15. 封入体筋炎 Inclusion body myositis Clinical trials / Disease details
臨床試験数 : 42 / 薬物数 : 33 - (DrugBank : 11) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123
Showing 1 to 10 of 12 diseases
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 |
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1 | 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 study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients wi ... | 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 Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tol ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: I ... | 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 | ||
2 | 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 study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients wi ... | 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 Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tol ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: I ... | 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 | ||
3 | 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 study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients wi ... | 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 Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tol ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: I ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;Switzerland;United Kingdom | ||
4 | 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 study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients wi ... | 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 Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tol ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: I ... | 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 | ||
5 | 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 An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With ... | 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 Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tol ... | 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 |
6 | 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 Study of the Long-term Efficacy and Safety of BYM338 in Patients With Sporadic Inclusion B ... | 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 Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tol ... | 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 Intervention name : BYM338 INN of the intervention : Bimagrumab Dosage And administration of the inter ... | Novartis Pharma K.K. | NULL | 36 | BOTH | 240 | Phase 2-3 | NULL | ||
7 | 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 study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients wi ... | 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 Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tol ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 19.0;Level: PT;Classification code 10066407;Term: I ... | 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 | ||
8 | 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 study to evaluate the long-term efficacy, safety and tolerabilityof BYM338 in patients wit ... | 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 Extension of the CBYM338B2203 phase IIb/III study to evaluate the longtermefficacy, safety and toler ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 20.0;Level: PT;Classification code 10066407;Term: I ... | 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 | ||
9 | 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 Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body ... | An Open-label, Long-term Study to Evaluate the Safety and 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 Sp ... | Sporadic Inclusion Body Myositis (sIBM) | Drug: BYM338 (Bimagrumab) | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 75 Years | All | 10 | Phase 2/Phase 3 | United States |
10 | 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 A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, ... | 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] Sporadic Inclusion Body Myositis MedDRA version: 14.1;Level: PT;Classification code 10066407;Term: I ... | 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 Netherlands;France;United States;Belgium;Poland;Denmark;Australia;Germany;Japan;United Kingdom;Switz ... |