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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507379-23-00 | EU Trial (CTIS) Number |
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The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.
Participants will receive efgartigimod IV or efgartigimod PH20 SC, using the dose administered in the antecedent studies. Participants who have not reached the age of 18 can remain in the study until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG. Participants who have reached the age of 18 can remain in the study for a maximum of 2 years, until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod or Efgartigimod PH20 SC | Experimental | Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod IV or Efgartigimod PH20 SC | Biological | Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs, SAEs and AESIs | AE : adverse event; SAE : serious adverse event; AESI : adverse event of special interest | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ADAs against efgartigimod | ADA : anti-drug antibody | Up to 4 years |
| Incidence of antibodies against rHuPH20 | rHuPH20: recombinant human hyaluronidase PH20 |
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Inclusion Criteria:
The participant completed ARGX-113-2006, defined as:
Either the participant or the participant's legally authorized representative can understand the requirements of the trial and provide written informed consent/assent, and willingness and ability to comply with the trial protocol procedures.
Contraceptive use for sexually active participants should be consistent with local regulations for those participating in clinical studies.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital | Chicago | Illinois | 60611 | United States | ||
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| Up to 4 years |
| Atrium Health Neurology Specialty Care |
| Charlotte |
| North Carolina |
| 28207 |
| United States |
| University of Virginia (UVA) Health - Developmental Pediatrics Clinic | Charlottesville | Virginia | 22903 | United States |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Childrens Hospital of Eastern Ontario | Ottawa | K1H 8L1 | Canada |
| AP-HM- Hôpital de La Timone | Marseille | 13005 | France |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Hadassah Medical Center- Ein Kerem | Jerusalem | 9112001 | Israel |
| Leids Universitair Medisch Centrum | Leiden | 2333 ZA | Netherlands |
| Uniwersyteckie Centrum Kliniczne w Gdansku | Gdansk | 80-211 | Poland |
| Wielospecjalistyczna Poradnia Lekarska Synapsis | Katowice | 40-123 | Poland |
| Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM | Warsaw | 02-097 | Poland |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital - Pediatric Neurology | London | WC1N 3JH | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| 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 |
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