15. 封入体筋炎 Inclusion body myositis Clinical trials / Disease details
臨床試験数 : 42 / 薬物数 : 60 - (DrugBank : 16) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05272969 (ClinicalTrials.gov) | March 31, 2022 | 28/1/2022 | Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe Disease | Pompe & Pain - Observational Study to Assess Musculoskeletal Pain in Late-onset Pompe Disease (LOPD) | Pompe Disease (Late-onset);Inclusion Body Myositis;Spinal Muscular Atrophy Type 3;FSHD | Diagnostic Test: Beck depression inventory fast screen (Questionnaire);Diagnostic Test: Brief Pain Inventory (BPI) (Questionnaire);Diagnostic Test: German Pain Inventory (Questionnaire);Diagnostic Test: Fatigue Severity and Disability Scale (FSS) (Questionnaire);Diagnostic Test: Rotterdam Handicap Scale (RHS) (Questionnaire);Diagnostic Test: R-PAct (Questionnaire);Diagnostic Test: Quick Motor Function Test;Diagnostic Test: Handheld Dynamometry (HHD);Diagnostic Test: Six-minute walk test (6MWT);Diagnostic Test: Pressure pain threshold;Diagnostic Test: Muscle ultrasound;Diagnostic Test: Vital signs;Diagnostic Test: Borg Scale;Diagnostic Test: Laboratory assessment: Creatine kinase;Diagnostic Test: Laboratory assessment: Vitamin D Level;Diagnostic Test: Laboratory assessment: calcium;Diagnostic Test: Laboratory assessment: magnesium;Diagnostic Test: Laboratory assessment: phosphate;Genetic: Genetic test: ACE polymorphism;Genetic: Genetic test: ACTN3 polymorphism;Genetic: Blood draw for optional genetic exome sequencing | LMU Klinikum | NULL | Not yet recruiting | 18 Years | N/A | All | 95 | Germany | |
| 2 | NCT04789070 (ClinicalTrials.gov) | January 1, 2022 | 15/2/2021 | Phase III Trial of Sirolimus in IBM | A Double-Blind Randomised Controlled Trial (dbRCT) Phase III Trial Investigating the Effect of Sirolimus on Disease Progression in Patients With Inclusion Body Myositis (IBM) as Measured by the IBM Functional Rating Scale (IBM-FRS) | Inclusion Body Myositis | Drug: Sirolimus;Drug: Placebo | University of Kansas Medical Center | The Perron Institute | Not yet recruiting | 45 Years | N/A | All | 140 | Phase 3 | United States |
| 3 | NCT05032131 (ClinicalTrials.gov) | September 2021 | 27/8/2021 | Cell Therapy for IBM by Muscle Injection of ADSVF: a Phase I Trial | Cell Therapy for Inclusion Body Myositis (IBM) by Muscle Injection of Autologous Uncultured Adipose-Derived Stromal Vascular Fraction (ADSVF): a Phase I Trial | Inclusion Body Myositis | Biological: ADSVF | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 45 Years | 80 Years | All | 32 | Phase 1 | NULL |
| 4 | NCT04659031 (ClinicalTrials.gov) | May 25, 2021 | 25/11/2020 | A 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 Inclusion Body Myositis (IBM) | Inclusion Body Myositis | Drug: ABC008 | Abcuro, Inc. | NULL | Recruiting | 40 Years | N/A | All | 27 | Phase 1 | Australia |
| 5 | NCT04421677 (ClinicalTrials.gov) | August 20, 2020 | 18/5/2020 | Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis | Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis | Inclusion Body Myositis;Sporadic Inclusion Body Myositis | Drug: Phenylbutyrate Oral Tablet | University of Kansas Medical Center | NULL | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 6 | EUCTR2019-000749-11-GB (EUCTR) | 09/10/2019 | 20/06/2019 | An 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 | An 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;United Kingdom | ||
| 7 | NCT04049097 (ClinicalTrials.gov) | May 20, 2019 | 1/4/2019 | Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial | An 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 | Inclusion Body Myositis | Drug: Arimoclomol | Orphazyme | University of Kansas Medical Center;University College, London | Completed | 45 Years | N/A | All | 121 | Phase 3 | United States;United Kingdom |
| 8 | NCT03710941 (ClinicalTrials.gov) | February 19, 2019 | 15/10/2018 | Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenously Administered REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis | Drug: REGN2477+REGN1033;Drug: Matching placebo | Regeneron Pharmaceuticals | NULL | Withdrawn | 45 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 9 | EUCTR2017-004903-33-GB (EUCTR) | 18/06/2018 | 05/04/2018 | Study 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2;Phase 3 | United States;United Kingdom | ||
| 10 | NCT03440034 (ClinicalTrials.gov) | May 22, 2018 | 14/11/2017 | Study of Pioglitazone in Sporadic Inclusion Body Myositis | An Open-Label Pilot Study of Pioglitazone in Sporadic Inclusion Body Myositis | Myositis;Inclusion Body Myositis;Muscular Diseases;Musculoskeletal Disease;Neuromuscular Diseases;Nervous System Diseases | Drug: Pioglitazone | Johns Hopkins University | NULL | Completed | 50 Years | N/A | All | 19 | Phase 1 | United States |
| 11 | NCT02753530 (ClinicalTrials.gov) | August 16, 2017 | 25/4/2016 | Study of Arimoclomol in Inclusion Body Myositis (IBM) | Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM) | Inclusion Body Myositis | Drug: Arimoclomol;Other: Placebo | Orphazyme | University of Kansas Medical Center;University College, London | Completed | 45 Years | N/A | All | 152 | Phase 2 | United States;United Kingdom |
| 12 | EUCTR2015-001411-12-DK (EUCTR) | 10/11/2015 | 11/09/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | Extension 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Australia;Denmark;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 13 | EUCTR2015-001411-12-BE (EUCTR) | 09/11/2015 | 12/10/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | Extension 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 14 | EUCTR2015-001411-12-GB (EUCTR) | 04/11/2015 | 21/09/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | Extension 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;Switzerland;United Kingdom | ||
| 15 | EUCTR2015-001411-12-FR (EUCTR) | 04/11/2015 | 05/08/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | Extension 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;France;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 16 | NCT02573467 (ClinicalTrials.gov) | November 2, 2015 | 9/7/2015 | An 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 CBYM338B2203 | Extension 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 | Drug: Bimagrumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 36 Years | N/A | All | 211 | Phase 3 | United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom |
| 17 | JPRN-JapicCTI-153078 | 01/11/2015 | 25/11/2015 | Extension Study of the Long-term Efficacy and Safety of BYM338 in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203 | Extension 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 | Intervention 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. | NULL | 36 | BOTH | 240 | Phase 2-3 | NULL | ||
| 18 | EUCTR2015-001411-12-NL (EUCTR) | 22/10/2015 | 17/08/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | Extension 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 19 | EUCTR2015-001411-12-IT (EUCTR) | 14/10/2015 | 27/02/2018 | Extension study to evaluate the long-term efficacy, safety and tolerabilityof BYM338 in patients with sporadic inclusion body myositis | Extension 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;United Kingdom;Switzerland;Italy | ||
| 20 | NCT02481453 (ClinicalTrials.gov) | July 15, 2015 | 13/5/2015 | Rapamycine vs Placebo for the Treatment of Inclusion Body Myositis | Étude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMI | Inclusion Body Myositis (IBM) | Drug: Rapamycin;Drug: Placebo | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Completed | 45 Years | 85 Years | All | 44 | Phase 2/Phase 3 | France |
| 21 | NCT02317094 (ClinicalTrials.gov) | January 2015 | 10/12/2014 | Blood-flow Restricted Exercise in Inclusion Body Myositis | Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial | Sporadic Inclusion Body Myositis | Other: Blood-flow restricted training;Drug: Care as usual | University of Southern Denmark | Odense University Hospital | Completed | 35 Years | N/A | Both | 22 | N/A | Denmark |
| 22 | EUCTR2014-002210-23-DK (EUCTR) | 14/10/2014 | 02/06/2014 | Can 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] | Trade Name: Xeomin Product Name: Xeomin Other descriptive name: BOTULINUM TOXIN TYPE A | Rigshospitalet | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark | ||
| 23 | EUCTR2013-000705-23-DE (EUCTR) | 10/07/2014 | 16/01/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositis patients | A 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: BYM338 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Belgium;Poland;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan;Italy;Switzerland | ||
| 24 | EUCTR2013-000705-23-NL (EUCTR) | 01/07/2014 | 20/12/2013 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;France;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Switzerland;Japan;Italy | ||
| 25 | EUCTR2013-000705-23-GB (EUCTR) | 22/04/2014 | 31/01/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | A 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: BYM338 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;France;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Italy;Switzerland;United Kingdom | ||
| 26 | EUCTR2013-000705-23-DK (EUCTR) | 21/03/2014 | 10/03/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositis patients | A 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 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Italy;United Kingdom;Switzerland | ||
| 27 | NCT02250443 (ClinicalTrials.gov) | March 11, 2014 | 20/3/2014 | Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | An Open-label, Long-term Study to Evaluate the Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis (sIBM) | Drug: BYM338 (Bimagrumab) | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 75 Years | All | 10 | Phase 2/Phase 3 | United States |
| 28 | EUCTR2013-000705-23-BE (EUCTR) | 24/02/2014 | 27/01/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | A 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: BYM338 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;France;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Japan;Italy | ||
| 29 | EUCTR2013-000705-23-IT (EUCTR) | 09/02/2014 | 12/12/2013 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | A 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 SpA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Netherlands;France;United States;Belgium;Poland;Denmark;Australia;Germany;Japan;United Kingdom;Switzerland;Italy | ||
| 30 | NCT01925209 (ClinicalTrials.gov) | September 26, 2013 | 15/8/2013 | Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients | A 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 Myositis | Sporadic Inclusion Body Myositis | Drug: BYM338/bimagrumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 36 Years | 85 Years | All | 251 | Phase 2/Phase 3 | United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom;Germany;Poland |
| 31 | JPRN-JapicCTI-132365 | 01/9/2013 | 03/12/2013 | Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients | A 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 Myositis | Intervention 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. | NULL | 36 | 85 | BOTH | 240 | Phase 2-3 | NULL | |
| 32 | NCT02483845 (ClinicalTrials.gov) | May 2013 | 31/5/2013 | Natalizumab in Inclusion Body Myositis (IBM) | Pilot Study of Natalizumab in the Treatment of Patients With Inclusion Body Myositis | Inclusion Body Myositis (IBM) | Drug: Natalizumab | Phoenix Neurological Associates, LTD | NULL | Active, not recruiting | 21 Years | 85 Years | All | 6 | Phase 1 | United States |
| 33 | NCT01519349 (ClinicalTrials.gov) | January 2012 | 23/1/2012 | Follistatin Gene Transfer to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis | Phase I Clinical Intramuscular Gene Transfer of rAAV1.CMV.huFollistatin344 Trial to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis. | Becker Muscular Dystrophy;Sporadic Inclusion Body Myositis | Biological: rAAV1.CMV.huFollistatin344 | Nationwide Children's Hospital | Parent Project Muscular Dystrophy;The Myositis Association (Grant Sponsor) | Completed | 18 Years | N/A | All | 15 | Phase 1 | United States |
| 34 | NCT01423110 (ClinicalTrials.gov) | August 2011 | 12/8/2011 | Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis | Biological: BYM338;Biological: Placebo | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 80 Years | All | 14 | Phase 2 | United States |
| 35 | EUCTR2008-008208-42-GB (EUCTR) | 26/06/2009 | 29/05/2009 | A 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 | A 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 | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: Arimoclomol Other descriptive name: Arimoclomol | UCL - The Joint UCLH/UCL Comprehensive Biomedical Research Unit | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 36 | NCT00769860 (ClinicalTrials.gov) | September 2008 | 8/10/2008 | Arimoclomol in Sporadic Inclusion Body Myositis | Safety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body Myositis | Inclusion Body Myositis | Drug: Arimoclomol;Other: Placebo | Richard Barohn, MD | NULL | Completed | 50 Years | N/A | All | 24 | Phase 2/Phase 3 | United States;United Kingdom |
| 37 | EUCTR2007-004359-12-IT (EUCTR) | 05/04/2007 | 21/11/2007 | Simvastatin treatment in inclusion body myositis (IBM) - ND | Simvastatin 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 BESTA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 38 | EUCTR2006-005942-35-IT (EUCTR) | 14/03/2007 | 04/06/2007 | Simvastatin therapy in IBM - ND | Simvastatin 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 GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 39 | NCT00802815 (ClinicalTrials.gov) | April 2005 | 4/12/2008 | Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis | Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis | Inclusion Body Myositis | Drug: Etanercept | Washington University School of Medicine | Amgen | Completed | 18 Years | 80 Years | Both | 20 | Phase 0 | United States |
| 40 | NCT00079768 (ClinicalTrials.gov) | March 2004 | 12/3/2004 | Alemtuzumab to Treat Sporadic Inclusion Body Myositis | Effects of a T Cell-Depleting Monoclonal Antibody, Alemtuzumab, in Patients With Inclusion Body Myositis: A Pilot Clinicopathological Study | Myositis, Inclusion Body | Drug: Alemtuzumab (Campath) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 25 Years | 80 Years | Both | 20 | Phase 2 | United States |
| 41 | NCT01165008 (ClinicalTrials.gov) | September 2003 | 16/7/2010 | Anakinra in Myositis | Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies | Polymyositis;Dermatomyositis;Inclusion Body Myositis | Drug: Anakinra | Karolinska Institutet | NULL | Completed | 18 Years | 80 Years | Both | Phase 2/Phase 3 | Sweden | |
| 42 | NCT00001261 (ClinicalTrials.gov) | May 1990 | 3/11/1999 | Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies | The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-Over | Dermatomyositis;Inclusion Body Myositis;Polymyositis | Drug: Gamma Globulin | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 120 | Phase 2 | United States |