Iguratimod ( DrugBank: Iguratimod )

5 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	17
51	全身性強皮症	1
53	シェーグレン症候群	6
271	強直性脊椎炎	2
300	IgG4関連疾患	2

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

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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	NCT05626348 (ClinicalTrials.gov)	December 22, 2021	15/11/2022	The Clinical Efficacy of Immunomodulators in RA Patients	The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Pa ...	Arthritis, Rheumatoid	Drug: Iguratimod;Drug: Methotrexate;Drug: Adalimumab Injection;Drug: Leflunomide;Drug: Hydroxychloro ...	Qilu Hospital of Shandong University	NULL	Recruiting	18 Years	80 Years	All	400	Phase 4	China
2	ChiCTR2100048699	2021-05-25	2021-07-12	A multicentre, randomized, parallel-controlled clinical study of the efficacy and safety of Iguratim ...	Clinical cohort study of organ injury and repair in severe rheumatic diseases---rheumatoid arthritis ...	Rheumatoid Arthritis	A:Iguratimod combination therapy with JAK inhibitor;B:JAK inhibitor;	Qilu Hospital of Shandong University	NULL	Recruiting	18	65	Both	A:180;B:180;		China
3	ChiCTR2200055876	2020-12-01	2022-01-22	Efficacy and safety of Iguratimodcombined with adalimumab in active rheumatoid arthritis with poor r ...	Efficacy and safety of Iguratimodcombined with adalimumab in active rheumatoid arthritis with poor r ...	Rheumatoid Arthritis	Treatment group:IGU 25mg bid + adalimumab 40mg q2w;	Shandong Provincial Hospital Affiliated to Shandong First Medical University	NULL	Recruiting	18	65	Both	Treatment group:98;	Phase 4	China
4	NCT04928066 (ClinicalTrials.gov)	March 1, 2020	9/6/2021	The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA	Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate t ...	Arthritis, Rheumatoid	Drug: Iguratimod;Drug: Tofacitinib;Drug: Pred	Qilu Hospital of Shandong University	NULL	Recruiting	18 Years	80 Years	All	100	Phase 4	China
5	ChiCTR1900021686	2019-03-15	2019-03-05	A observational study for iguratimodcombined with methotrexate in remission or reversion bone erosio ...	A observational study for iguratimodcombined with methotrexate in remission or reversion bone erosio ...	Rheumatoid arthritis	Case Series:IGU combined with MTX ;	Nanjing Drum Tower Hospital	NULL	Pending	18	70	Both	Case Series:30;	Phase 4	China
6	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
7	JPRN-UMIN000027719	2017/06/12	12/06/2017	Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.	Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimodtherapy. - E ...	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
8	NCT03855007 (ClinicalTrials.gov)	January 1, 2016	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 Iguratimodin Rheumatoid Arthritis a ...	Arthritis, Rheumatoid	Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred	Qilu Hospital of Shandong University	NULL	Active, not recruiting	16 Years	90 Years	All	200	Phase 4	China
9	JPRN-UMIN000020833	2015/10/09	01/02/2016	The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an o ...	The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an o ...	Rheumatoid arthritis	Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA. If patients can't take MTX, administ ...	Zenjinkai Shimin-no-mori Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	240	Not selected	Japan
10	NCT02275299 (ClinicalTrials.gov)	September 2013	23/10/2014	Study of IguratimodPlus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheum ...	A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimodor Leflunomide in ...	Rheumatoid Arthritis	Drug: Iguratimod;Drug: Leflunomide;Drug: Methotrexate	Jiangsu Simcere Pharmaceutical Co., Ltd.	NULL	Recruiting	18 Years	70 Years	Both	240	Phase 4	China

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51. 全身性強皮症

臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217

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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

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53. シェーグレン症候群

臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

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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	NCT04830644 (ClinicalTrials.gov)	March 22, 2021	28/3/2021	A Study to Evaluate the Efficacy and Safety of IguratimodCompared to Placebo in Patients With Active ...	A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the ...	Primary Sjögren Syndrome	Drug: Iguratimod;Drug: Placebo	Jiangsu Simcere Pharmaceutical Co., Ltd.	NULL	Recruiting	18 Years	75 Years	All	144	Phase 2	China
2	ITMCTR1900002482	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
3	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
4	ChiCTR1900022696	2019-06-01	2019-04-22	A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment o ...	A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment o ...	Sjogren syndrome	experimental group :Iguratimod25mg bid po;control group:hydroxychloroquine 0.2-0.4g/d+prednison0.2-0 ...	Shanghai Tongji Hospital	NULL	Pending	18	70	Both	experimental group :60;control group:60;	Phase 4	China
5	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, placeb ...	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
6	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

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271. 強直性脊椎炎

臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146

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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	ChiCTR2100043171	2021-02-08	2021-02-07	Efficacy and safety of iguratimodcombined with NSAIDs in the treatment of AXSPA /AS in the real worl ...	Efficacy and safety of iguratimodcombined with NSAIDs in the treatment of AXSPA /AS in the real worl ...	Axial spinal arthritis/ankylosing spondylitis	test group:Iguratimod;	Qilu Hospital of Shandong University	NULL	Recruiting			Male	test group:278;	Phase 4	China
2	ChiCTR1800019227	2018-11-26	2018-10-31	A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Ig ...	A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Ig ...	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

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300. IgG4関連疾患

臨床試験数 : 40 / 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141

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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	ChiCTR2200062904	2022-08-23	2022-08-23	A multicenter, randomized, open-label clinical study on the efficacy and safety of iguratimodin the ...	A multicenter, randomized, open-label clinical study on the efficacy and safety of iguratimodin the ...	IgG4-related disease	glucocorticoid monotherapy group:glucocorticoid monotherapy;glucocorticoid combined with iguratimodg ...	Beijing Friendship Hospital Affiliated to Capital Medical University	NULL	Recruiting	18	100	Both	glucocorticoid monotherapy group:122;glucocorticoid combined with iguratimod group:122;	Phase 4	China
2	NCT03368274 (ClinicalTrials.gov)	September 1, 2017	20/9/2017	To Evaluate the Clinical Efficacy of Iguratimodin the Treatment of IgG4 Related Disease (IgG4-RD) Wi ...	To Evaluate the Clinical Efficacy of Iguratimodin the Treatment of IgG4 Related Disease (IgG4-RD) Wi ...	IgG4-related Disease	Drug: T 614	Wen Zhang	NULL	Unknown status	18 Years	70 Years	All	30	Phase 4	China

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