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This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Pregnancy | woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy |
| |
| Prospective Pregnancy | woman is pregnant or breastfeeding at time of study enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod | Biological | Efgartigimod IV or SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcomes | Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery) | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Congenital malformations | Congenital malformations (CDC 2020b) identified in the developing fetus, neonate, or infant: Major congenital malformations (MCMs); Minor congenital malformations | up to 10 years |
| The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness) |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women or women no longer pregnant at the time of study enrollment but exposed to efgartigimod any time within 25 days prior to conception or any time during the pregnancy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | Clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United BioSource LLC | Recruiting | Morgantown | West Virginia | 26508 | United States |
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Other events of interest identified in the developing neonate and infant (Hospitalizations for serious illness; Potential adverse reactions to medications; Growth and development milestones as described by the Centers for Disease Control and Prevention or other accepted standard assessments; Infant developmental deficiency; Postnatal growth deficiency or failure to thrive (FTT); Neonatal and infant mortality; Infections; Transient neonatal myasthenia; Vaccination and vaccine reactions |
| up to 10 years |
| Maternal complications of pregnancy | Maternal complications of pregnancy, including but not limited to: Premature rupture of membranes (PROM); Preterm PROM (PPROM); Pre-eclampsia; Gestational hypertension; Eclampsia; Proteinuria; Gestational diabetes; Intrauterine growth restriction (IUGR); Polyhdramnios | up to 10 years |
| Maternal infections | up to 10 years |
| The number of observed fetal growth deficiency | up to 10 years |
| Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1) | Recruiting | Bochum | 44791 | Germany |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
|
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011129 | Polyradiculoneuropathy |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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