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| ID | Type | Description | Link |
|---|---|---|---|
| ALX-MG-502 | Other Identifier | Alexion |
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This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Corticosteroid Tapering Schedule | Experimental | During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Corticosteroid Tapering Schedule | Procedure | During the tapering period, participant will follow an Oral Corticosteroid tapering schedule as applicable to the participant. The oral corticosteroid (prednisone/prednisolone) is provided as per standard medical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG | Up to approximately 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG | Up to approximately 32 weeks | |
| Percentage Change From Daily OCS Dose (mg/day) at Baseline | Baseline, Up to approximately 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Chicago | Illinois | 60637 | United States | |
| Research Site |
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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| Ravulizumab | Drug | Patients being treated with intravenous ravulizumab as part of their standard medical care. |
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| Prednisone/Prednisolone | Drug | Participants will continue with or be switched to prednisone/prednisolone as per standard medical care. |
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| Change from Baseline in the Myasthenia Gravis Quality of Life-15 Revised (MG-QoL-15r) Score in Adult Participants with gMG | Baseline, Up to approximately 32 weeks |
| Change from Baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in Adult Participants with gMG | Baseline, Up to approximately 32 weeks |
| Cumulative Worsening Score per the Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD) in Adult Participants with gMG | Baseline up to approximately 32 weeks |
| Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG | Baseline up to approximately 32 weeks |
| Not yet recruiting |
| Schaumburg |
| Illinois |
| 60173 |
| United States |
| Research Site | Not yet recruiting | Neptune City | New Jersey | 07753 | United States |
| Research Site | Recruiting | Raleigh | North Carolina | 27607 | United States |
| Research Site | Not yet recruiting | Knoxville | Tennessee | 37920 | United States |
| Research Site | Not yet recruiting | Bochum | 44789 | Germany |
| Research Site | Not yet recruiting | Milan | 20122 | Italy |
| Research Site | Not yet recruiting | Naples | 80131 | Italy |
| Research Site | Not yet recruiting | Rome | 00189 | Italy |
| Research Site | Not yet recruiting | Ibaraki | 305-8576 | Japan |
| Research Site | Not yet recruiting | Kitakyushu-shi | 807-8555 | Japan |
| Research Site | Not yet recruiting | Kumamoto | 860-8556 | Japan |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D000309 | Adrenal Insufficiency |
| 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 |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000629409 | ravulizumab |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
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