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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520097-36-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).
More information can be found here: https://clinicaltrials.argenx.com/emvigorate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - empasiprubart + IVIg-placebo | Experimental | During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm. |
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| Part A - IVIg + empasiprubart-placebo | Active Comparator | During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm. |
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| Part B - empasiprubart | Experimental | After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empasiprubart | Biological | Intravenous infusion of empasiprubart |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of ≥1 point compared with baseline in aINCAT score at week 24 | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in I-RODS centile points score at week 24 | Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome). | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Samir Macwan, M.D., Inc. | Recruiting | Rancho Mirage | California | 922701 | United States |
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| Label | URL |
|---|---|
| Study website | View source |
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| IVIg | Biological | Intravenous infusion of IVIg |
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| empasiprubart-placebo | Other | A placebo resembling the empasiprubart treatment |
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| IVIg-placebo | Other | A placebo resembling the IVIg treatment |
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| Change from baseline in MRC-SS at week 24 |
The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome). |
| up to 24 weeks |
| Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24 | The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days. | up to 24 weeks |
| Time to reduction of ≥1 point from baseline in aINCAT score | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). | up to 24 weeks |
| Change from baseline in TUG at week 24 | The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured. | up to 24 weeks |
| Time to increase of ≥1 point compared with baseline in aINCAT score | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). | Up to 24 weeks |
| Change from baseline in grip strength (3-day moving average) of both hands over time | The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days. | up to 24 weeks + 96 weeks (Part B) |
| Change from baseline in grip strength (daily average) for both hands | The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand. | up to 24 weeks + 96 weeks (Part B) |
| Change from baseline in MRC-SS over time | The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome). | up to 96 weeks (Part B) |
| Change from baseline in aINCAT over time | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Change from baseline in EQ-5D-5L over time | EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome). | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Change from baseline in RT-FSS over time | Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression. | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Change from baseline in SF-12 over time | 12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure. | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Change from baseline in BPI-SF over time | The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference. | up to 24 weeks (Part A) + 96 weeks (Part B) |
| PGI-S values over time | The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness. | up to 24 weeks (Part A) + 96 weeks (Part B) |
| PGI-C values over time | The Patient Global Impression of Change (PGI-C) is a patient- reported outcome measure that reflects the patient's belief about the efficacy of treatment. | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Values for work-related and household chore activities of the HRPQ | The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'. | up to 24 weeks |
| Percentage of scheduled hours lost in total (absenteeism+ presenteeism) | up to 24 weeks |
| Change from baseline in I-RODS centile points score over time | Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome). | Up to 96 weeks (Part B) |
| Change from baseline in TUG over time | The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured. | Up to 96 weeks (Part B) |
| Incidence of antidrug antibodies against empasiprubart in serum | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Incidence of neutralizing antibodies against empasiprubart in serum | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Incidence of (serious) adverse events | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Percentage change from baseline in free C2 and total C2 over time | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Serum concentrations of empasiprubart over time | up to 24 weeks (Part A) + 96 weeks (Part B) |
| Colorado Springs Neurological Associates | Recruiting | Colorado Springs | Colorado | 80907 | United States |
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| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Homestead Associates in Research Inc | Recruiting | Homestead | Florida | 33033 | United States |
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| Visionary Investigators Network | Recruiting | Miami | Florida | 33133 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33616 | United States |
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| Paradigm Health System | Recruiting | Slidell | Louisiana | 70458 | United States |
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| Erlanger Health System | Recruiting | Columbia | Maryland | 21044 | United States |
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| University of Michigan Hospital | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| NeuroCarePlus | Recruiting | Houston | Texas | 77094 | United States |
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| National Neuromuscular Research Institute | Recruiting | Irving | Texas | 75063 | United States |
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| INECO Neurociencias Oroño | Recruiting | Rosario | S2000DTP | Argentina |
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| Universitätsklinikum AKH Wien | Recruiting | Vienna | 1090 | Austria |
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| Fakultni nemocnice Brno | Recruiting | Brno | Czechia |
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| Astra Kliinik | Recruiting | Tallinn | 11315 | Estonia |
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| Tartu University Hospital | Recruiting | Tartu | 50406 | Estonia |
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| AP-HP - Hôpital de la Pitié Salpétrière | Active, not recruiting | Paris | Paris | 75013 | France |
| CHU de Bordeaux - Hôpital Pellegrin | Recruiting | Bordeaux | 33076 | France |
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| AP-HP - Hôpital Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| CHU de Nice-Hôpital Pasteur | Recruiting | Nice | 6001 | France |
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| CHU de Strasbourg - Hôpital de Hautepierre | Recruiting | Strasbourg | 67200 | France |
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| CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan | Recruiting | Toulouse | 31059 | France |
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| Charité - Universitätsmedizin Berlin | Recruiting | Berlin | 13353 | Germany |
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| Universitätsklinikum Schleswig-Holstein - Campus Kiel | Recruiting | Kiel | 24105 | Germany |
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| University General Hospital of Alexandroupolis | Recruiting | Athens | 15562 | Greece |
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| University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA | Recruiting | Chaïdári | 124 62 | Greece |
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| The Barzilai University Medical Center | Recruiting | Ashkelon | 78278 | Israel |
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| Hadassah Medical Center- Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
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| The Chaim Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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| AUSL di Bologna - Ospedale Bellaria | Recruiting | Bologna | 40139 | Italy |
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| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Recruiting | Pavia | 27100 | Italy |
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| Azienda Ospedaliero-Universitaria Sant'Andrea | Recruiting | Roma | 00189 | Italy |
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| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Recruiting | Roma | 161 | Italy |
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| Aomori Prefectural Central Hospital | Recruiting | Aomori | 030-8553 | Japan |
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| Juntendo University Hospital | Recruiting | Bunkyō City | 113-8431 | Japan |
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| Chiba University Hospital | Recruiting | Chūōku | 260-8677 | Japan |
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| Juntendo Shizuoka University Hospital | Recruiting | Izunokuni | 410-2295 | Japan |
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| Osaka Metropolitan University Hospital | Recruiting | Osaka | 545-8586 | Japan |
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| Saga University Hospital | Recruiting | Saga | 849-8501 | Japan |
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| General Hospital Tsuchiura Kyodo Hospital | Recruiting | Tsuchiura | 300-0028 | Japan |
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| Yamaguchi University Hospital | Recruiting | Ube | 755-0067 | Japan |
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| Universitair Medisch Centrum Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
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| Oslo Universitetssykehus HF, Ullevål | Recruiting | Oslo | 450 | Norway |
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| MICS Centrum Medyczne Bydgoszcz | Recruiting | Bydgoszcz | 85-065 | Poland |
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| Neurocentrum Bydgoszcz | Recruiting | Bydgoszcz | 85-796 | Poland |
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| Centrum Medyczne Neurologia Slaska | Recruiting | Katowice | 40-689 | Poland |
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| SP ZOZ Szpital Uniwersytecki w Krakowie | Recruiting | Krakow | 30-688 | Poland |
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| Centrum Medyczne Linden | Recruiting | Krakow | 30-721 | Poland |
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| Galen Clinic - Lublin | Recruiting | Lublin | 20-064 | Poland |
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| Clinical Research Center Sp. z o.o. Medic-R sp.k. | Recruiting | Poznan | 61-731 | Poland |
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| Centrum Medyczne Medyk | Recruiting | Rzeszów | 35-210 | Poland |
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| Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie | Recruiting | Szczecin | 71-252 | Poland |
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| Uniwersytecki Szpital Kliniczny Nr 1 | Recruiting | Szczecin | 71-252 | Poland |
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| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Recruiting | Warsaw | 02-097 | Poland |
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| ULS de Santo António, EPE - Hospital de Santo António | Recruiting | Porto | 4050-342 | Portugal |
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| Institutul National de Neurologie si Boli Neurovasculare Bucuresti | Recruiting | Bucharest | 41914 | Romania |
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| Brainaxy Clinic SRL | Recruiting | Constanța | 900348 | Romania |
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| Targu-Mures Emergency Clinical County Hospital | Recruiting | Târgu Mureş | 540136 | Romania |
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| University Clinical Center of Serbia - Dr Subotica 6 | Recruiting | Belgrade | 11000 | Serbia |
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| University Clinical Center Nis | Recruiting | Niš | 18 000 | Serbia |
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| National Neuroscience Institute | Recruiting | Singapore | 308433 | Singapore |
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| Univerzitna nemocnica MARTIN | Recruiting | Martin | 036 59 | Slovakia |
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| University Medical Centre Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
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| University Clinical Centre Maribor | Recruiting | Maribor | 2000 | Slovenia |
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| Inje University Haeundae Paik Hospital | Recruiting | Busan | 48108 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Konkuk University Medical Center | Recruiting | Seoul | 05030 | South Korea |
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| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
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| Hospital Universitario Vall d'Hebron | Recruiting | Sant Andreu de la Barca | 08740 | Spain |
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| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| Sahlgrenska University Hospital | Recruiting | Gothenburg | 41346 | Sweden |
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| Hôpitaux Universitaires de Genève (HUG) | Recruiting | Geneva | 1205 | Switzerland |
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| Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi | Recruiting | Samsun | 55200 | Turkey (Türkiye) |
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| Salford Royal Hospital - PPDS | Active, not recruiting | Salford | Lancashire | M6 8HD | United Kingdom |
| 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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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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