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This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod PH20 SC | Experimental | Participants start efgartigimod PH20 SC treatment after discontinuing IVIg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod PH20 SC | Biological | Subcutaneous injection of efgartigimod PH20 SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in EQ-5D-5L scores over time | Up to 12 weeks | |
| Changes from baseline in TSQM-9 scores over time | Up to 12 weeks | |
| Changes from baseline in PGI-C scores over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Neurology Associates PA |
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| Up to 12 weeks |
| Changes from baseline in PGI-S scores over time | Up to 12 weeks |
| Incidence of (S)AEs | Up to 16 weeks |
| Maitland |
| Florida |
| 32751 |
| United States |
| Visionary Investigators Network | Miami | Florida | 33180 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Velocity Clinical Research | Lafayette | Louisiana | 70508 | United States |
| SRI International - ClinEdge | Plymouth | Michigan | 48170 | United States |
| Velocity Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Erlanger Neuroscience Institute | Chattanooga | Tennessee | 37403 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| National Neuromuscular Research Institute | Austin | Texas | 78759 | United States |
| Horizon Clinical Research: Gill Neuroscience | Cypress | Texas | 21216 | United States |
| Northwest Houston Neurology - Cypress | Cypress | Texas | 77429 | United States |
| Cedar Health Research - Dallas | Dallas | Texas | 75251 | United States |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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