11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | ChiCTR2200058984 | 2022-05-01 | 2022-04-21 | Study on the dose-effect relationship of rituximab in patients with myasthenia gravis and the treatment differences of different doses based on population pharmacokinetic/pharmacodynamic model | Study on the dose-effect relationship of rituximab in patients with myasthenia gravis and the treatment differences of different doses based on population pharmacokinetic/pharmacodynamic model | myasthenia gravis | Standard dose group:Rituximab 400mg, once a week for 4 weeks;Low dose group:100mg, once a week, for 4 consecutive weeks or 100mg + 500mg single treatment; | Beijing Hospital | NULL | Pending | 18 | 80 | Both | Standard dose group:90;Low dose group:45; | N/A | China |
| 2 | EUCTR2020-005619-35-IT (EUCTR) | 07/06/2021 | 02/08/2021 | SINGLE-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 | SINGLE-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 CUORE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Italy | ||
| 3 | NCT05332587 (ClinicalTrials.gov) | August 1, 2020 | 4/12/2021 | Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis | Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis | Refractory Myasthenia Gravis;Rituximab | Drug: Rituximab | First Affiliated Hospital, Sun Yat-Sen University | NULL | Recruiting | N/A | 80 Years | All | 50 | Phase 3 | China |
| 4 | NCT02950155 (ClinicalTrials.gov) | October 16, 2016 | 28/10/2016 | A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis | A 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 Gravis | Drug: Rituximab;Drug: Sodium Chloride solution | Fredrik Piehl | NULL | Active, not recruiting | 18 Years | N/A | All | 47 | Phase 3 | Sweden |
| 5 | EUCTR2015-005749-30-SE (EUCTR) | 23/06/2016 | 28/04/2016 | A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenght | A 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 Institutet | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Sweden | ||
| 6 | JPRN-UMIN000016564 | 2015/03/13 | 23/02/2015 | Rituximab for intractable myasthenia gravis | Rituximab for intractable myasthenia gravis - Rituximab for myasthenia gravis | myasthenia gravis | rituximab | Tokushima University Hospital | NULL | Pending | 15years-old | 80years-old | Male and Female | 1 | Not selected | Japan |
| 7 | NCT02110706 (ClinicalTrials.gov) | May 2014 | 7/4/2014 | BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis | B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis | Myasthenia Gravis | Drug: Rituximab;Drug: Placebo | Yale University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 21 Years | 90 Years | All | 52 | Phase 2 | United States |
| 8 | JPRN-UMIN000012089 | 2013/10/15 | 23/10/2013 | Treatment 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 - Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study | MuSK antibody-positive myasthenia gravis | Administration 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 Medicine | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 5 | Not selected | Japan |
| 9 | NCT00774462 (ClinicalTrials.gov) | January 2008 | 16/10/2008 | Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis | FORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia Gravis | Myositis;Myasthenia Gravis | Drug: Rituximab | Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France;Roche Pharma AG | Completed | 18 Years | 80 Years | Both | 30 | Phase 2 | France |
| 10 | NCT00619671 (ClinicalTrials.gov) | April 2004 | 14/1/2008 | A Pilot Trial of Rituxan in Refractory Myasthenia Gravis | Phase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis. | Refractory Myasthenia Gravis | Drug: Rituximab (Rituxan) | University of Vermont | Genentech, Inc. | Completed | 18 Years | 80 Years | Both | 10 | Phase 1/Phase 2 | United States |