Iguratimod (DrugBank: Iguratimod)
4 diseases| 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 | 13 |
| 51 | 全身性強皮症 | 1 |
| 53 | シェーグレン症候群 | 4 |
| 271 | 強直性脊椎炎 | 1 |
| 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 | ChiCTR1900021686 | 2019-03-15 | 2019-03-05 | A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis | A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis | Rheumatoid arthritis | Case Series:IGU combined with MTX ; | Nanjing Drum Tower Hospital | NULL | Pending | 18 | 70 | Both | Case Series:30; | Phase 4 | China |
| 2 | ChiCTR1800015615 | 2018-05-01 | 2018-04-11 | Clinical observation of the protective effect of iguratimod on rheumatoid arthritis | Clinical observation of the protective effect of iguratimod on rheumatoid arthritis | Rheumatoid Arthritis | first:MTX;second:MTX in combination with Irammod;third:MTX and LEF;fourth:MTX, LEF and Irammod; | Tianjin First Central Hospital | NULL | Pending | 18 | 75 | Both | first:30;second:30;third:30;fourth:30; | China | |
| 3 | JPRN-UMIN000027719 | 2017/06/12 | 12/06/2017 | Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. | rheumatoid arthritis/remission | add-on iguratimod tapering MTX continuing the treatment | Osaka Medical College | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 100 | Not selected | Japan | |
| 4 | NCT03855007 (ClinicalTrials.gov) | January 1, 2017 | 15/2/2019 | The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred | Qilu Hospital of Shandong University | NULL | Recruiting | 16 Years | 90 Years | All | 200 | Phase 4 | China |
| 5 | JPRN-UMIN000020833 | 2015/10/09 | 01/02/2016 | The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. | Rheumatoid arthritis | Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA. If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks. Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks. If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA. | Zenjinkai Shimin-no-mori Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 240 | Not selected | Japan | |
| 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 |
| 6 | NCT02275299 (ClinicalTrials.gov) | September 2013 | 23/10/2014 | Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Leflunomide;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | Both | 240 | Phase 4 | China |
| 7 | NCT01850966 (ClinicalTrials.gov) | September 12, 2012 | 8/5/2013 | Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis | Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod | Eisai Co., Ltd. | NULL | Completed | N/A | N/A | All | 2747 | Japan | |
| 8 | JPRN-JapicCTI-132051 | 12/9/2012 | 23/01/2013 | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Rheumatoid Arthritis | Intervention name : iguratimod (Careram) Dosage And administration of the intervention : Oral | Eisai Co., Ltd. | NULL | BOTH | 2000 | NA | NULL | |||
| 9 | JPRN-JapicCTI-152782 | 12/9/2012 | 29/01/2015 | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Rheumatoid Arthritis | Intervention name : Kolbet INN of the intervention : Iguratimod Dosage And administration of the intervention : Oral | Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.) | NULL | BOTH | 2000 | NA | NULL | |||
| 10 | NCT01893151 (ClinicalTrials.gov) | July 2012 | 2/7/2013 | Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI | A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI) | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Iguratimod placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | Both | 200 | Phase 4 | China |
| 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 |
| 11 | NCT01554917 (ClinicalTrials.gov) | May 2012 | 12/3/2012 | A Study of Iguratimod in Patients With Active Rheumatoid Arthritis | A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Iguratimod | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 1759 | Phase 4 | China |
| 12 | NCT01548001 (ClinicalTrials.gov) | May 2012 | 5/3/2012 | Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 910 | Phase 4 | China |
| 13 | ChiCTR-TRC-10000850 | 2008-10-01 | 2010-04-26 | Phase III clinical trial of Iguratimodin rheumatoid arthritis | Phase III clinical trial of Iguratimodin rheumatoid arthritis | rheumatoid arthritis | 3:Experimental group: Iguratimod tablet, nimesulide dummy tablet; positive control group: taking nimesulide and Iguratimod dummy tablet; placebo group: taking Iguratimod dummy tablet and nimesulide dummy tablet. ; | Anhui Medical University | NULL | Completed | 18 | 65 | Both | 3:600; | 3 (Phase 3 study) | China |
| 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 | NCT04515706 (ClinicalTrials.gov) | January 1, 2021 | 13/8/2020 | Iguratimod in Systemic Sclerosis | Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis | Systemic Sclerosis, Diffuse | Drug: Iguratimod;Drug: Placebo | RenJi Hospital | NULL | Not yet recruiting | 19 Years | 74 Years | All | 20 | N/A | NULL |
| 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 | ChiCTR1900024642 | 2019-08-01 | 2019-07-19 | Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome | Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome | Primary Sjogren's Syndrome | Experimental group:Iguratimod+Prednisone;control group:HCQ+Prednisone; | Chongqing Hospital of Traditional Chinese Medcine | NULL | Recruiting | 18 | 65 | Both | Experimental group:30;control group:30; | N/A | China |
| 2 | ChiCTR1900022696 | 2019-06-01 | 2019-04-22 | A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome | A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome | Sjogren syndrome | experimental group :Iguratimod 25mg bid po;control group:hydroxychloroquine 0.2-0.4g/d+prednison0.2-0.5mg/kg.d; | Shanghai Tongji Hospital | NULL | Pending | 18 | 70 | Both | experimental group :60;control group:60; | Phase 4 | China |
| 3 | ChiCTR1900021345 | 2019-02-12 | 2019-02-16 | Effect of Iguratimod on Primary Sjogren's Syndrome | Observation of Iguratimod's Effect on Primary Sjogren's Syndrome, A randomized, double-blind, placebo-controlled trial | Primary Sjogren's Syndrome | Control group :Hydrochloroquine;Treatment group:Iguratimod; | Tianjin Medical University General Hospital | NULL | Recruiting | 18 | 75 | Both | Control group :30;Treatment group:30; | China | |
| 4 | NCT03023592 (ClinicalTrials.gov) | February 2017 | 15/1/2017 | Study of Iguratimod in Sjögren's Syndrome | A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome | Sjogren's Syndrome | Drug: Iguratimod | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 30 | Phase 1;Phase 2 | China |
| 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 | ChiCTR1800019227 | 2018-11-26 | 2018-10-31 | A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis(AS) | A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis | spondyloarthritis(SpA)/ankylosing spondylitis(AS) | spondyloarthritis(SpA)/ankylosing spondylitis(AS):Iguratimod;Control group:Placebo; | PLA General Hospital | NULL | Pending | 16 | 65 | Both | spondyloarthritis(SpA)/ankylosing spondylitis(AS):72;Control group:36; | China |