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The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetics Sampling | Experimental | This study will include pregnant women who have decided to continue treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants will be responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. From all study participants blood samples will be drawn for pharmacokinetics during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetics of certolizumab pegol | Drug | The collection of blood samples for pharmacokinetics (PK) is considered interventional. Blood samples will be drawn at enrollment, predose every 4 weeks (Q4W), postdose every 8 weeks (Q8W) and postpartum predose and postdose. Study participants will be responsible for obtaining and administering commercially available approved dosing regimens of certolizumab pegol (CZP) as prescribed by each study participant's own physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum | 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. | Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
Participant is not permitted to enroll into the study if she meets any of the following TB exclusion criteria:
Study participant is taking a prohibited medication or has taken a prohibited medication
Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
Study participant had a positive or indeterminate interferon gamma release assay (IGRA) or tuberculin skin test (TST) at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0085 104 | Minneapolis | Minnesota | 55455 | United States | ||
| Up0085 103 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42012633 | Derived | Clowse MEB, Dolhain RJEM, Finzel S, Forger F, Glaser C, Pluma A, Shaughnessy L, Sidhu J, Greenin J, Rice K, Utturkar G, Duarte JN, Teil M. Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study. Rheumatol Ther. 2026 Jun;13(3):813-828. doi: 10.1007/s40744-026-00853-2. Epub 2026 Apr 21. |
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Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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The Participant Flow refers to the Enrolled Set.
The study started to enroll participants in June 2020 and concluded in May 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | CZP 200 mg Q2W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2022 | Apr 24, 2024 |
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|
|
| From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) |
| Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU) | 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. | From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) |
| Number of Participants With Pregnancy Outcome | 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. | From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks) |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Up0085 101 | Oklahoma City | Oklahoma | 73104 | United States |
| Up0085 500 | Paris | France |
| Up0085 202 | Freiburg im Breisgau | Germany |
| Up0085 201 | Hamburg | Germany |
| Up0085 900 | Rotterdam | Netherlands |
| Up0085 800 | Barcelona | Spain |
| Up0085 300 | Bern | Switzerland |
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).
| FG002 | 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). |
| FG003 | 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). |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treatment |
|
|
Baseline Characteristics refer to the Enrolled Set (ES) which consisted of all study participants who were confirmed as having signed the Informed Consent Form (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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period | 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. | 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. | Posted | Count of Participants | Participants | From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU) | 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. | Posted | Number | percentage of participants | From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pregnancy Outcome | 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. | 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. | Posted | Count of Participants | Participants | From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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). | 0 | 15 | 4 | 15 | 11 | 15 |
| EG002 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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). | 0 | 5 | 1 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (26) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Illness | General disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (26) | Non-systematic Assessment |
| |
| Perineal injury | Injury, poisoning and procedural complications | MedDRA (26) | Non-systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (26) | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (26) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Foetal vascular malperfusion | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Uterine contractions abnormal | Pregnancy, puerperium and perinatal conditions | MedDRA (26) | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (26) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2023 | Apr 24, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D003424 | Crohn Disease |
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D000844 | Ankylosis |
Not provided
Not provided
| Withdrawal by Subject |
|
| Indeterminate TB-test |
|
| Participant did not want to continue in study |
|
| 65 - <85 years |
|
| >=85 years |
|
| Male |
|
| White |
|
| Not Hispanic or Latino |
|
| Predose-Trimester 2 |
|
|
| Predose-Trimester 3 |
|
|
| Predose-Postpartum |
|
|
| Postdose-Trimester 1 |
|
|
| Postdose-Trimester 2 |
|
|
| Postdose-Trimester 3 |
|
|
| Postdose-Postpartum |
|
|
| OG001 | 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). |
| OG002 | 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). |
|
|
| OG002 | 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). |
| OG003 | 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). |
|
|
| OG002 | 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). |
| OG003 | 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). |
|
|