent form for participation of the maternal subject and her infant (for collection of infant demographic and AE data) is signed and dated by the subject. Where applicable, the written Informed Consent form with respect to the infant 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 and at least 18 years of age at the time of providing consent
Subject has delivered term infant(s) (at least 37 weeks gestation)
Subject is being treated with Certolizumab Pegol (CZP) per the current approved prescribing information
The decision to treat with CZP or to breastfeed is made independently from and prior to the subject consenting to participate in this study
Subject agrees to use only the emollient or nipple cream provided by the Sponsor for use during the Sampling Period as described per protocol
Subject is at least 6 weeks postpartum
Subject is on an established dosing regimen of CZP (at least the third dose of CZP since starting/restarting CZP)

Exclusion Criteria:

Subject is pregnant or plans to become pregnant during the study
Subject is taking a prohibited medication or has taken a prohibited medication Note: any subjects requiring antibiotics must be discussed with the Medical Monitor prior to enrollment
Subject has history of chronic alcohol abuse or drug abuse in the last year
In subjects who intend to breastfeed, the infant has any abnormality noted on physical examination that, in the opinion of the Investigator, may jeopardize or compromise the subject's ability to participate in this study
Subject has any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or the outcome of the pregnancy (as applicable). Note: subjects with mastitis infection should not have samples collected until the infection is completely resolved
Subject has history of breast implants, breast augmentation, or breast reduction surgery
Subject has previously participated in this study
Subject has participated in a study of an investigational medicinal product (IMP) (or a 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 a medical device) unless the study is UCB UP0017 [NCT02019602] or a registry study
Subject has received treatment with any biological therapeutic agent, or other anti-TNF agents with the exception of CZP, within 5 half-lives prior to obtaining the first sample
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 (LTB) infection. If tested within the 6 months prior to screening and test was negative for TB, and there is no change in the patient's clinical status, nor social, family, or travel history, there is no need for an additional TB testing at screening

Contacts/Locations Module

Name	Affiliation	Role
UCB Cares	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
7		Los Angeles	California		United States
1

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28814432	Result	Clowse ME, Forger F, Hwang C, Thorp J, Dolhain RJ, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Toublanc N, Wang M, Hale TW. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017 Nov;76(11):1890-1896. doi: 10.1136/annrheumdis-2017-211384. Epub 2017 Aug 16.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Mothers (SS)	This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The Safety Set consisted of all participating mothers who had received at least 1 dose of CZP.

ID	Title	Description
BG000	Mothers (SS)	This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).

Units	Counts
Participants	BG00018

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG00018
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

arithmetic mean (standard deviation)

Title	Measurements
	BG00033.7± 4.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00018
Male	BG0000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0

Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 0

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants	OG00016 OG0011

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to 0.0571)NA = below limit of quantification. OG001NA(NA to NA)NA = below limit of quantification.

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2

Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 2

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4

Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 4

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6

Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 6

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8

Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 8

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10

Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 10

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12

Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 12

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14

Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Mean

Full Range

µg/mL

Day 14

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q2W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
OG001	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants

Primary

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28

In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

µg/mL

Day 28

ID	Title	Description
OG000	Mothers CZP (PK-PPS) Q4W	This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2

Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 2

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4

Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 4

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6

Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 6

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8

Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 8

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10

Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 10

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12

Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 12

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14

Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

Day 14

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28

In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.

Posted

Median

Full Range

mg/kg/day

Day 28

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Primary

The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)

Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.

The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Posted

Median

Full Range

mg/kg/day

From Day 0 to Day 14 or 28

ID	Title	Description
OG000	All Mothers (PK-PPS)	This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SS-M	This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).			1	18	9	18
EG001	SS-I	This arm consisted of all infants of mothers in the SS-M.			0	17	8	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Breast abscess	Infections and infestations	MedDRA18.1	Non-systematic Assessment		EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Exacerbation of Crohn's disease	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0013 events3 affected17 at risk
Candida infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected17 at risk
Herpes zoster	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Pneumonia	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Headache	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected17 at risk
Galactostasis	Reproductive system and breast disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Nipple disorder	Reproductive system and breast disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected17 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected17 at risk
Vomiting	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected17 at risk
Nasopharyngitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0014 events4 affected17 at risk
Lichen striatus	Skin and subcutaneous tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected17 at risk

ID	Term
D000089183	Axial Spondyloarthritis
D013167	Spondylitis, Ankylosing
D003424	Crohn Disease
D015535	Arthritis, Psoriatic
D001172	Arthritis, Rheumatoid
D001942	Breast Feeding
D001327	Autoimmune Diseases

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D000844	Ankylosis
D007592	Joint Diseases
D001168	Arthritis
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases
D011565	Psoriasis
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D007154	Immune System Diseases
D005247	Feeding Behavior
D001519	Behavior

ID	Term
D000068582	Certolizumab Pegol

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins