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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003812-30 | EudraCT Number |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
| Parexel | INDUSTRY |
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The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic samples | Experimental | Pharmacokinetic (PK) samples will be taken from the mother at Day 0 within 24 hours before/after delivery, from the infant within 24 hours after birth, at Week 4 and Week 8 and from the umbilical cord within one hour after delivery. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling from mother | Procedure | A blood sample from the mother will be taken within 24 hours before/after the delivery. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth | Blood samples will be taken within 24 hours after birth from the infant(s). | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery | Blood samples will be taken within 24 hours before/after delivery from the mothers. | Day 0 |
| The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth |
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Inclusion Criteria:
Additional criteria to be confirmed prior to first sample from infant at Visit 2 (delivery/birth):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 11 | Scottsdale | Arizona | United States | |||
| 9 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29030361 | Result | Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13. |
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The Participant Flow refers to the Safety Set for Mothers [SS-M] and the Safety Set for Infants [SS-I]. For mothers, Baseline is defined as their screening visit. Since babies are regarded as study participants once they are born, baseline for the infants is considered to be the day of their birth.
The study started to enroll patients in January 2014 and concluded in November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SS-M | This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. |
| FG001 | SS-I |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening Period |
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| Blood sampling from infant | Procedure | Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8. |
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| Blood sampling from umbilical cord | Procedure | A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery. |
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| Certolizumab Pegol | Biological | Mothers who decided to continue on, or to start treatment with, 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.
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Blood samples were taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infant(s). Values below limit of quantification (BLQ) are replaced by values of lower limit of quantification/2=0.016 in calculations of ratios, however if both concentrations for a subject are BLQ then the ratio for that subject will not be calculated. |
| Day 0 |
| The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth | Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord | Day 0 |
| The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery | Blood samples will be taken within 24 hours before/after delivery from the mothers | Day 0 |
| The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth | Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord | Day 0 |
| Oklahoma City |
| Oklahoma |
| United States |
| 101 | Salt Lake City | Utah | United States |
| 203 | Lille | France |
| 200 | Paris | France |
| 202 | Paris | France |
| 500 | Maastricht | Netherlands |
| 20 | Bern | Switzerland |
This arm consisted of all infants born to mothers in the SS-M group.
| COMPLETED |
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| NOT COMPLETED |
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| Sampling Period |
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Baseline Characteristics refer to the Safety Set for Mothers [SS-M] and the Safety Set for Infants [SS-I]. For mothers, Baseline is defined as their screening visit. Since babies are regarded as study participants once they are born, baseline for the infants is considered to be the day of their birth.
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| ID | Title | Description |
|---|---|---|
| BG000 | SS-M | This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. |
| BG001 | SS-I | This arm consisted of all infants born to mothers in the SS-M group. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | The two groups (SS-M and SS-I) were analyzed separately. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth | Blood samples will be taken within 24 hours after birth from the infant(s). | Of the 16 infants in the SS-I, two were excluded from the Pharmacokinetic Per-Protocol Set for Infants (PK-PPS-I): one due to missing data at birth and one due to implausible PK data. | Posted | Median | Full Range | µg/mL | Day 0 |
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| Secondary | The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery | Blood samples will be taken within 24 hours before/after delivery from the mothers. | The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery. | Posted | Median | Full Range | µg/mL | Day 0 |
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| Secondary | The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth | Blood samples were taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infant(s). Values below limit of quantification (BLQ) are replaced by values of lower limit of quantification/2=0.016 in calculations of ratios, however if both concentrations for a subject are BLQ then the ratio for that subject will not be calculated. | The number of subjects' data analyzed is 28 since these are ratios for the infants and their mothers and for each ratio, we need both data. Please note that PK-PPS-I analysis set is defined as the number of infants which is 14 which is why it seems to have some discrepancies. This is due to the unique study design with mother and infant pair. | Posted | Median | Full Range | ratio | Day 0 |
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| Secondary | The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth | Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord | The Pharmacokinetic Set for Umbilical Cords (PKS-U) consisted of all umbilical cords of infants from which a CZP concentration sample was obtained at birth. | Posted | Median | Full Range | µg/mL | Day 0 |
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| Secondary | The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery | Blood samples will be taken within 24 hours before/after delivery from the mothers | The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery. | Posted | Median | Full Range | units/mL | Day 0 |
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| Secondary | The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth | Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord | The Pharmacokinetic Set for Umbilical Cords (PKS-U) consisted of all umbilical cords of infants from which a CZP concentration sample was obtained at birth. | Posted | Median | Full Range | units/mL | Day 0 |
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Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
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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 | SS-M | This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. | 0 | 21 | 7 | 21 | 3 | 21 |
| EG001 | SS-I | This arm consisted of all infants born to mothers in the SS-M group. | 0 | 16 | 2 | 16 | 4 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perineal abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
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| Vaginal laceration | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
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| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Macrosomia | General disorders | MedDRA18.1 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA18.1 | Non-systematic Assessment |
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| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
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| Candida infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
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| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D013167 | Spondylitis, Ankylosing |
| D003424 | Crohn Disease |
| D015535 | Arthritis, Psoriatic |
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| 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 |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| 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 |
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| Between 18 and 65 years |
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| >=65 years |
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| Infants |
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