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Solu-medrol    (DrugBank: -)

7 diseases
告示番号疾患名（ページ内リンク）臨床試験数
13多発性硬化症／視神経脊髄炎7
49全身性エリテマトーデス1
50皮膚筋炎／多発性筋炎1
51全身性強皮症1
53シェーグレン症候群1
97潰瘍性大腸炎1
211左心低形成症候群1

13. 多発性硬化症／視神経脊髄炎　［臨床試験数：3,050，薬物数：2,147（DrugBank：348），標的遺伝子数：244，標的パスウェイ数：228］
Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 3,050 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2018-000620-34-SE
(EUCTR)		24/04/201814/03/2018Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		INN or Proposed INN: IMATINIB MESILATE
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		200Phase 2Sweden
2EUCTR2010-023560-40-SE
(EUCTR)		23/03/201121/12/2010Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders		Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol		Uppsala l?ns landstingNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		120United States;Canada;Brazil;Sweden
3EUCTR2009-013884-21-PL
(EUCTR)		20/05/201013/01/2010A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes		90Germany;Belgium;Poland
4NCT01039103
(ClinicalTrials.gov)		December 200920/12/2009Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated SyndromeDrug: PEG-liposomal prednisolone sodium phosphate;Drug: MethylprednisoloneGalapagos NVNULLTerminated18 Years65 YearsBoth15Phase 2Belgium;Germany;Poland
5EUCTR2009-013884-21-DE
(EUCTR)		18/11/200909/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes		90Poland;Belgium;Germany
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2009-013884-21-BE
(EUCTR)		13/11/200910/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis		Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		90Phase 2Poland;Belgium;Germany
7EUCTR2009-011516-37-DK
(EUCTR)		29/05/200915/05/2009Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMSDouble blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS Multiple Sclerosis, with primary and secondary progressive courses.
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis		Trade Name: NeoRecormon
INN or Proposed INN: Solu-Medrol
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		Danish Multiple Sclerosis Research CentreNULLNot RecruitingFemale: yes
Male: yes		Phase 2Denmark

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49. 全身性エリテマトーデス　［臨床試験数：827，薬物数：638（DrugBank：168），標的遺伝子数：108，標的パスウェイ数：191］
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 827 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT04233164
(ClinicalTrials.gov)		March 4, 202016/1/2020Genomic Effects of Glucocorticoids in Patients With Systemic Lupus ErythematosusGenomic Effects of Glucocorticoids in Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematous (SLE)Drug: SOLU-MEDROLNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLRecruiting18 Years80 YearsAll100Early Phase 1United States

50. 皮膚筋炎／多発性筋炎　［臨床試験数：157，薬物数：207（DrugBank：76），標的遺伝子数：47，標的パスウェイ数：142］
Searched query = "Dermatomyositis", "Polymyositis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 157 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2007-004410-13-CZ
(EUCTR)		12/03/200825/10/2007A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUSA PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS active polymyositis, dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis
MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis		Trade Name: Methotrexat Lachema 2,5mg
Product Name: Methotrexat Lachema 2,5mg tbl.
Product Code: 44/154/85-C
INN or Proposed INN: METHOTREXATE
Other descriptive name: methotrexate
Trade Name: Prednison 5, 20 Léciva por. tablet nob.
Product Name: Prednison 5, 20 Léciva por. tablet nob.
Product Code: 56/104/75-C
INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob
Trade Name: Methotrexat Lachema 5 inj. sol
Product Name: Methotrexate Lachema 5inj. sol
Product Code: 44/196/81-C
INN or Proposed INN: methotrexate
Trade Name: Solu-medrol inj. PSO LQF 40mg
Product Name: Solu-medrol inj. PSO lqf 40mg
INN or Proposed INN: methylprednisoloni natrii succinas		Institute od Rheumatology PragueNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		50Czech Republic;Sweden

51. 全身性強皮症　［臨床試験数：466，薬物数：536（DrugBank：142），標的遺伝子数：110，標的パスウェイ数：210］
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 466 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-004613-24-BE
(EUCTR)		17/07/201918/04/2019Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Solu-Medrol
Product Name: methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		30Phase 4Belgium;Netherlands

53. シェーグレン症候群　［臨床試験数：234，薬物数：270（DrugBank：85），標的遺伝子数：49，標的パスウェイ数：174］
Searched query = "Sjogren syndrome", "Sjögren syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 234 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-000400-26-IT
(EUCTR)		18/01/201610/11/2020A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML
Product Name: MABTHERA
Product Code: [NA]
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO
Product Name: BENLYSTA
Product Code: [na]
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: SOLU-MEDROL
Product Code: [na]
INN or Proposed INN: METILPREDNISOLONE
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [na]
INN or Proposed INN: PARACETAMOLO
Trade Name: XYZAL - 20 COMPRESSE RI		GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes		120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden

97. 潰瘍性大腸炎　［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 2,269 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03942861
(ClinicalTrials.gov)		February 21, 201925/4/2019Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Ulcerative Colitis;Ultrasound Therapy; ComplicationsDrug: Solu-MedrolCopenhagen University Hospital at HerlevNULLRecruiting18 Years70 YearsAll50Denmark

211. 左心低形成症候群　［臨床試験数：20，薬物数：28（DrugBank：9），標的遺伝子数：5，標的パスウェイ数：13］
Searched query = "Hypoplastic left heart syndrome", "HLHS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 20 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2008-007413-76-FI
(EUCTR)		27/02/200923/12/2008Metyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessäMetyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessä Lasten ja nuorten sairaalassa (HUS) hoidettavat 1-12 kk ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikanan TOF, AVSD tai VSD.Lasten ja nuorten sairaalassa (HUS) hoidettavat korkeintaan 28 päivän ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikana TGA, HLHS tai IAA.
MedDRA version: 9.1;Level: LLT;Classification code 10010495;Term: Congenital heart disease NOS		Trade Name: Solu-Medrol
INN or Proposed INN: metyyliprednisoloninatriumsuksinaatti
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE		Pertti SuominenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		105Finland

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