15. 封入体筋炎
[臨床試験数:39,薬物数:32(DrugBank:11),標的遺伝子数:11,標的パスウェイ数:119

Searched query = "Inclusion body myositis"
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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
34 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04659031
(ClinicalTrials.gov)
April 202125/11/2020A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)A Phase 1, Open-Label, Ascending Dose Study of ABC008 in Adult Patients With InclusionInclusion Body MyositisDrug: ABC008Abcuro, Inc.NULLNot yet recruiting40 YearsN/AAll39Phase 1NULL
2NCT04421677
(ClinicalTrials.gov)
August 20, 202018/5/2020Safety and Tolerability of Phenylbutyrate in Inclusion Body MyositisSafety and Tolerability of Phenylbutyrate in Inclusion Body MyositisInclusion Body Myositis;Sporadic Inclusion Body MyositisDrug: Phenylbutyrate Oral TabletUniversity of Kansas Medical CenterNULLActive, not recruiting18 YearsN/AAll10Phase 1United States
3EUCTR2019-000749-11-GB
(EUCTR)
09/10/201920/06/2019An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trialAn open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial. Sporadic Inclusion Body Myositis (sIBM)
MedDRA version: 21.1;Level: LLT;Classification code 10075052;Term: Sporadic inclusion body myositis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Other descriptive name: Arimoclomol citrate
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;United Kingdom
4NCT03710941
(ClinicalTrials.gov)
February 19, 201915/10/2018Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body MyositisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenously Administered REGN2477+REGN1033 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisDrug: REGN2477+REGN1033;Drug: Matching placeboRegeneron PharmaceuticalsNULLWithdrawn45 Years75 YearsAll0Phase 2NULL
5EUCTR2017-004903-33-GB
(EUCTR)
18/06/201805/04/2018Study of Arimoclomol in patients with Inclusion Body Myositis (IBM)Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM)A Randomized, Double-blind, Placebo-Controlled Trial Sporadic Inclusion Body Myositis (sIBM)
MedDRA version: 21.1;Level: LLT;Classification code 10075052;Term: Sporadic inclusion body myositis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Other descriptive name: Arimoclomol citrate
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2;Phase 3United States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03440034
(ClinicalTrials.gov)
May 22, 201814/11/2017Study of Pioglitazone in Sporadic Inclusion Body MyositisAn Open-Label Pilot Study of Pioglitazone in Sporadic Inclusion Body MyositisMyositis;Inclusion Body Myositis;Muscular Diseases;Musculoskeletal Disease;Neuromuscular Diseases;Nervous System DiseasesDrug: PioglitazoneJohns Hopkins UniversityNULLActive, not recruiting50 YearsN/AAll15Phase 1United States
7EUCTR2015-001411-12-DK
(EUCTR)
10/11/201511/09/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis Sporadic Inclusion Body Myositis
MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Australia;Denmark;Netherlands;Japan;Italy;United Kingdom;Switzerland
8EUCTR2015-001411-12-BE
(EUCTR)
09/11/201512/10/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis Sporadic Inclusion Body Myositis
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland
9EUCTR2015-001411-12-GB
(EUCTR)
04/11/201521/09/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis Sporadic Inclusion Body Myositis
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;Switzerland;United Kingdom
10EUCTR2015-001411-12-FR
(EUCTR)
04/11/201505/08/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis Sporadic Inclusion Body Myositis
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;France;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02573467
(ClinicalTrials.gov)
November 2, 20159/7/2015An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisDrug: Bimagrumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted36 YearsN/AAll211Phase 3United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom
12JPRN-JapicCTI-153078
01/11/201525/11/2015Extension Study of the Long-term Efficacy and Safety of BYM338 in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis Sporadic Inclusion Body MyositisIntervention name : BYM338
INN of the intervention : Bimagrumab
Dosage And administration of the intervention : BYM338 (High dose, Mid dose, Low dose or Placebo) will be continuously administered via intravenous infusion to randomized patients. Once the dose with the best benefit-risk profile is selected, all ongoing subjects will be switched to open-label treatment with BYM338 at the selected dose.
Control intervention name : null
Novartis Pharma K.K.NULL36BOTH240Phase 2b;Phase 3NULL
13EUCTR2015-001411-12-NL
(EUCTR)
22/10/201517/08/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis Sporadic Inclusion Body Myositis
MedDRA version: 19.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland
14EUCTR2015-001411-12-IT
(EUCTR)
14/10/201527/02/2018Extension study to evaluate the long-term efficacy, safety and tolerabilityof BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the longtermefficacy, safety and tolerability of intravenous BYM338 in patientswith sporadic inclusion body myositis - Extension study to evaluate the long-term efficacy, safety and tolerability Sporadic Inclusion Body Myositis
MedDRA version: 20.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Bimagrumab
Product Code: BYM338
NOVARTIS FARMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;United Kingdom;Switzerland;Italy
15NCT02481453
(ClinicalTrials.gov)
July 15, 201513/5/2015Rapamycine vs Placebo for the Treatment of Inclusion Body MyositisÉtude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMIInclusion Body Myositis (IBM)Drug: Rapamycin;Drug: PlaceboInstitut National de la Santé Et de la Recherche Médicale, FranceNULLCompleted45 Years85 YearsAll44Phase 2;Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-002210-23-DK
(EUCTR)
14/10/201402/06/2014Can local botulinum toxin improve swallowing difficulties in persons with msucle disease?Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle? Oculopharyngesl muscle dystrophy, inclusion body myositis
MedDRA version: 18.1;Level: LLT;Classification code 10019897;Term: Hereditary progressive muscular dystrophy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
RigshospitaletNULLNot Recruiting Female: yes
Male: yes
15Phase 2Denmark
17EUCTR2013-000705-23-DE
(EUCTR)
10/07/201416/01/2014 Study of efficacy and safety of BYM338 in sporadic inclusion body myositis patientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 16.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
240Phase 3United States;France;Belgium;Poland;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan;Italy;Switzerland
18EUCTR2013-000705-23-NL
(EUCTR)
01/07/201420/12/2013Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: na
Other descriptive name: na
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2b;Phase 3United States;France;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Switzerland;Japan;Italy
19EUCTR2013-000705-23-GB
(EUCTR)
22/04/201431/01/2014Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 16.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;France;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Italy;Switzerland;United Kingdom
20EUCTR2013-000705-23-DK
(EUCTR)
21/03/201410/03/2014Study of efficacy and safety of BYM338 in sporadic inclusion body myositis patientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
240Phase 3France;United States;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Italy;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02250443
(ClinicalTrials.gov)
March 11, 201420/3/2014Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisAn Open-label, Long-term Study to Evaluate the Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body Myositis (sIBM)Drug: BYM338 (Bimagrumab)Novartis PharmaceuticalsNULLCompleted40 Years75 YearsAll10Phase 2;Phase 3United States
22EUCTR2013-000705-23-BE
(EUCTR)
24/02/201427/01/2014Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2b;Phase 3United States;France;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Japan;Italy
23EUCTR2013-000705-23-IT
(EUCTR)
09/02/201412/12/2013Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 14.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BYM338
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Farma SpANULLNot RecruitingFemale: yes
Male: yes
240Phase 3Netherlands;France;United States;Belgium;Poland;Denmark;Australia;Germany;Japan;United Kingdom;Switzerland;Italy
24NCT01925209
(ClinicalTrials.gov)
September 26, 201315/8/2013Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM PatientsA Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisDrug: BYM338/bimagrumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted36 Years85 YearsAll251Phase 2;Phase 3United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom;Germany;Poland
25JPRN-JapicCTI-132365
01/9/201303/12/2013Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM PatientsA randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis Sporadic Inclusion Body MyositisIntervention name : BYM338
INN of the intervention : Bimagrumab
Dosage And administration of the intervention : BYM338 (High dose, Mid dose, Low dose or Placebo) will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Control intervention name : null
Novartis Pharma K.K.NULL3685BOTH240Phase 2b;Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02483845
(ClinicalTrials.gov)
May 201331/5/2013Natalizumab in Inclusion Body Myositis (IBM)Pilot Study of Natalizumab in the Treatment of Patients With Inclusion Body MyositisInclusion Body Myositis (IBM)Drug: NatalizumabPhoenix Neurological Associates, LTDNULLActive, not recruiting21 Years85 YearsAll6Phase 1United States
27NCT01423110
(ClinicalTrials.gov)
August 201112/8/2011Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisA Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisBiological: BYM338;Biological: PlaceboNovartis PharmaceuticalsNULLCompleted40 Years80 YearsAll14Phase 2United States
28EUCTR2008-008208-42-GB
(EUCTR)
26/06/200929/05/2009A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body MyositisA Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body Myositis The research project proposes to investigate Sporadic Inclusion Body Myositis (IBM). IBM is the commonest acquired disease of muscle affecting people aged 50 years and over. It is a progressive and debilitating disease which causes both muscle weakness and wasting, characteristically of the quadriceps and finger flexors. Over time it can lead to severe disability, falls and swallowing impairment. IBM is currently without a clinically proven, effective pharmacological treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10066407;Term: Inclusion body myositis
UCL - The Joint UCLH/UCL Comprehensive Biomedical Research UnitNULLNot Recruiting Female: yes
Male: yes
24Phase 2United Kingdom
29NCT00769860
(ClinicalTrials.gov)
September 20088/10/2008Arimoclomol in Sporadic Inclusion Body MyositisSafety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body MyositisInclusion Body MyositisDrug: Arimoclomol;Other: PlaceboRichard Barohn, MDNULLCompleted50 YearsN/AAll24Phase 2;Phase 3United States;United Kingdom
30EUCTR2007-004359-12-IT
(EUCTR)
05/04/200721/11/2007Simvastatin treatment in inclusion body myositis (IBM) - NDSimvastatin treatment in inclusion body myositis (IBM) - ND INCLUSION BODY MYOSITIS
MedDRA version: 6.1;Level: PT;Classification code 10028289
Trade Name: SIVASTIN
INN or Proposed INN: Simvastatin
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
ISTITUTO NEUROLOGICO CARLO BESTANULLNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-005942-35-IT
(EUCTR)
14/03/200704/06/2007Simvastatin therapy in IBM - NDSimvastatin therapy in IBM - ND inclusion body myositis
MedDRA version: 6.1;Level: PT;Classification code 10028641
Trade Name: SIVASTIN
INN or Proposed INN: Simvastatin
Trade Name: FLEBOGAMMA 5%
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
Italy
32NCT00079768
(ClinicalTrials.gov)
March 200412/3/2004Alemtuzumab to Treat Sporadic Inclusion Body MyositisEffects of a T Cell-Depleting Monoclonal Antibody, Alemtuzumab, in Patients With Inclusion Body Myositis: A Pilot Clinicopathological StudyMyositis, Inclusion BodyDrug: Alemtuzumab (Campath)National Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted25 Years80 YearsBoth20Phase 2United States
33NCT01165008
(ClinicalTrials.gov)
September 200316/7/2010Anakinra in MyositisAnakinra in Patients With Refractory Idiopathic Inflammatory MyopathiesPolymyositis;Dermatomyositis;Inclusion Body MyositisDrug: AnakinraKarolinska InstitutetNULLCompleted18 Years80 YearsBothPhase 2;Phase 3Sweden
34NCT00001261
(ClinicalTrials.gov)
May 19903/11/1999Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory MyopathiesThe Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-OverDermatomyositis;Inclusion Body Myositis;PolymyositisDrug: Gamma GlobulinNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth120Phase 2United States