Benepali ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 6 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | EUCTR2019-001754-25-NL (EUCTR) | 25/11/2019 | 25/11/2019 | Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment | Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch) | rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel, Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 4 | Netherlands | ||
| 2 | NCT03813771 (ClinicalTrials.gov) | March 2019 | 12/9/2018 | Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification | Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification. | Rheumatoid Arthritis | Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine | University of Leeds | Samsung Bioepis Co., Ltd. | Not yet recruiting | 18 Years | N/A | All | 106 | Phase 4 | United Kingdom |
| 3 | EUCTR2016-002344-16-GB (EUCTR) | 28/06/2018 | 29/11/2017 | Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency. | Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Benepali Product Name: Benepali INN or Proposed INN: ETANERCEPT | University of Leeds | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 4 | NCT03327454 (ClinicalTrials.gov) | August 10, 2017 | 11/10/2017 | Benepali® PEN Patient Satisfaction Survey | Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen | Rheumatoid Arthritis;Spondyloarthropathies | Biological: Benepali | Biogen | NULL | Completed | 18 Years | N/A | All | 500 | Germany | |
| 5 | NCT03100734 (ClinicalTrials.gov) | June 1, 2017 | 29/3/2017 | Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel | A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study | Rheumatoid Arthritis;Axial Spondyloarthritis | Biological: Benepali;Biological: Enbrel | Biogen | Samsung Bioepis Co., Ltd. | Completed | 18 Years | N/A | All | 585 | Germany | |
| 6 | EUCTR2015-004173-32-DK (EUCTR) | 18/12/2015 | 20/10/2015 | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study. | Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Department of Clinical Biochemestry, Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Denmark |