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 | NCT02418273 (ClinicalTrials.gov) | August 1, 2019 | 6/4/2015 | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study | Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis | Drug: denosumab | Indiana University | NULL | Withdrawn | 4 Years | 16 Years | All | 0 | Phase 1/Phase 2 | United States |
| 2 | JPRN-JapicCTI-184229 | 12/9/2018 | 03/12/2018 | Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe | Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study- | Rheumatoid Arthritis | Intervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | DAIICHISANKYO Co., Ltd. | NULL | other | BOTH | 2000 | NA | Japan | ||
| 3 | JPRN-jRCTs071180018 | 13/04/2018 | 15/02/2019 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Kawakami Atsushi | NULL | Complete | >= 20age old | Not applicable | Both | 44 | Phase 4 | Japan |
| 4 | JPRN-UMIN000030575 | 2018/03/31 | 26/12/2017 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Daiichi Sankyo Company, Limited | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 44 | Not applicable | Japan |
| 5 | JPRN-UMIN000030828 | 2018/01/15 | 15/01/2018 | The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. | The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. - EVIDENCE study | Rheumatoid ArthritisOsteoporosis | zoledronic acid denosumab | Osaka City University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 500 | Not selected | Japan |
| 6 | JPRN-JapicCTI-173747 | 01/11/2017 | 25/10/2017 | Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis - | Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis - | Rheumatoid Arthritis | Intervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | DAIICHISANKYO Co., Ltd. | NULL | complete | BOTH | 1000 | NA | Japan | ||
| 7 | JPRN-UMIN000028376 | 2017/07/26 | 01/08/2017 | Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis | Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis | rheumatoid arthritis | Combination of anti-rheumatic therapy and denosumab Anti-rheumatic therapy alone | Hokkaido Medical Center for Rheumatic Diseases | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 30 | Not selected | Japan |
| 8 | NCT03239080 (ClinicalTrials.gov) | June 19, 2017 | 1/8/2017 | Effect of Denosumab in Erosion Healing in RA | Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT | Rheumatoid Arthritis | Drug: Denosumab;Other: Placebo | Chinese University of Hong Kong | NULL | Completed | 18 Years | N/A | All | 110 | Phase 2 | China |
| 9 | JPRN-UMIN000014737 | 2014/08/01 | 01/08/2014 | The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. | The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. - Two Birds trial | rheumatoid arthritis | Denosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D. BP group: Patients take BP continuously. All patients are to take vitamin D. | Yokohama City University Medical Center | NULL | Complete: follow-up complete | 50years-old | 90years-old | Male and Female | 286 | Not selected | Japan |
| 10 | JPRN-JapicCTI-132277 | 01/10/2013 | AMG 162 Phase III study (DESIRABLE study) | A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III) | rheumatoid arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection Control intervention name : Placebo Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection | DAIICHISANKYO Co.,Ltd. | NULL | 20 | BOTH | 642 | Phase 3 | NULL | |||
| 11 | NCT01973569 (ClinicalTrials.gov) | October 2013 | 25/10/2013 | AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment | A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III) | Rheumatoid Arthritis | Drug: denosumab;Drug: placebo | Daiichi Sankyo, Inc. | NULL | Completed | 20 Years | N/A | All | 679 | Phase 3 | Japan |
| 12 | NCT01770106 (ClinicalTrials.gov) | December 2012 | 3/1/2013 | RA Denosumab on Bone Microstructure Study | Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Denosumab;Drug: Alendronate | Chinese University of Hong Kong | NULL | Completed | 18 Years | 80 Years | Female | 40 | Phase 4 | Hong Kong |
| 13 | NCT01294397 (ClinicalTrials.gov) | March 2011 | 13/1/2011 | Effects of Denosumab on the Pharmacokinetics of Etanercept | The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis | Postmenopausal;Osteopenia;Rheumatoid Arthritis;Osteoporosis | Drug: Etanercept;Drug: Denosumab | Amgen | NULL | Terminated | 45 Years | 80 Years | Female | 19 | Phase 1 | United States |
| 14 | JPRN-JapicCTI-101263 | 01/8/2010 | DRIVE | A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II) | Rheumatoid Arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneously for placebo | DAIICHISANKYO Co.,Ltd. | NULL | 20 | 75 | BOTH | 320 | Phase 2 | NULL | ||
| 15 | NCT00095498 (ClinicalTrials.gov) | August 2004 | 5/11/2004 | Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: placebo;Drug: denosumab | Amgen | NULL | Completed | 18 Years | N/A | All | 227 | Phase 2 | United States |