46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
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 | NCT02236481 (ClinicalTrials.gov) | July 2013 | 8/9/2014 | Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes | No-profit Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study | Diabetes Mellitus, Type 2;Arthritis, Rheumatoid | Drug: Anakinra;Drug: TNF alpha inhibitors | Prof. Roberto Giacomelli | NULL | Terminated | 18 Years | N/A | All | 41 | Phase 4 | Italy |
| 2 | EUCTR2012-005370-62-IT (EUCTR) | 18/02/2013 | 11/01/2013 | clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes. | No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study. | rheumatoid arthritis and type 2 diabetes mellitus as comorbidity. MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859 MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KINERET*SC 7SIR 100MG 0,67ML INN or Proposed INN: ANAKINRA | OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Italy | ||
| 3 | NCT02915094 (ClinicalTrials.gov) | October 2012 | 23/9/2016 | Kineret in the Treatment of Rheumatoid Arthritis | Kineret in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Anakinra | Swedish Orphan Biovitrum | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Germany |
| 4 | NCT01566201 (ClinicalTrials.gov) | March 2011 | 27/3/2012 | Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease | The Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid Arthritis | Rheumatoid Arthritis;Coronary Artery Disease;Inflammation | Drug: anakinra;Drug: placebo | University of Athens | NULL | Completed | 18 Years | N/A | Both | 80 | N/A | Greece |
| 5 | ChiCTR-TRC-09000383 | 2008-01-01 | 2009-04-23 | Efficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial | Efficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial | rheumatoid arthritis;M05.901 | placebo:daily subcutaneous injections of placebo, with concurrent MTX therapy ;anakinra:daily subcutaneous injections of anakinra (80 mg), with concurrent MTX therapy; | Xi-jing Hospital, the 4th Military Medical University, Shanghai Changzheng Hospital | NULL | Completed | 18 | 65 | Both | placebo:10;anakinra:30; | 3 (Phase 3 study) | China |
| 6 | NCT00111410 (ClinicalTrials.gov) | August 2005 | 20/5/2005 | Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA) | A Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Estimate the Effect of Anakinra (r-metHuIL-1ra) on Vaccine Antibody Response in Subjects With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Anakinra (r-metHuIL-1ra) | Amgen | NULL | Completed | 18 Years | 74 Years | Both | Phase 4 | NULL | |
| 7 | NCT00117091 (ClinicalTrials.gov) | September 2004 | 30/6/2005 | Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA) | An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Anakinra (Kineret®) | Amgen | NULL | Completed | 18 Years | N/A | Both | Phase 3 | NULL | |
| 8 | NCT00213538 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis | Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Response to anakinra associated with methotrexate | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | All | 341 | N/A | France |
| 9 | NCT00121043 (ClinicalTrials.gov) | October 2002 | 30/6/2005 | Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire | An Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported Questionnaire | Rheumatoid Arthritis | Device: SimpleJectTM;Drug: Kineret® (Anakinra) | Amgen | NULL | Completed | 18 Years | N/A | Both | Phase 4 | NULL | |
| 10 | NCT00537667 (ClinicalTrials.gov) | August 2001 | 27/9/2007 | The SPECTRA Study | A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: anakinra;Drug: anakinra and PEG sTNF-R1 | Amgen | NULL | Terminated | 18 Years | N/A | Both | 22 | Phase 2 | NULL |
| 11 | NCT00037700 (ClinicalTrials.gov) | May 2001 | 20/5/2002 | Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: anakinra;Drug: pegsunercept | Amgen | NULL | Completed | 18 Years | N/A | Both | Phase 2 | United States | ||
| 12 | NCT00037648 (ClinicalTrials.gov) | July 2000 | 17/5/2002 | Juvenile Rheumatoid Arthritis | A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis | Juvenile Chronic Arthritis | Drug: Anakinra;Drug: Placebo | Amgen | NULL | Completed | 2 Years | 17 Years | Both | 86 | Phase 2 | United States |
| 13 | EUCTR2015-002466-22-Outside-EU/EEA (EUCTR) | 23/12/2015 | A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis | A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: anakinra INN or Proposed INN: ANAKINRA | Amgen Inc | NULL | NA | Female: yes Male: yes | 90 | United States;Australia;Canada;Costa Rica;New Zealand |