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ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs).
The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration.
Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISA1 participants | Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod IV | Biological | Intravenous infusion of efgartigimod |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes | Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes | Each ISA record will specify the correct scale and time point | Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
| 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 |
|---|---|---|---|---|---|---|
| Profound Research LLC - Carlsbad | Recruiting | Carlsbad | California | 92011 | United States |
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| Empasiprubart IV |
| Biological |
Intravenous infusion of empasiprubart |
|
| Visionary Investigators Network | Recruiting | Miami | Florida | 33133 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33620 | United States |
|
| Erlanger Health System | Recruiting | Columbia | Maryland | 21044 | United States |
|
| Henry Ford Health System | Active, not recruiting | Detroit | Michigan | 48202-2608 | United States |
| Dent Neurologic Institute - Amherst | Recruiting | Amherst | New York | 14226 | United States |
|
| Duke Early Phase Clinical Research Unit - PPDS | Active, not recruiting | Durham | North Carolina | 27710-0001 | United States |
| Ohio State Martha Morehouse Outpatient Care | Recruiting | Columbus | Ohio | 43221-3502 | United States |
|
| Erlanger Health System | Recruiting | Chattanooga | Tennessee | 37403-2136 | United States |
|
| National Neuromuscular Research Institute | Recruiting | Austin | Texas | 78759 | United States |
|
| University of Texas- San Antonio - Health Science Center - PPDS | Recruiting | San Antonio | Texas | 78229 | United States |
|
| UZ Leuven - PPDS | Recruiting | Leuven | 3000 | Belgium |
|
| ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII | Recruiting | Bergamo | Lombardy | 24127 | Italy |
|
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Active, not recruiting | Milan | Lombardy | 20133 | Italy |
| MICS Centrum Medyczne Bydgoszcz | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-065 | Poland |
|
| Krakowska Akademia Neurologii Sp. z o.o. | Recruiting | Krakow | Lesser Poland Voivodeship | 31-505 | Poland |
|
| Centrum Medyczne Neurologia Slaska | Recruiting | Katowice | Silesian Voivodeship | 40-689 | Poland |
|
| Hospital Regional Universitario de Malaga - Hospital General | Recruiting | Málaga | Malaga | 340120 | Spain |
|
| 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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