11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details


臨床試験数 : 315 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT05265273
(ClinicalTrials.gov)
March 31, 202222/2/2022A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisAn Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisMyasthenia GravisDrug: NipocalimabJanssen Research & Development, LLCNULLNot yet recruiting2 Years17 YearsAll12Phase 2/Phase 3United States;Canada;Japan;Netherlands
2EUCTR2020-003272-41-DE
(EUCTR)
04/03/202204/01/2022A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Korea, Republic of
3EUCTR2020-005841-18-DE
(EUCTR)
09/02/202230/08/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2;Phase 3France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
4EUCTR2020-003272-41-ES
(EUCTR)
03/02/202228/09/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Korea, Republic of
5EUCTR2021-001229-26-ES
(EUCTR)
21/01/202214/12/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN2050
INN or Proposed INN: N/A
Other descriptive name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Korea, Democratic People's Republic of;Germany;Italy
6JPRN-jRCT2021210027
20/01/202213/08/2021A Study of Nipocalimab Administered to Adults with Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia GravisNipocalimab (JNJ-80202135, M281)
Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion from OLE Day 1 to 24 weeks. Participants who are stable on the q2w dosing regimen can be transitioned to a dosing regimen every 4 weeks (q4w) during OLE phase

Placebo
Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.
Nakano MasayoshiNULLPending>= 18age oldNot applicableBoth180Phase 3Belgium;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;Kingdom Of Great Britain And Northern Ireland;Italy;Mexico;Poland;Russian Federation;Sweden;Turkey;United States Of America;Japan
7EUCTR2021-002504-12-IT
(EUCTR)
19/01/202203/12/2021A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG) - ADAPT NXT Generalized Myasthenia Gravis (gMG)
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: [ARGX-113]
INN or Proposed INN: Efgartigimod
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 3France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
8EUCTR2020-005732-29-DK
(EUCTR)
13/01/202225/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
9EUCTR2021-003898-59-ES
(EUCTR)
12/01/202214/10/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Poland;Spain;Russian Federation;Germany;United Kingdom;Italy;Japan;China
10EUCTR2021-003898-59-PL
(EUCTR)
11/01/202225/11/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutinib
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China
11ChiCTR2100047506
2022-01-012021-06-20Efficacy of Buzhong Yiqi Decoction in the Treatment of Ocular Myopathy Myasthenia Gravis (MG) Patients with Spleen and Kidney Deficiency Type: a Randomized Controlled TrialEfficacy of Buzhong Yiqi Decoction in the Treatment of Ocular Myopathy Myasthenia Gravis (MG) Patients with Spleen and Kidney Deficiency Type: a Randomized Controlled Trial Ocular myasthenia gravisExperimental group:Buzhong Yiqi Decoction;contrast group:Pyridostigmine Bromide Tablets;Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji’nan UniversityNULLRecruiting1880BothExperimental group:27;contrast group:27;China
12NCT04982289
(ClinicalTrials.gov)
January 1, 202221/6/2021Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia GravisA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: ALXN1830;Other: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
13NCT05218096
(ClinicalTrials.gov)
December 30, 202116/12/2021Study of ALXN2050 in Adult Participants With Generalized Myasthenia GravisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia GravisGeneralized Myasthenia Gravis;Myasthenia GravisDrug: ALXN2050;Drug: PlaceboAlexion PharmaceuticalsNULLRecruiting18 YearsN/AAll70Phase 2United States
14EUCTR2021-001229-26-IT
(EUCTR)
21/12/202119/10/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants withGeneralized Myasthenia Gravis - - Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Menveo
Product Name: Menveo
Product Code: [N/A]
INN or Proposed INN: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
INN or Proposed INN: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 ADSORBED ON ALUMINUM HYDROXIDE
Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO
INN or Proposed INN: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
INN or Proposed INN: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN
Trade Name: Velamox
Product Name: Velamox
Product Code: [N/A]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Germany;Italy;Korea, Republic of
15NCT04980495
(ClinicalTrials.gov)
December 16, 202119/7/2021An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia GravisA Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: Efgartigimod concentrate for solution for infusion 20 mg/mLargenxNULLRecruiting18 YearsN/AAll72Phase 3United States;Georgia;Poland;Spain
16EUCTR2020-003272-41-IT
(EUCTR)
13/12/202119/10/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis - Study of Pozelimab and Cemdisiran combination therapy in patients with Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cemdisiran
Product Code: [ALN-CC5]
INN or Proposed INN: Cemdisiran
Product Name: Pozelimab
Product Code: [REGN3918]
INN or Proposed INN: Pozelimab
Trade Name: Bexsero
Product Name: Bexsero
Product Code: [NA]
INN or Proposed INN: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254measured as amount of total protein containing the PorA P1.4
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E.COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
INN or Proposed INN: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
INN or Proposed INN: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN
Other descriptive name: RECOMBINANT NEISSERIA
REGENERON PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Korea, Republic of
17NCT05132569
(ClinicalTrials.gov)
December 3, 202112/11/2021Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia GravisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG)Myasthenia GravisDrug: Tolebrutininb;Drug: PlaceboSanofiNULLRecruiting18 Years85 YearsAll154Phase 3United States;Hungary;United Kingdom
18EUCTR2020-003272-41-PL
(EUCTR)
01/12/202121/10/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Korea, Republic of
19NCT05067348
(ClinicalTrials.gov)
November 30, 202123/9/2021Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: Tocilizumab Injectable ProductTang-Du HospitalNULLNot yet recruiting18 Years80 YearsAll64Phase 2China
20EUCTR2021-003898-59-HU
(EUCTR)
30/11/202104/12/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - URSA Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China
21EUCTR2020-005841-18-IT
(EUCTR)
29/11/202125/08/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: [argx-113]
INN or Proposed INN: EFGARTIGIMOD ALFA
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2;Phase 3France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
22EUCTR2021-002504-12-ES
(EUCTR)
26/11/202102/12/2021An open-label study to investigate the clinical efficacy of different dosing regimens of efgartigimod IV in patients with generalized myasthenia gravisA Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG) - ADAPT NXT Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 3France;United States;Canada;Poland;Belgium;Spain;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
23EUCTR2020-005732-29-DE
(EUCTR)
19/11/202123/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
24EUCTR2021-003898-59-IT
(EUCTR)
12/11/202106/10/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - . Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: [SAR442168]
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;China;Italy
25EUCTR2020-005732-29-SE
(EUCTR)
03/11/202124/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
26JPRN-jRCT2021210024
02/11/202130/07/2021A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVISA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Myasthenia GravisSatralizumab: 120 mg or 180mg SC injection every 4 weeks (Q4W)Ivana VodopivecNULLRecruiting>= 12age oldNot applicableBoth240Phase 3Brazil;Canada;United States;Argentina;Australia;China;Denmark;France;Germany;Italy;Republic of Korea;Netherlands;Poland;Russian Federation;Spain;Taiwan;Turkey;Japan
27EUCTR2020-004436-21-DE
(EUCTR)
02/11/202116/03/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
28NCT04833894
(ClinicalTrials.gov)
October 26, 202116/3/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: Efgartigimod IVargenxNULLRecruiting2 Years18 YearsAll12Phase 2/Phase 3Belgium;France;Georgia;Poland;Spain
29EUCTR2020-005732-29-CZ
(EUCTR)
21/10/202115/07/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
30NCT04963270
(ClinicalTrials.gov)
October 19, 20217/7/2021A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia GravisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Satralizumab;Other: PlaceboHoffmann-La RocheNULLRecruiting12 YearsN/AAll240Phase 3United States;Argentina;China;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Taiwan;Turkey;Australia;Brazil;Canada
31EUCTR2020-005841-18-ES
(EUCTR)
05/10/202106/10/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2;Phase 3France;United States;Canada;Poland;Belgium;Spain;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
32NCT04965987
(ClinicalTrials.gov)
October 202110/6/2021Oxaloacetate in Myasthenia GravisA Phase I, Double-Blind, Pilot Study of Oxaloacetate in Myasthenia GravisMyasthenia GravisDrug: Oxaloacetate;Drug: PlaceboUniversity of Kansas Medical CenterTerra Biological LLCNot yet recruiting18 YearsN/AAll12Phase 1United States
33NCT05070858
(ClinicalTrials.gov)
September 30, 202127/9/2021A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Symptomatic Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Pozelimab (REGN3918) + Cemdisiran;Drug: Cemdisiran;Other: PlaceboRegeneron PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll210Phase 3NULL
34EUCTR2020-005841-18-BE
(EUCTR)
29/09/202121/06/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2;Phase 3France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
35NCT05039190
(ClinicalTrials.gov)
September 10, 202129/8/2021A Study to Evaluate Thefficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized MG PatientsA Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: HBM9161 Injection (680mg);Drug: PlacebosHarbour BioMed (Guangzhou) Co. Ltd.NULLNot yet recruiting18 Years99 YearsAll144Phase 3China
36EUCTR2020-005732-29-ES
(EUCTR)
03/09/202126/08/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
37EUCTR2020-005732-29-IT
(EUCTR)
20/08/202112/10/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis - N/A Myasthenia gravis (MG);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Nipocalimab
Product Code: [JNJ-80202135]
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
38JPRN-jRCT2021210003
18/08/202121/04/2021Myasthenia Gravis Inebilizumab TrialA Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis - VIB0551.P3.S1 AChR-Ab+ or MuSK-Ab+ generalized Myasthenia Gravis(RCP: Randomized Controlled Period)
Treatment group 1: AChR-Ab positive population (active) - inebilizumab 300 mg administered intravenously (IV) on Days 1, 15, and 183 of the RCP
Treatment group 2: AChR-Ab positive population (placebo) - IV placebo on Days 1, 15, and 183 of the RCP
Treatment group 3: MuSK-Ab positive population (active) - inebilizumab 300 mg IV on Days 1 and 15 of the 26-week RCP
Treatment group 4: MuSK-Ab positive population (placebo) - IV placebo on Days 1 and 15 of the 26-week RCP
Katayama SotaNULLRecruiting>= 18age oldNot applicableBoth16Phase 3USA;Ukraine;China;Argentina;Brazil;Canada;France;Denmark;Germany;Israel;India;Italy;Poland;Spain;Belarus;Russia;Taiwan;Turkey;South Korea;Japan
39EUCTR2020-004436-21-DK
(EUCTR)
11/08/202111/03/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
Product Name: Satralizumab
Product Code: Ro 533-3787/F01-06
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of
40EUCTR2020-004086-38-DE
(EUCTR)
06/08/202112/02/2021Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
201Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
41EUCTR2020-004436-21-NL
(EUCTR)
05/08/202106/04/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
Product Name: Satralizumab
Product Code: Ro 533-3787/F01-06
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
42EUCTR2020-000949-14-DE
(EUCTR)
30/07/202108/12/2020Inebilizumab efficacy and safety in adults with myasthenia gravisA RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of
43EUCTR2020-005762-34-PL
(EUCTR)
15/07/202104/03/2021Cladribine therapy in MyastheniaA phase 2 clinical trial assessing the efficacy and safety of adding cladribine for treatment modifying course of seropositive myasthenia gravis Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cladrybine
INN or Proposed INN: CLADRIBINE
Medical University of LublinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Poland
44NCT04951622
(ClinicalTrials.gov)
July 15, 202130/6/2021A Study of Nipocalimab Administered to Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia GravisMyasthenia GravisDrug: Nipocalimab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll180Phase 3United States;Australia;Belgium;Canada;China;Colombia;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Sweden;Taiwan;Turkey;United Kingdom
45EUCTR2019-001565-33-PL
(EUCTR)
07/07/202119/04/2021Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc. (now part of UCB)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Poland;Norway;Germany;United Kingdom;Italy;Japan;Korea, Republic of
46EUCTR2020-004436-21-ES
(EUCTR)
17/06/202102/09/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
47EUCTR2020-005619-35-IT
(EUCTR)
07/06/202102/08/2021SINGLE-CELL DEEP PHENOTYPING OF B LYMPHOCYTES TO PERSONALIZE IMMUNOTHERAPY IN PATIENTS WITH MYASTHENIA GRAVIS: CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RITXUXIMAB IN GENERALIZED ACHR-ANTIBODY POSITIVE MYASTHENIA GRAVISSINGLE-CELL DEEP PHENOTYPING OF B LYMPHOCYTES TO PERSONALIZE IMMUNOTHERAPY IN PATIENTS WITH MYASTHENIA GRAVIS: CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RITXUXIMAB IN GENERALIZED ACHR-ANTIBODY POSITIVE MYASTHENIA GRAVIS - REFINE 2020 Generalized AChR-antibody positive Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: rituximab
Product Code: [rituximab]
INN or Proposed INN: rituximab
Other descriptive name: rituximab
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Italy
48EUCTR2020-004086-38-NL
(EUCTR)
02/06/202112/04/2021Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
201Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina
49EUCTR2020-004085-19-DE
(EUCTR)
31/05/202129/01/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
50EUCTR2020-004436-21-IT
(EUCTR)
21/05/202108/06/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS - - Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: [RO5333787]
INN or Proposed INN: SATRALIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
51EUCTR2020-004086-38-ES
(EUCTR)
07/05/202101/09/2021Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
201Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
52EUCTR2020-004086-38-BE
(EUCTR)
04/05/202104/03/2021Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
201Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
53EUCTR2020-004086-38-IT
(EUCTR)
27/04/202108/06/2021Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
Product Code: [.]
INN or Proposed INN: EFGARTIGIMOD ALFA
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
201Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
54EUCTR2020-004085-19-IT
(EUCTR)
26/04/202107/06/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
Product Code: [NA]
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
Product Code: [NA]
INN or Proposed INN: EFGARTIGIMOD ALFA
ARGENX BVNULLNot RecruitingFemale: yes
Male: yes
76Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
55NCT04818671
(ClinicalTrials.gov)
April 26, 202111/3/2021Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: efgartigimod PH20 SCargenxNULLRecruiting18 YearsN/AAll201Phase 3United States;Belgium;Czechia;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain
56EUCTR2020-004086-38-HU
(EUCTR)
22/04/202118/02/2021Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisA Long-term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
201Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
57EUCTR2016-001384-37-NL
(EUCTR)
13/04/202114/12/2020An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG) Refractory Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 3United States;Canada;Germany;Netherlands;Japan
58NCT04226170
(ClinicalTrials.gov)
April 8, 20219/1/2020Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia GravisA Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia GravisMyasthenia GravisDrug: DAS-001DAS-MG, IncNULLRecruiting18 YearsN/AAll24Phase 2United States
59NCT04777734
(ClinicalTrials.gov)
April 202126/2/2021Efgartigimod Expanded Access for Generalized Myasthenia GravisAn Expanded Access Program for Efgartigimod Treatment in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: efgartigimodargenxNULLAvailable18 YearsN/AAllNULL
60EUCTR2020-004085-19-NL
(EUCTR)
19/03/202105/01/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNot RecruitingFemale: yes
Male: yes
76Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina
61EUCTR2020-004085-19-BE
(EUCTR)
16/03/202112/01/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3Georgia;Germany;Netherlands;Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Japan;Bosnia and Herzegovina
62JPRN-UMIN000044102
2021/03/0504/05/2021Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravisEffect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis - Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis myasthenia gravisStudy group A (n=15) underwent the partial weight support for 30 min. and designed physical therapy program (balance strategy exercises and breathing exercise) for 30 min.
3 times/week for three successive months
control group B (n= 15) underwent the designed physical therapy program.
3 times/week for three successive months
individualizedNULLComplete: follow-up complete12years-old15years-oldMale and Female30Not selectedAfrica
63EUCTR2020-000949-14-DK
(EUCTR)
24/02/202124/11/2020Inebilizumab efficacy and safety in adults with myasthenia gravisA RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of
64EUCTR2020-004085-19-HU
(EUCTR)
24/02/202129/12/2020Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
65ChiCTR2100043273
2021-02-202021-02-09Efficacy and safety of tocilizumab in the treatment of generalizaed myasthenia gravis: a single-center, prospective cohort studyEfficacy and safety of tocilizumab in the treatment of generalizaed myasthenia gravis: a single-center, prospective cohort study Myasthenia gravisTocilizumab treatment group:Tocilizumab+Oral corticosteroids;Conventional immunotherapy group:Oral immunosuppressant;Department of Neurology, The Second Affiliated Hospital of Air Force Medical UniversityNULLRecruiting1880BothTocilizumab treatment group:32;Conventional immunotherapy group:32;N/AChina
66JPRN-jRCTs051200137
17/02/202117/02/2021Efficacy and safety of methylprednisolone pulse therapy for ocular myasthenia gravis: a pilot studyEfficacy and safety of methylprednisolone pulse therapy for ocular myasthenia gravis: a pilot study - ESPRETHO ocular myasthenia gravis
ocular myasthenia gravis, steroid pulse, methylprednisolone
Methylprednisolone 1 g daily is administered intravenously for 3 consecutive days for 2 to 3 courses, and then 5 mg of prednisolone daily is orally administered until 16 weeks.Koh JinsooNULLRecruiting>= 20age oldNot applicableBoth10N/AJapan
67JPRN-jRCT2021200038
09/02/202109/02/2021A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis - MG0007 Generalized Myasthenia GravisRozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.SUGIHARA KazuhiroNULLRecruiting>= 18age oldNot applicableBoth18Phase 3Belgium;Canada;Czech Republic,;Denmark;France;Georgia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Taiwan;UK;US;Japan
68NCT04735432
(ClinicalTrials.gov)
February 5, 202126/1/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: efgartigimod PH20 SC;Biological: efgartigimod IVargenxNULLCompleted18 YearsN/AAll111Phase 3United States;Belgium;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain
69NCT04650854
(ClinicalTrials.gov)
February 3, 20215/11/2020A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia GravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: RozanolixizumabUCB Biopharma SRLNULLActive, not recruiting18 YearsN/AAll165Phase 3United States;Canada;Czechia;Denmark;France;Georgia;Germany;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;Hungary
70EUCTR2020-003230-20-BE
(EUCTR)
11/01/202107/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
71NCT04768465
(ClinicalTrials.gov)
January 1, 202121/2/2021Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia GravisEffectiveness and Safety of Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis: A Real-world StudyMyasthenia GravisDrug: Pyridostigmine, Prednisone, Tacrolimus;Drug: Pyridostigmine, TacrolimusDa, Yuwei, M.D.NULLRecruiting18 YearsN/AAll160China
72NCT05091177
(ClinicalTrials.gov)
January 1, 20219/10/2021Study on Correlation Between Cytomegalovirus and Ocular Myasthenia GravisStudy on Correlation Between Cytomegalovirus and Ocular Myasthenia GravisOcular Myasthenia Gravis;Cytomegalovirus InfectionsDiagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulationXiaoYong LiuNULLRecruiting18 Years50 YearsAll125China
73EUCTR2020-003230-20-IT
(EUCTR)
15/12/202030/08/2021A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis - - Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
74EUCTR2020-003230-20-PL
(EUCTR)
14/12/202030/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
75EUCTR2020-003230-20-DE
(EUCTR)
02/12/202014/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
76EUCTR2020-003230-20-HU
(EUCTR)
01/12/202001/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
77EUCTR2020-003230-20-GB
(EUCTR)
30/11/202002/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
78EUCTR2020-003230-20-DK
(EUCTR)
17/11/202006/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
79EUCTR2020-000949-14-FR
(EUCTR)
16/11/202008/10/2020Inebilizumab efficacy and safety in adults with myasthenia gravisA RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 3Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China
80EUCTR2016-001384-37-DE
(EUCTR)
07/10/202017/12/2018An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG) Refractory Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
17Phase 3United States;Canada;Netherlands;Germany;Japan
81NCT04524273
(ClinicalTrials.gov)
August 30, 202010/8/2020Myasthenia Gravis Inebilizumab TrialA Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia GravisMyasthenia GravisDrug: inebilizumab;Drug: IV PlaceboViela BioNULLRecruiting18 YearsN/AAll270Phase 3United States;Argentina;Belarus;Brazil;Canada;China;Denmark;France;Germany;India;Israel;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Ukraine
82NCT04728425
(ClinicalTrials.gov)
August 28, 202014/7/2020Subcutaneous Immunoglobulin for Myasthenia GravisEfficacy and Safety of Subcutaneous Immunoglobulin in Patients With Myasthenia GravisMyasthenia GravisDrug: subcutaneous immunoglobulin (SCIG);Drug: intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)University Health Network, TorontoNULLRecruiting18 Years100 YearsAll30Phase 2Canada
83EUCTR2019-003383-47-IT
(EUCTR)
12/08/202025/09/2020A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia GravisA Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - - Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TAK-079
Product Code: [TAK-079, TSF-021, TSF79]
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Product Name: metilprdnisolone
Product Code: [-]
INN or Proposed INN: METILPREDNISOLONE
Other descriptive name: methylprednisolone
Product Name: difenidramina
Product Code: [NA]
INN or Proposed INN: DIFENIDRAMINA CLORIDRATO
Other descriptive name: diphenhydramine hydrochloride
Product Name: paracetamolo
Product Code: [acetominofene]
INN or Proposed INN: PARACETAMOLO
Other descriptive name: acetaminophen
MILLENNIUM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Serbia;Canada;Spain;Poland;Italy
84NCT04302103
(ClinicalTrials.gov)
July 23, 20206/3/2020A Study of TACI(Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor)-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia GravisA Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Systemic Myasthenia GravisSystemic Myasthenia GravisBiological: RC18 160mg;Biological: RC18 240 mgRemeGen Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll29Phase 2China
85NCT04346888
(ClinicalTrials.gov)
July 23, 202013/4/2020A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: HBM9161 Injection (680mg and 340 mg);Drug: Placebos;Drug: HBM9161 Injection (340 mg)Harbour BioMed (Guangzhou) Co. Ltd.NULLCompleted18 Years99 YearsAll30Phase 2China
86JPRN-JapicCTI-205350
20/7/202001/07/2020A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Generalized myasthenia gravisIntervention name : Rozanolixizumab
INN of the intervention : rozanolixizumab
Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages
(dose 1 and dose 2) in dosage regimen 1 and 2.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., Ltd.NULLrecruiting18BOTH18Phase 3Japan, Asia except Japan, North America, Europe
87EUCTR2018-003243-39-PT
(EUCTR)
15/06/202006/02/2020Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of
88NCT04431895
(ClinicalTrials.gov)
June 11, 202012/6/2020Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot StudyA Prospective,Single-center,Single-Arm,Single-Blind Pilot Study To Investigate The Efficacy Of Tofacitinib In Patients With Refractory Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: Tofacitinib 5 MGHuashan HospitalNULLRecruiting18 Years60 YearsAll20Early Phase 1China
89NCT05045248
(ClinicalTrials.gov)
June 1, 202029/8/2021Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia GravisEfficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia GravisMyasthenia Gravis;Ocular Myasthenia GravisDrug: Apraclonidine Hcl 0.5% Oph SolnAmerican University of Beirut Medical CenterNULLCompleted18 YearsN/AAll10Phase 2Lebanon
90EUCTR2019-001565-33-ES
(EUCTR)
13/05/202014/01/2020Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;France;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy
91EUCTR2019-001564-30-ES
(EUCTR)
13/05/202011/11/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United Kingdom;Japan;Italy;United States;France;Canada;Spain;Norway;Germany
92EUCTR2019-000969-21-DE
(EUCTR)
20/04/202005/11/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
93EUCTR2019-000969-21-PL
(EUCTR)
12/04/202020/02/2020A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
94EUCTR2019-001564-30-DE
(EUCTR)
31/03/202001/10/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 3France;United States;Canada;Spain;Poland;Norway;Germany;United Kingdom;Italy;Japan;Korea, Republic of
95JPRN-JapicCTI-205207
11/3/202004/03/2020A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Generalized myasthenia gravisIntervention name : Rozanolixizumab
INN of the intervention : rozanolixizumab
Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages
(dose 1 and dose 2) in dosage regimen 1 and 2.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., Ltd.NULLpending18BOTH18Phase 3Japan, Asia except Japan, North America, Europe
96EUCTR2019-000969-21-CZ
(EUCTR)
24/02/202020/12/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
97EUCTR2019-000969-21-ES
(EUCTR)
14/02/202011/11/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
98EUCTR2018-003243-39-GB
(EUCTR)
11/02/202008/10/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
99NCT04159805
(ClinicalTrials.gov)
January 20, 20208/11/2019A Study of TAK-079 in People With Generalized Myasthenia GravisA Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: TAK-079;Drug: TAK-079 PlaceboTakedaNULLRecruiting18 YearsN/AAll36Phase 2United States;Canada;Italy;Poland;Serbia;Spain
100EUCTR2019-000969-21-IT
(EUCTR)
15/01/202027/01/2021A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients WithGeneralized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 3United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
101EUCTR2019-001564-30-IT
(EUCTR)
10/01/202007/01/2021A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
Product Code: [na]
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy
102EUCTR2019-001565-33-IT
(EUCTR)
10/01/202007/01/2021Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
Product Code: [na]
INN or Proposed INN: zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy
103EUCTR2019-000969-21-GB
(EUCTR)
06/01/202015/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 3Germany;Denmark;Poland;Belgium;Canada;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Spain;United States
104EUCTR2018-003243-39-CZ
(EUCTR)
02/01/202013/09/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
105NCT04225871
(ClinicalTrials.gov)
December 23, 20192/10/2019Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495)Ra PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll200Phase 3United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom
106EUCTR2019-000968-18-PL
(EUCTR)
19/12/201909/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
107EUCTR2019-000969-21-HU
(EUCTR)
04/12/201915/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
108NCT04146051
(ClinicalTrials.gov)
December 4, 201929/10/2019Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG)Myasthenia Gravis, GeneralizedDrug: Descartes-08Cartesian TherapeuticsNULLRecruiting18 YearsN/AAll18Phase 1/Phase 2United States
109EUCTR2019-000968-18-DE
(EUCTR)
15/11/201910/07/2019A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
110EUCTR2019-000968-18-GB
(EUCTR)
14/11/201928/06/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Taiwan;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;United States;Hong Kong;Spain;Russian Federation;United Kingdom
111EUCTR2019-000968-18-CZ
(EUCTR)
11/11/201913/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
112EUCTR2019-000969-21-DK
(EUCTR)
07/11/201917/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
113NCT04182984
(ClinicalTrials.gov)
November 4, 201926/11/2019TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world StudyTheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world StudyOcular Myasthenia GravisDrug: Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil)Tang-Du HospitalNULLRecruiting18 Years75 YearsAll200China
114EUCTR2019-001565-33-GB
(EUCTR)
30/10/201901/11/2019Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom
115EUCTR2019-001564-30-GB
(EUCTR)
29/10/201901/11/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom
116NCT04124965
(ClinicalTrials.gov)
October 29, 201911/10/2019A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: RozanolixizumabUCB Biopharma SRLNULLCompleted18 YearsN/AAll71Phase 3United States;Canada;Czechia;Denmark;France;Germany;Italy;Japan;Poland;Russian Federation;Spain;Taiwan
117EUCTR2019-000968-18-BE
(EUCTR)
14/10/201914/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
118EUCTR2018-003243-39-AT
(EUCTR)
09/10/201926/04/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of
119EUCTR2019-000968-18-HU
(EUCTR)
25/09/201923/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
120EUCTR2019-000968-18-IT
(EUCTR)
25/09/201927/01/2021A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
121EUCTR2018-003243-39-DK
(EUCTR)
20/09/201922/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of
122NCT04115293
(ClinicalTrials.gov)
September 17, 20192/10/2019Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNULLCompleted18 Years74 YearsAll174Phase 3United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom
123EUCTR2019-000968-18-DK
(EUCTR)
06/09/201924/06/2019A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
124EUCTR2019-000968-18-ES
(EUCTR)
28/08/201912/09/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
125NCT03896295
(ClinicalTrials.gov)
August 6, 201928/3/2019An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia GravisAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: M281Momenta Pharmaceuticals, Inc.NULLTerminated18 YearsN/AAll37Phase 2United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
126EUCTR2018-003618-41-BE
(EUCTR)
05/08/201905/04/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis Generalized Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
127ChiCTR1900024644
2019-07-302019-07-19Investigation of the clinical heterogeneity of childhood onset myasthenia gravis in ChinaInvestigation of mechanism of clinical heterogeneity of childhood onset myasthenia gravis and precision therapeutic strategies in China maysthenia gravisroutine group:routine therapy;FK506 group:routine+FK506 therapy;RTX group:routine+RTX therapy;Thymectomy group:routine+Thymectomy therapy;FK506+Thymectomy group:routine+FK506+Thymectomy therapy;RTX+Thymectomy group:routine+RTX+Thymectomy therapy;Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNULLPendingBothroutine group:20;FK506 group:20;RTX group:20;Thymectomy group:20;FK506+Thymectomy group:20;RTX+Thymectomy group:20;N/AChina
128EUCTR2018-003243-39-DE
(EUCTR)
30/07/201925/03/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Trade Name: Ultomiris 1,100 mg/11 mL
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of
129EUCTR2018-003243-39-NL
(EUCTR)
22/07/201901/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
130EUCTR2018-003618-41-PL
(EUCTR)
05/07/201913/05/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis Generalized Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
131EUCTR2018-003618-41-DE
(EUCTR)
01/07/201929/03/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis Generalized Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
132EUCTR2018-003243-39-IT
(EUCTR)
17/06/201922/01/2021Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - NA Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
133EUCTR2018-002133-37-NL
(EUCTR)
06/06/201926/09/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Netherlands;Germany;Japan;Sweden
134EUCTR2018-003618-41-GB
(EUCTR)
05/06/201928/03/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis Generalized Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
135NCT03971422
(ClinicalTrials.gov)
June 3, 201929/5/2019A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Rozanolixizumab;Other: PlaceboUCB Biopharma SRLNULLCompleted18 YearsN/AAll200Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;United Kingdom
136EUCTR2018-003243-39-ES
(EUCTR)
21/05/201927/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Spain;Denmark;Austria;Israel;Netherlands;Germany;Japan;Italy;Switzerland;Korea, Republic of
137NCT03863080
(ClinicalTrials.gov)
May 21, 201920/2/2019A Study of RVT-1401 in Myasthenia Gravis (MG) PatientsA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis PatientsMyasthenia GravisDrug: RVT-1401;Drug: PlaceboImmunovant Sciences GmbHNULLCompleted18 YearsN/AAll17Phase 2United States;Canada
138EUCTR2018-003618-41-IT
(EUCTR)
09/05/201924/05/2021To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis - --- Generalized Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
Product Code: [M281]
MOMENTA PHARMACEUTICALS, IncNULLNot RecruitingFemale: yes
Male: yes
54Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
139EUCTR2018-002132-25-NL
(EUCTR)
30/04/201926/09/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Sweden
140NCT03772587
(ClinicalTrials.gov)
April 10, 201910/12/2018A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia GravisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: M281;Other: PlaceboMomenta Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll68Phase 2United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
141EUCTR2018-003618-41-ES
(EUCTR)
02/04/201912/04/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis Generalized Myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 2United States;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy
142NCT03914638
(ClinicalTrials.gov)
April 1, 201911/4/2019Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia GravisBeta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia GravisMyasthenia GravisDrug: Salbutamol 4Mg Tablet;Drug: Placebo oral capsuleUniversity of AarhusNULLRecruiting18 YearsN/AAll30Phase 2/Phase 3Denmark
143EUCTR2019-000895-40-DK
(EUCTR)
28/03/201926/02/2019Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia GravisBeta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis - BETA-MG Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Salbutamol WZF 4 mg
INN or Proposed INN: Salbutamol
Other descriptive name: SALBUTAMOL SULFATE PH. EUR.
Aarhus University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Denmark
144NCT03920293
(ClinicalTrials.gov)
March 26, 201916/4/2019Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia GravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: Ravulizumab;Drug: PlaceboAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll175Phase 3United States;Austria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Spain;Switzerland
145EUCTR2018-002247-28-BE
(EUCTR)
18/03/201905/12/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom
146NCT03770403
(ClinicalTrials.gov)
March 1, 201916/11/2018A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle WeaknessGeneralized Myasthenia GravisBiological: ARGX-113argenxNULLActive, not recruiting18 YearsN/AAll151Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia
147EUCTR2018-002247-28-PL
(EUCTR)
27/02/201931/12/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
148EUCTR2018-002133-37-DK
(EUCTR)
26/02/201913/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
149EUCTR2018-002132-25-CZ
(EUCTR)
25/02/201901/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
150EUCTR2018-002133-37-CZ
(EUCTR)
25/02/201902/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Netherlands;Germany;Japan
151EUCTR2018-002132-25-DE
(EUCTR)
22/02/201912/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
152EUCTR2018-002133-37-DE
(EUCTR)
22/02/201912/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan
153EUCTR2018-002247-28-GB
(EUCTR)
05/02/201930/11/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
154EUCTR2018-002247-28-IT
(EUCTR)
04/02/201904/11/2020To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: [M281]
INN or Proposed INN: M281
MOMENTA PHARMACEUTICALS, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
155EUCTR2018-002132-25-HU
(EUCTR)
28/01/201916/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Sweden
156EUCTR2018-002133-37-HU
(EUCTR)
28/01/201922/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
157EUCTR2018-002133-37-BE
(EUCTR)
21/01/201919/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan
158EUCTR2018-002132-25-BE
(EUCTR)
21/01/201916/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
159EUCTR2018-002132-25-FR
(EUCTR)
15/01/201929/10/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden
160NCT03759366
(ClinicalTrials.gov)
December 21, 201826/11/2018A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia GravisMyasthenia Gravis;Myasthenia Gravis, Juvenile Form;Myasthenia Gravis, GeneralizedDrug: EculizumabAlexion PharmaceuticalsNULLActive, not recruiting6 Years17 YearsAll11Phase 3United States;Japan;Netherlands
161EUCTR2018-002247-28-ES
(EUCTR)
14/12/201818/01/2019To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy
162EUCTR2018-002132-25-DK
(EUCTR)
13/12/201828/09/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
163EUCTR2018-002132-25-IT
(EUCTR)
27/11/201812/02/2021An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness. - NA Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: [ARGX-113]
INN or Proposed INN: Efgartigimod
ARGEN-X BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
164EUCTR2018-002133-37-IT
(EUCTR)
27/11/201822/01/2021A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness - NA Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: [ARGX-113]
INN or Proposed INN: Efgartigimod
ARGEN-X BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden
165ChiCTR1800017564
2018-09-082018-08-04Optimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Follow-up Prospective StudyOptimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Prospective Study Myasthenia GravisExperiment group versus Control group:Thymectomy plus oral prednisone, an immunosuppressant protocol versus Prednisone, or immunosuppressants alone;The First Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineNULLPending180BothExperiment group versus Control group:822;China
166NCT03669588
(ClinicalTrials.gov)
September 5, 20186/9/2018An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle WeaknessGeneralized Myasthenia GravisBiological: ARGX-113;Biological: PlaceboargenxNULLCompleted18 YearsN/AAll167Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom
167NCT03579966
(ClinicalTrials.gov)
July 1, 20185/6/2018Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia GravisMyasthenia Gravis, MuSKDrug: Amifampridine PhosphateCatalyst Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll70Phase 3United States
168NCT03165435
(ClinicalTrials.gov)
July 201817/5/2017A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia GravisA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Active Targeted Immunotherapy CV-MG01 in Patients With Moderate to Severe Myasthenia Gravis.Myasthenia Gravis, GeneralizedBiological: CV-MG01;Biological: PlaceboCuraVacAepodia;University Hospital, AntwerpWithdrawn18 YearsN/AAll0Phase 2/Phase 3Belgium;Netherlands
169EUCTR2017-004777-14-IT
(EUCTR)
05/06/201821/01/2021Clinical study evaluating the long term safety of amifampridine phosphate in patients with MuSK antibody and AChR antibody positive myasthenia gravisLong term safety study of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis patients - MSK-003 MuSK antibody and AChR antibody positive myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
CATALYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Canada;Italy
170NCT03490539
(ClinicalTrials.gov)
May 7, 201821/3/2018Disease-Modifying Treatments for Myasthenia GravisProspective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-modifying Treatments for Myasthenia GravisNeurological Disorder;Autoimmune DiseasesDrug: Mycophenolate Mofetil;Drug: AzathioprineDuke UniversityBeth Israel Deaconess Medical Center;Patient-Centered Outcomes Research InstituteCompleted18 YearsN/AAll167United States;Canada
171NCT03510546
(ClinicalTrials.gov)
April 9, 20186/4/2018Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia GravisEffect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia GravisMyasthenia GravisDrug: Pyridostigmine;Drug: Placebo oral capsuleUniversity of AarhusAarhus University HospitalRecruiting18 Years90 YearsAll44Phase 4Denmark
172NCT03304054
(ClinicalTrials.gov)
March 7, 201828/9/2017Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MGA Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis PatientsMyasthenia Gravis, GeneralizedDrug: Amifampridine Phosphate;Drug: Placebo Oral TabletCatalyst Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll70Phase 3United States
173EUCTR2017-004018-25-IT
(EUCTR)
22/02/201819/01/2021Clinical study evaluating the effect of Amifampridine phosphate in patients with MuSK antibody positive myasthenia gravis, and a sample of AchR antibody positive myasthenia gravis patients A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients - MSK-002 MuSK antibody positive myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
CATALYST PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Canada;Italy
174ChiCTR1900024692
2018-01-012019-07-22Comparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modificationComparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modification Myasthenia Graviseye muscles type:bromopyramine + hormone;eye muscles type:bromopyramine + hormone + azathioprine;eye muscles type:bromopyramine + hormone + cyclosporine;non-eye muscle type:bromopyramine + hormone + azathioprine;non-eye muscle type :bromopyramine + hormone + cyclosporine;Neurology Department of the 940th Hospital of Joint Logistics Support force of Chinese People's Liberation ArmyNULLRecruiting380Botheye muscles type:20;eye muscles type:20;eye muscles type:20;non-eye muscle type:20;non-eye muscle type :20;N/AChina
175EUCTR2017-002599-15-DK
(EUCTR)
07/11/201707/07/2017Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis.Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis. Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Mestinon
INN or Proposed INN: pyridostigmine
Other descriptive name: PYRIDOSTIGMINE
Aarhus UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 4Denmark
176NCT03315130
(ClinicalTrials.gov)
October 11, 201716/10/2017Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNULLCompleted18 Years85 YearsAll44Phase 2United States;Canada
177EUCTR2017-000323-27-NL
(EUCTR)
03/08/201718/04/2017A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravisA Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack.
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CV-MG01
INN or Proposed INN: Not applicable
Other descriptive name: T-peptide-CRM197 conjugate
INN or Proposed INN: Not applicable
Other descriptive name: B-peptide-CRM197 conjugate
CuraVac Europe SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 2;Phase 3Belgium;Netherlands
178EUCTR2017-000323-27-BE
(EUCTR)
19/06/201713/04/2017A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia GravisA Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack.
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CV-MG01
INN or Proposed INN: Not applicable
Other descriptive name: T-peptide-CRM197 conjugate
INN or Proposed INN: Not applicable
Other descriptive name: B-peptide-CRM197 conjugate
CuraVac Europe SANULLNot RecruitingFemale: yes
Male: yes
66Phase 2;Phase 3Belgium;Netherlands
179EUCTR2016-002698-36-CZ
(EUCTR)
26/05/201703/04/2017Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
180EUCTR2016-002698-36-ES
(EUCTR)
25/05/201731/03/2017Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
181EUCTR2016-002698-36-DK
(EUCTR)
19/05/201707/04/2017 Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
182NCT03052751
(ClinicalTrials.gov)
May 15, 201710/2/2017Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia GravisMyasthenia GravisDrug: UCB7665;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll43Phase 2United States;Belgium;Canada;Czechia;Denmark;Germany;Spain
183NCT03059888
(ClinicalTrials.gov)
April 12, 201717/2/2017Trial of Orencia in Patients With Myasthenia GravisPilot Trial of Orencia in Myasthenia Gravis Patients Inadequately Responsive to Conventional ImmunotherapyMyasthenia GravisDrug: Abatacept InjectionJohns Hopkins UniversityBristol-Myers SquibbTerminated16 Years85 YearsAll6Early Phase 1United States
184EUCTR2016-002698-36-DE
(EUCTR)
09/02/201728/11/2016Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
185NCT04101578
(ClinicalTrials.gov)
February 8, 201716/9/2019Clinical Prognosis and Progression of Myasthenia Gravis PatientsProspective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis PatientsMyasthenia GravisDrug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)Da, Yuwei, M.D.NULLRecruiting15 YearsN/AAll2000China
186EUCTR2016-002698-36-BE
(EUCTR)
30/01/201729/11/2016Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany
187NCT02965573
(ClinicalTrials.gov)
December 30, 201620/10/2016A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessMyasthenia GravisBiological: ARGX-113;Drug: PlaceboargenxQuintiles, Inc.Completed18 YearsN/AAll24Phase 2United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden
188EUCTR2016-002938-73-NL
(EUCTR)
08/12/201603/10/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
189EUCTR2016-002938-73-IT
(EUCTR)
01/12/201622/02/2018A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
Other descriptive name: ARGX-113
ARGEN-X BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Spain;Poland;Belgium;Netherlands;Italy;Sweden
190EUCTR2016-002938-73-ES
(EUCTR)
08/11/201626/09/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
191EUCTR2016-002938-73-BE
(EUCTR)
31/10/201613/09/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden
192NCT02950155
(ClinicalTrials.gov)
October 16, 201628/10/2016A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia GravisA Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG)Generalized Myasthenia GravisDrug: Rituximab;Drug: Sodium Chloride solutionFredrik PiehlNULLActive, not recruiting18 YearsN/AAll47Phase 3Sweden
193EUCTR2016-003138-26-NL
(EUCTR)
04/10/201608/08/2016Flu vaccine in patients with Myasthenia GravisInfluenza vaccination in patients with Myasthenia Gravis - Influenza vaccine in Myasthenia Gravis Myasthenia gravis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Influenza vaccine
Product Name: Influenza vaccine
LUMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
194ChiCTR1800017696
2016-07-012018-08-10Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia GravisEffect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis Myasthenia GravisGroup A:Magnesium Sulfate;Group B:Normal saline;The University of Hong Kong-Shenzhen HospitalNULLRecruiting1860BothGroup A:30;Group B:30;China
195EUCTR2015-005749-30-SE
(EUCTR)
23/06/201628/04/2016A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenghtA randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax New onset myasthenia gravis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Karolinska InstitutetNULLNot RecruitingFemale: yes
Male: yes
60Phase 3Sweden
196EUCTR2014-003997-18-DE
(EUCTR)
30/05/201627/07/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States
197NCT02609022
(ClinicalTrials.gov)
March 201613/11/2015Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia GravisA First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia GravisMyasthenia GravisBiological: CV-MG01;Biological: PlaceboCuraVacAepodia;University Hospital, Antwerp;Leiden University Medical CenterCompleted18 Years64 YearsAll24Phase 1/Phase 2Belgium
198EUCTR2013-005098-28-LV
(EUCTR)
17/12/201522/10/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
199EUCTR2013-005099-17-DE
(EUCTR)
18/11/201528/07/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
200EUCTR2013-002191-41-CZ
(EUCTR)
08/10/201531/08/2015EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
201EUCTR2013-005098-28-EE
(EUCTR)
07/10/201514/09/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Estonia;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
202EUCTR2014-003997-18-BE
(EUCTR)
06/10/201518/01/2016A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
203EUCTR2013-005099-17-BE
(EUCTR)
06/10/201515/01/2016A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
204EUCTR2015-003127-62-IT
(EUCTR)
02/10/201517/03/2017A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia GravisA Randomized, Placebo-Controlled, Pilot Crossover Study to Evaluate the Effect of Amifampridine Phosphate(3,4-Diaminopyridine Phosphate) in Patients with MuSK Antibody Positive Myasthenia Gravis - MuSK-001 Patients with MuSK Antibody Positive Myasthenia Gravis
MedDRA version: 19.1;Level: LLT;Classification code 10062976;Term: Neuromuscular weakness;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: AMIFAMPRIDINA
INN or Proposed INN: AMIFAMPRIDINA
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLNot RecruitingFemale: yes
Male: yes
20Phase 2Italy
205EUCTR2013-002191-41-FI
(EUCTR)
01/10/201525/09/2015 EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGreece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
206NCT02565576
(ClinicalTrials.gov)
September 29, 201523/6/2015Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: Placebo;Drug: CFZ533Novartis PharmaceuticalsNULLCompleted18 Years85 YearsAll44Phase 2Canada;Denmark;Germany;Russian Federation;Taiwan
207EUCTR2014-003997-18-CZ
(EUCTR)
10/09/201517/06/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
208EUCTR2013-005099-17-CZ
(EUCTR)
10/09/201517/06/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany
209EUCTR2015-000097-35-DK
(EUCTR)
03/09/201516/06/2015Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine.
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
Other descriptive name: CFZ533
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;Russian Federation;Denmark;Canada;Taiwan
210EUCTR2015-000097-35-DE
(EUCTR)
02/09/201505/06/2015Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine.
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
Other descriptive name: CFZ533
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
44Phase 2Taiwan;Canada;Denmark;Russian Federation;Germany
211EUCTR2013-002191-41-NL
(EUCTR)
31/08/201528/01/2015EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
212NCT02473952
(ClinicalTrials.gov)
August 201514/6/2015A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNULLCompleted18 Years85 YearsAll62Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
213EUCTR2013-005098-28-RO
(EUCTR)
21/07/201510/03/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Estonia;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Russian Federation;Latvia;Germany
214EUCTR2014-003997-18-HU
(EUCTR)
13/07/201526/05/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
215EUCTR2013-005099-17-HU
(EUCTR)
13/07/201526/05/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
216EUCTR2013-005098-28-PL
(EUCTR)
07/07/201501/06/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Russian Federation;South Africa;Latvia
217EUCTR2014-003997-18-LT
(EUCTR)
07/07/201525/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
218EUCTR2013-005099-17-LT
(EUCTR)
07/07/201525/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
219EUCTR2013-005099-17-EE
(EUCTR)
22/06/201526/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
220EUCTR2014-003997-18-EE
(EUCTR)
22/06/201526/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
221EUCTR2013-002191-41-DK
(EUCTR)
03/06/201516/04/2015EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
222NCT02473965
(ClinicalTrials.gov)
June 201514/6/2015Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia GravisA Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNULLCompleted18 Years85 YearsAll60Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
223NCT02100969
(ClinicalTrials.gov)
May 201527/3/2014Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia GravisOpen Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia GravisMyasthenia GravisDrug: HIZENTRA ®Mazen Dimachkie, MDCSL BehringCompleted18 YearsN/AAll23Phase 2United States;Canada
224EUCTR2013-002191-41-ES
(EUCTR)
29/04/201526/01/2015EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
225EUCTR2013-003589-15-CZ
(EUCTR)
22/04/201526/02/2015STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden;United Kingdom
226EUCTR2013-003589-15-HU
(EUCTR)
31/03/201520/01/2015STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
227EUCTR2013-005098-28-BE
(EUCTR)
13/03/201512/12/2014A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Estonia;Russian Federation;Israel;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;South Africa;Latvia;Germany;Netherlands;Korea, Republic of
228JPRN-UMIN000016564
2015/03/1323/02/2015Rituximab for intractable myasthenia gravis myasthenia gravisrituximabTokushima University HospitalNULLPending15years-old80years-oldMale and Female1Not selectedJapan
229NCT02413580
(ClinicalTrials.gov)
March 20157/4/2015A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis ExacerbationsA Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis ExacerbationsMyasthenia Gravis ExacerbationsBiological: IGIV-CGrifols Therapeutics LLCNULLCompleted18 YearsN/AAll49Phase 3Argentina;Belgium;Canada;Czechia;Estonia;France;Hungary;Latvia;Poland;Romania;Russian Federation;South Africa;Czech Republic
230EUCTR2013-002191-41-HU
(EUCTR)
27/02/201521/01/2015EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
231EUCTR2014-004344-35-NL
(EUCTR)
16/02/201516/02/2015The effect of tetanus revaccination in patients with myasthenia gravisThe effect of tetanus revaccination in patients with myasthenia gravis - Tetanus revaccination in patients with myasthenia gravis Myasthenia gravisLambert-Eaton myasthenic syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Tetanus vaccin
Product Name: Tetanus vaccin
Leiden University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
80Phase 4Netherlands
232EUCTR2013-005098-28-CZ
(EUCTR)
16/01/201503/10/2014A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLC.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
233EUCTR2013-002191-41-DE
(EUCTR)
23/12/201403/11/2014EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
234EUCTR2013-002191-41-SE
(EUCTR)
11/12/201413/11/2014EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
235EUCTR2013-005098-28-HU
(EUCTR)
21/11/201407/10/2014A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations Myasthenia Gravis Exacerbations
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Estonia;Russian Federation;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;South Africa;Netherlands;Latvia
236NCT02301624
(ClinicalTrials.gov)
November 12, 201422/11/2014Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia GravisA Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)Refractory Generalized Myasthenia GravisBiological: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll117Phase 3United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;Finland;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom
237EUCTR2013-002191-41-GB
(EUCTR)
27/10/201414/07/2014EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Spain;Ireland;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
238EUCTR2013-002191-41-BE
(EUCTR)
17/10/201402/09/2014EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
239EUCTR2013-002191-41-IT
(EUCTR)
05/10/201429/08/2014A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
240NCT02102594
(ClinicalTrials.gov)
October 201425/3/2014Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid ArthritisDrug: BortezomibCharite University, Berlin, GermanyProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, BerlinTerminated18 Years75 YearsAll11Phase 2Germany
241NCT02774239
(ClinicalTrials.gov)
October 201420/4/2015A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)A Pilot Trial To Assess The Feasibility And Efficacy Of Subcutaneous Immunoglobulin In Patients With Myasthenia Gravis ExacerbationMyasthenia GravisDrug: Human normal immunoglobulin G (IgG)University of AlbertaCSL BehringRecruiting18 Years80 YearsAll30Phase 3Canada
242EUCTR2013-003589-15-NL
(EUCTR)
09/09/201424/02/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden
243JPRN-UMIN000015019
2014/09/0202/09/2014Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG Myasthenia gravisTacrolimus and IVIGKansai medical universityNULLRecruitingNot applicableNot applicableMale and Female20Not applicableJapan
244EUCTR2014-001355-23-NL
(EUCTR)
29/08/201414/05/2014Ephedrine as add-on therapy for patients with myasthenia gravisEphedrine as add-on therapy for patients with myasthenia gravis - Ephedrine for MG myasthenia gravis
MedDRA version: 17.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hidrocloruro de efedrina
INN or Proposed INN: EPHEDRINE HYDROCHLORIDE
Other descriptive name: EPHEDRINE HYDROCHLORIDE
Leiden University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
245ChiCTR-IPR-15006081
2014-07-182015-03-14A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravisA prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis myasthenia gravisprednisone group:prednisone;Prednisone + methotrexate:Prednisone + methotrexate;Xuan Wu Hospital, Capital Medical UniversityNULLRecruiting1880Bothprednisone group:15;Prednisone + methotrexate:15;Phase 4NULL
246EUCTR2013-005362-19-DE
(EUCTR)
17/07/201418/12/2013Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB Myasthenia Gravis Systemic Lupus ErythematosusRheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Velcade®
INN or Proposed INN: BORTEZOMIB
Charité - Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
247EUCTR2013-003589-15-FI
(EUCTR)
04/06/201409/05/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
248EUCTR2013-003589-15-BE
(EUCTR)
28/05/201410/02/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
249EUCTR2013-003589-15-FR
(EUCTR)
20/05/201417/06/2015STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
250NCT02110706
(ClinicalTrials.gov)
May 20147/4/2014BeatMG: Phase II Trial of Rituximab In Myasthenia GravisB Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia GravisMyasthenia GravisDrug: Rituximab;Drug: PlaceboYale UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 Years90 YearsAll52Phase 2United States
251ChiCTR-OCC-14004533
2014-04-302014-04-16The superior anesthetic management scheme during perioperative period for myasthenia gravis patientsThe superior anesthetic management scheme during perioperative period for myasthenia gravis patients myasthenia gravisvolunteer:muscle relaxant monitor;MG group:muscle relaxant monitor;Yijishan Hospital, Wannan Medical College, Wuhu 241001, ChinaNULLCompleted1066Bothvolunteer:30;MG group:30;China
252EUCTR2013-003589-15-GR
(EUCTR)
29/04/201431/03/2014 STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
253EUCTR2013-003589-15-DK
(EUCTR)
29/04/201404/03/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
254EUCTR2013-003589-15-DE
(EUCTR)
07/04/201420/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
255EUCTR2013-003589-15-ES
(EUCTR)
24/02/201427/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
256EUCTR2013-003589-15-IT
(EUCTR)
11/02/201417/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
257EUCTR2013-003589-15-GB
(EUCTR)
03/02/201417/12/2013 STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
258EUCTR2013-003589-15-SE
(EUCTR)
03/02/201416/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden;Canada;Hungary;Czech Republic;France;United Kingdom;Switzerland;Italy;Austria;Turkey;Ireland;Spain;Finland;Greece;United States
259NCT01997229
(ClinicalTrials.gov)
December 201318/11/2013Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)Refractory Generalized Myasthenia GravisBiological: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll125Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom;Czech Republic
260JPRN-UMIN000012089
2013/10/1523/10/2013Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical studyTreatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study - Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study MuSK antibody-positive myasthenia gravisAdministration of Rituximab at the standard dose of 375 mg/m2 every week for 4 consecutive weeks and then monthly for the next 3 months.Department of NeurologyUniversity of Tokyo, Graduate School of MedicineNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not selectedJapan
261NCT01480596
(ClinicalTrials.gov)
April 201327/10/2011The Evaluation of Belimumab in Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG)Myasthaenia GravisBiological: Belimumab;Other: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll40Phase 2United States;Canada;Germany;Italy
262ChiCTR-OCC-13003090
2012-12-202013-03-02Research on micrornas expression of Myasthenia gravis and the relationship with TH1, TH2 cells secrete cytokinesResearch on micrornas expression of Myasthenia gravis and the relationship with TH1, TH2 cells secrete cytokines Myasthenia gravisexperimental group:Pyridostigmine Bromide;control group:nothing;The first affiliated hospital of Guangzhou university of Traditional Chinese medicineNULLCompleted1865Bothexperimental group:30;control group:30;China
263EUCTR2012-001544-21-ES
(EUCTR)
07/11/201223/08/2012Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis.Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis. Myasthenia gravis
MedDRA version: 15.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: PRIVIGEN
Other descriptive name: IMMUNOGLOBULIN G
Vall d'Hebron Institut de Recerca (VHIR)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Spain
264NCT01727193
(ClinicalTrials.gov)
September 20128/11/2012The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand ThymectomyMyasthenia GravisDrug: Azathioprine;Drug: LeflunomideFirst Affiliated Hospital, Sun Yat-Sen UniversityNULLRecruiting12 Years65 YearsAll158Phase 3China
265JPRN-UMIN000007671
2012/04/0109/04/2012Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients Myasthenia gravisAdministration of prednisolone 35 mg/day with tacrolimus 3mg a day
Administration of prednisolone 50 mg/day
Department of Neurology, Chiba University Graduate School of MedicineNULLRecruiting50years-oldNot applicableMale and Female40Not applicableJapan
266JPRN-UMIN000007679
2012/04/0109/04/2012Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients Myasthenia gravisAdministration of tacrolimus 3 mg/day
Administration of prednisolone 5 mg/day
anticholinesterases
Department of Neurology, Chiba University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
267NCT01555580
(ClinicalTrials.gov)
April 201213/3/2012A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia GravisA Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Symptomatic Autoimmune Generalized Myasthenia GravisMyasthenia GravisDrug: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)Muscular Dystrophy AssociationNULLNot yet recruiting18 Years80 YearsBoth12Phase 0United States
268EUCTR2011-002068-26-IT
(EUCTR)
28/12/201115/12/2011A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) - Evaluate the Use of Belimumab in Myasthenia Gravis (MG) Subjects with Generalized Myasthenia Gravis (MG)
MedDRA version: 14.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BENLYSTA® (belimumab)
INN or Proposed INN: BELIMUMAB
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
42United States;Canada;Germany;Italy
269NCT00995722
(ClinicalTrials.gov)
December 201114/10/2009Efficacy of Prednisone In the Treatment of Ocular MyastheniaEfficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' StudyOcular Myasthenia GravisDrug: Prednisone;Drug: PlaceboMichael BenatarUniversity of Miami;University of RochesterTerminated18 YearsN/AAll11Phase 3United States;Canada
270EUCTR2011-002068-26-DE
(EUCTR)
24/11/201105/10/2011A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG). Myasthenia Gravis
MedDRA version: 17.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BENLYSTA® (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
42United States;Canada;Germany;Italy
271NCT01828294
(ClinicalTrials.gov)
October 20111/11/2011Subcutaneous Ig Maintenance Therapy for Myasthenia GravisSubcutaneous Ig Maintenance Therapy for Myasthenia GravisMyasthenia GravisDrug: Subcutaneous immunoglobulinsSt. Louis UniversityCSL BehringTerminated18 Years80 YearsAll4Phase 1United States
272NCT01325571
(ClinicalTrials.gov)
March 201116/3/2011A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia GravisA Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid TherapyMyasthenia GravisDrug: Tacrolimus capsule;Drug: PlaceboAstellas Pharma IncAstellas Pharma China, Inc.Completed18 Years70 YearsBoth83Phase 3China
273NCT01268280
(ClinicalTrials.gov)
December 201028/12/2010Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia GravisA Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard TherapyMyasthenia GravisDrug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357CytokineticsNational Institute of Neurological Disorders and Stroke (NINDS)Terminated18 Years80 YearsAll32Phase 2United States
274ChiCTR-TRC-13004125
2010-10-012013-06-08The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patientsThe study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patients Myasthenia gravistrial:Jianji Ning Granule combined with olfactory pyridostigmine tablets ;Control:olfactory pyridostigmine tablets ;Longhua Hospital Affiliated to Shanghai University of traditional Chinese MedicineNULLCompleted1475Bothtrial:30;Control:30;I+2 (Phase 1+Phase 2)China
275EUCTR2009-014669-13-GB
(EUCTR)
29/12/200923/10/2009A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001 Generalized Myasthenia Gravis (gMG)
MedDRA version: 12.0;Level: LLT;Classification code 10028417;Term: Myasthenia gravis
Trade Name: SOLIRIS
Product Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
Alexion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
24United Kingdom
276NCT00987116
(ClinicalTrials.gov)
June 200929/9/2009Study Comparing Two Tapering Strategies of Prednisone in Myasthenia GravisComparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter StudyMyasthenia GravisDrug: Prednisone - AzathioprineAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years80 YearsAll118Phase 4France
277NCT00997412
(ClinicalTrials.gov)
May 200916/10/2009Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia GravisRandomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia GravisMyasthenia GravisDrug: Mycophenolic acid;Drug: AZAQualitix Clinical Research Co., Ltd.NULLActive, not recruiting20 Years70 YearsBoth40N/ANULL
278NCT00814138
(ClinicalTrials.gov)
April 200923/12/2008Efficacy of Methotrexate in Myasthenia GravisPhase II Trial of Methotrexate in Myasthenia GravisMyasthenia GravisDrug: Methotrexate;Other: PlaceboUniversity of Kansas Medical CenterNULLCompleted18 YearsN/AAll50Phase 2United States;Canada
279EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
280NCT00727194
(ClinicalTrials.gov)
October 200830/7/2008Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia GravisA Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With ImmunosuppressantsMyasthenia GravisDrug: eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLTerminated18 Years80 YearsAll14Phase 2United States;Canada;United Kingdom
281EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
282EUCTR2007-002817-37-IT
(EUCTR)
29/07/200830/06/2008A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - NDA PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND Patients affected with MG showing clinically meaningful improvement after therapeutic plasmapheresis.
MedDRA version: 9.1;Level: LLT;Classification code 10028417;Term: Myasthenia gravis
Product Name: PIXANTRONE
Product Code: BBR 2778
INN or Proposed INN: pixantrone
ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
283EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
284EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
285EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
286NCT00716066
(ClinicalTrials.gov)
June 200815/7/2008Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune DiseasesHigh-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic DiseasesAutoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute EncephalitisBiological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow TransplantationFred Hutchinson Cancer Research CenterNULLRecruitingN/A71 YearsAll40Phase 2United States
287NCT00774462
(ClinicalTrials.gov)
January 200816/10/2008Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia GravisFORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia GravisMyositis;Myasthenia GravisDrug: RituximabAssistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France;Roche Pharma AGCompleted18 Years80 YearsBoth30Phase 2France
288NCT00515450
(ClinicalTrials.gov)
July 200710/8/2007Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia GravisA Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: GB-0998 (Intravenous immunoglobulin);Procedure: PlasmapheresisBenesis CorporationNULLCompleted16 YearsN/ABoth46Phase 3Japan
289NCT01179893
(ClinicalTrials.gov)
March 20079/8/2010Intravenous Immunoglobulin and Plasma Exchange in Myasthenia GravisA Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia GravisMyasthenia GravidBiological: IVIG;Procedure: PLEXUniversity Health Network, TorontoGrifols Therapeutics Inc.Completed18 YearsN/ABoth87Phase 4Canada
290EUCTR2006-004374-27-DE
(EUCTR)
12/10/200607/09/2006Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIentProspective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0)Trade Name: Mutagrip
Product Name: Mutagrip
Philipps-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
291NCT00294658
(ClinicalTrials.gov)
June 200621/2/2006Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone TherapyA Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving PrednisoneMyasthenia GravisProcedure: thymectomy plus prednisone;Drug: prednisone aloneUniversity of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 Years65 YearsAll126Phase 3United States;Argentina;Australia;Brazil;Canada;Chile;Germany;Italy;Japan;Mexico;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom;Ireland
292NCT00309088
(ClinicalTrials.gov)
April 200629/3/2006FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) PatientsFK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis PatientsMyasthenia GravisDrug: tacrolimus;Drug: placeboAstellas Pharma IncNULLCompleted16 Years64 YearsBoth80Phase 3Japan
293EUCTR2005-000343-28-IT
(EUCTR)
29/03/200615/03/2006An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - NDAn optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND Myasthenia Gravis
MedDRA version: 6.1;Level: PT;Classification code 10028417
Trade Name: cellcept
INN or Proposed INN: Mycophenolic acid
ASPREVA PHARMACEUTICALS CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
136United Kingdom;Germany;Spain;Italy
294EUCTR2005-002740-26-GB
(EUCTR)
21/02/200601/12/2005A Phase II Double Blind, Cross-Over Study to Compare the Safety and Efficacy of 10, 20 and 40 mg Monarsen (EN101) administered to Patients with Myasthenia GravisA Phase II Double Blind, Cross-Over Study to Compare the Safety and Efficacy of 10, 20 and 40 mg Monarsen (EN101) administered to Patients with Myasthenia Gravis Myasthenia Gravis
MedDRA version: 8.1;Level: LLT;Classification code 10028417;Term: Myasthenia gravis
Product Name: MONARSEN
Product Code: EN101
Other descriptive name: MONARSEN
Other descriptive name: MONARSEN
Other descriptive name: MONARSEN
Ester Neuroscience LtdNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
295NCT00309101
(ClinicalTrials.gov)
February 200629/3/2006An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsFK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsMyasthenia GravisDrug: tacrolimusAstellas Pharma IncNULLCompleted16 Years64 YearsBoth11Phase 3Japan
296EUCTR2005-000343-28-DE
(EUCTR)
19/12/200510/05/2005An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) Myasthenia Gravis
MedDRA version: 8.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis
Trade Name: Cellcept 500 mg tablets
Product Name: CellCept 500 mg tablets
INN or Proposed INN: mycophenolate mofetil
Aspreva Pharmaceuticals CorporationNULLNot RecruitingFemale: yes
Male: yes
136Spain;Germany;Italy;United Kingdom
297EUCTR2004-000596-34-HU
(EUCTR)
30/09/200508/06/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. Myasthenia gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Trade Name: CellCept®500 mg tablets
Product Name: CellCept 500 mg film-coated tablets
INN or Proposed INN: mycophenolate mofetil
F. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease ProgramNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
298EUCTR2005-000343-28-GB
(EUCTR)
05/09/200528/06/2005An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) Myasthenia Gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Product Name: CellCept 500 mg tablets
INN or Proposed INN: mycophenolate mofetil
Aspreva Pharmaceutical CorporationNULLNot RecruitingFemale: yes
Male: yes
136Germany;United Kingdom;Spain;Italy
299EUCTR2004-000596-34-ES
(EUCTR)
01/09/200505/07/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. Myasthenia gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Trade Name: CellCept®500 mg tablets
Product Name: CellCept 500 mg film-coated tablets
INN or Proposed INN: mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3Hungary;Czech Republic;Spain;Italy
300EUCTR2004-000596-34-IT
(EUCTR)
01/06/200520/06/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG)A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) Myastenia gravis
MedDRA version: 6.1;Level: PT;Classification code 10028417
Trade Name: CELLCEPT
INN or Proposed INN: Mycophenolic acid
ASPREVA PHARMACEUTICALS CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
301EUCTR2004-000596-34-CZ
(EUCTR)
19/05/200506/05/2005A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravisA prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis Myasthenia gravis
MedDRA version: 7.1;Level: LLT;Classification code 10028417
Trade Name: CellCept 500 mg
Product Name: CellCept
F.Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
302NCT00683969
(ClinicalTrials.gov)
August 200419/5/2008A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia GravisA Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: mycophenolate mofetil (CellCept);Drug: placeboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years80 YearsBoth136Phase 3United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;United Kingdom
303NCT00408213
(ClinicalTrials.gov)
June 20045/12/2006A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of PrednisoneMyasthenia Gravis GeneralisedDrug: mycophenolate mofetil [CellCept];Drug: PlaceboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years80 YearsBoth136Phase 3United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands
304NCT00619671
(ClinicalTrials.gov)
April 200414/1/2008A Pilot Trial of Rituxan in Refractory Myasthenia GravisPhase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.Refractory Myasthenia GravisDrug: Rituximab (Rituxan)University of VermontGenentech, Inc.Completed18 Years80 YearsBoth10Phase 1/Phase 2United States
305NCT00306033
(ClinicalTrials.gov)
March 200421/3/2006Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia GravisIVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical TrialMyasthenia GravisDrug: Intravenous ImmuneGlobulinUniversity Health Network, TorontoNULLCompleted18 YearsN/ABoth50Phase 3Canada
306NCT00285350
(ClinicalTrials.gov)
September 200231/1/2006Mycophenolate Mofetil in Myasthenia GravisA Trial of Mycophenolate Mofetil in Myasthenia GravisMyasthenia GravisDrug: mycophenolate mofetilFDA Office of Orphan Products DevelopmentDuke UniversityCompleted18 YearsN/ABoth80Phase 3NULL
307NCT00424489
(ClinicalTrials.gov)
February 200218/1/2007Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia GravisHematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia GravisMyasthenia GravisBiological: Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: ATG (rabbit);Drug: Mesna;Drug: Methylprednisolone;Drug: G-CSFNorthwestern UniversityNULLTerminated15 Years65 YearsAll9Phase 1United States
308NCT00004682
(ClinicalTrials.gov)
March 199524/2/2000Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia GravisMyasthenia GravisDrug: immune globulinUniversity of TexasNULLTerminated15 YearsN/ABoth100N/ANULL
309EUCTR2020-005841-18-Outside-EU/EEA
(EUCTR)
12/08/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis. - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNAFemale: yes
Male: yes
Phase 2;Phase 3United Kingdom;United States;Georgia;Canada
310EUCTR2020-005841-18-PL
(EUCTR)
08/09/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNAFemale: yes
Male: yes
22Phase 2;Phase 3France;United States;Canada;Spain;Belgium;Poland;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
311EUCTR2020-005841-18-FR
(EUCTR)
21/07/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNAFemale: yes
Male: yes
12Phase 2;Phase 3United States;France;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
312EUCTR2020-004436-21-FR
(EUCTR)
12/04/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
313EUCTR2020-005841-18-NL
(EUCTR)
19/07/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNAFemale: yes
Male: yes
12Phase 2;Phase 3France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Germany;Netherlands;United Kingdom;Italy
314EUCTR2020-004436-21-PL
(EUCTR)
28/04/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
315EUCTR2021-002460-46-FR
(EUCTR)
08/02/2022Evaluating Long-term Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisA Long-term, Single-Arm, Open-label, Multicenter, Follow-on Trial of ARGX113-2006 to Evaluate Safety of Efgartigimod Administered Intravenously inChildren With Generalized Myasthenia Gravis - ADAPT JR.+ Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: efgartigimod
Product Code: argx-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNAFemale: yes
Male: yes
12Phase 2;Phase 3United States;France;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy