DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
13	多発性硬化症／視神経脊髄炎	2
34	神経線維腫症	1
41	巨細胞性動脈炎	1
43	顕微鏡的多発血管炎	2
44	多発血管炎性肉芽腫症	2
45	好酸球性多発血管炎性肉芽腫症	2
46	悪性関節リウマチ	35
48	原発性抗リン脂質抗体症候群	2
49	全身性エリテマトーデス	14
53	シェーグレン症候群	9
56	ベーチェット病	1
66	IgA腎症	3
84	サルコイドーシス	2
89	リンパ脈管筋腫症	1
90	網膜色素変性症	1
96	クローン病	1
218	アルポート症候群	1
222	一次性ネフローゼ症候群	1
234	ペルオキシソーム病（副腎白質ジストロフィーを除く。）	1
254	ポルフィリン症	1
271	強直性脊椎炎	1
298	遺伝性膵炎	1
299	嚢胞性線維症	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	NCT03109288 (ClinicalTrials.gov)	August 11, 2017	11/4/2017	Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)	Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)	Multiple Sclerosis	Drug: Pioglitazone;Drug: clemastine fumarate;Drug: Hydroxychloroquine;Drug: Dantrolene	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Recruiting	18 Years	N/A	All	250	Phase 1;Phase 2	United States
2	NCT02913157 (ClinicalTrials.gov)	November 2016	20/9/2016	Hydroxychloroquine in Primary Progressive Multiple Sclerosis	Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)	Multiple Sclerosis, Primary Progressive	Drug: Hydroxychloroquine	University of Calgary	NULL	Active, not recruiting	18 Years	65 Years	All	35	Phase 2	Canada

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	NCT04201457 (ClinicalTrials.gov)	November 20, 2019	12/12/2019	A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration	Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-associated Recurrent or Progressive Gliomas in Children and Young Adults	Low Grade Glioma (LGG) of Brain With BRAF Aberration;High Grade Glioma (HGG) of the Brain With BRAF Aberration;Low Grade Glioma of Brain With Neurofibromatosis Type 1	Drug: Dabrafenib;Drug: Trametinib;Drug: Hydroxychloroquine	Pediatric Brain Tumor Consortium	NULL	Recruiting	1 Year	30 Years	All	75	Phase 1;Phase 2	United States

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	NCT00430807 (ClinicalTrials.gov)	January 2002	31/1/2007	Hydroxychloroquine in Giant Cell Arteritis	Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.	Giant Cell Arteritis	Drug: hydroxychloroquine/placebo	University Hospital, Toulouse	NULL	Completed	18 Years	85 Years	Both	75	Phase 3	France

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	NCT04316494 (ClinicalTrials.gov)	April 2020	25/2/2020	Hydroxychloroquine in ANCA Vasculitis Evaluation	Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial	ANCA Associated Vasculitis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Wegener Granulomatosis	Drug: Hydroxychloroquine;Drug: Placebo	Guy's and St Thomas' NHS Foundation Trust	Medical Research Council	Not yet recruiting	18 Years	N/A	All	76	Phase 4	NULL
2	EUCTR2018-001268-40-GB (EUCTR)	23/01/2020	13/09/2019	Hydroxychloroquine in ANCA vasculitis	Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial - HAVEN	The term ANCA-associated vasculitis (AAV) describes a subset of primary small vessel vasculitides characterized by the presence of anti-neutrophil cytoplasmic antibodies (ANCA): Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and Eosinophilic Granulomatosis with Polyangiitis (EGPA). AAV are serious multisystem autoimmune disorders that can affect any organ in the body and commonly involve the ear-nose-throat, lungs, kidneys, eyes and joints MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Plaquenil - Hydroxychloroquine 200mg Film coated tablets	Guy's and St. Thomas' NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	76	Phase 4	United Kingdom

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	NCT04316494 (ClinicalTrials.gov)	April 2020	25/2/2020	Hydroxychloroquine in ANCA Vasculitis Evaluation	Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial	ANCA Associated Vasculitis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Wegener Granulomatosis	Drug: Hydroxychloroquine;Drug: Placebo	Guy's and St Thomas' NHS Foundation Trust	Medical Research Council	Not yet recruiting	18 Years	N/A	All	76	Phase 4	NULL
2	EUCTR2018-001268-40-GB (EUCTR)	23/01/2020	13/09/2019	Hydroxychloroquine in ANCA vasculitis	Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial - HAVEN	The term ANCA-associated vasculitis (AAV) describes a subset of primary small vessel vasculitides characterized by the presence of anti-neutrophil cytoplasmic antibodies (ANCA): Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and Eosinophilic Granulomatosis with Polyangiitis (EGPA). AAV are serious multisystem autoimmune disorders that can affect any organ in the body and commonly involve the ear-nose-throat, lungs, kidneys, eyes and joints MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Plaquenil - Hydroxychloroquine 200mg Film coated tablets	Guy's and St. Thomas' NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	76	Phase 4	United Kingdom

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	NCT04316494 (ClinicalTrials.gov)	April 2020	25/2/2020	Hydroxychloroquine in ANCA Vasculitis Evaluation	Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial	ANCA Associated Vasculitis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Wegener Granulomatosis	Drug: Hydroxychloroquine;Drug: Placebo	Guy's and St Thomas' NHS Foundation Trust	Medical Research Council	Not yet recruiting	18 Years	N/A	All	76	Phase 4	NULL
2	EUCTR2018-001268-40-GB (EUCTR)	23/01/2020	13/09/2019	Hydroxychloroquine in ANCA vasculitis	Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial - HAVEN	The term ANCA-associated vasculitis (AAV) describes a subset of primary small vessel vasculitides characterized by the presence of anti-neutrophil cytoplasmic antibodies (ANCA): Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and Eosinophilic Granulomatosis with Polyangiitis (EGPA). AAV are serious multisystem autoimmune disorders that can affect any organ in the body and commonly involve the ear-nose-throat, lungs, kidneys, eyes and joints MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Plaquenil - Hydroxychloroquine 200mg Film coated tablets	Guy's and St. Thomas' NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	76	Phase 4	United Kingdom

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	NCT04569890 (ClinicalTrials.gov)	December 1, 2020	20/9/2020	Treatment of Pregnancy RA	Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China	Rheumatoid Arthritis;Pregnancy Related	Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone	RenJi Hospital	NULL	Not yet recruiting	20 Years	40 Years	Female	100	N/A	China
2	NCT04347798 (ClinicalTrials.gov)	September 2020	13/4/2020	IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT	IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT	Covid-19 Infection;Rheumatoid Arthritis;Psoriatic Arthritis;Hydroxychloroquine	Other: Hydroxychloroquine/Chloroquine	University of Alberta	NULL	Enrolling by invitation	18 Years	N/A	All	500		Canada
3	NCT04389320 (ClinicalTrials.gov)	March 15, 2020	11/5/2020	Antimalarial and Covid 19 in Rheumatoid Arthritis	Antimalarial and Covid 19 in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Hydroxychloroquine	Assiut University	NULL	Completed	20 Years	70 Years	All	60		Egypt
4	ChiCTR2000032534	2019-05-15	2020-05-01	Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study	Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study	Rheumatoid arthritis	Experimental group:Anbainuo plus methotrexate;Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine;	The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.	NULL	Completed			Both	Experimental group:47;Control group:43;	Phase 4	China
5	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
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	NCT03449758 (ClinicalTrials.gov)	March 5, 2018	8/2/2018	Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis	Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors	Rheumatoid Arthritis	Drug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	84	Phase 4	France
7	JPRN-jRCTs031180050	26/12/2017	07/12/2018	Hydroxychloroquine for Japanese patients with rheumatoid arthritis	Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis	Rheumatoid arthritis;D001172	Treatment with hydroxychloroquine for 24 weeks	Kaneko Yuko	NULL	Recruiting	>= 18age old	Not applicable	Both	120		Japan
8	NCT03085940 (ClinicalTrials.gov)	January 20, 2017	7/2/2017	Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis	Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Hydroxychloroquine;Drug: Placebo	Indonesia University	NULL	Completed	18 Years	N/A	All	37	N/A	Indonesia
9	NCT02930343 (ClinicalTrials.gov)	September 2016	13/9/2016	Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy	Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine	Jawaharlal Institute of Postgraduate Medical Education & Research	NULL	Completed	18 Years	65 Years	All	136	Phase 3	India
10	NCT02603146 (ClinicalTrials.gov)	April 27, 2016	10/11/2015	Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis	Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis	Healthy Participants;Rheumatoid Arthritis (RA) Prevention	Drug: Hydroxychloroquine;Drug: HCQ Placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Recruiting	18 Years	N/A	All	200	Phase 2	United States
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	NCT02714634 (ClinicalTrials.gov)	March 2016	1/2/2016	Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate	Randomized Controlled Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate	Rheumatoid Arthritis;Insufficient Response to Methotrexate.	Drug: Methotrexate + biologic administration;Drug: methotrexate + salazopyrine + hydroxychloroquine administration	University Hospital, Strasbourg, France	NULL	Not yet recruiting	18 Years	N/A	Both	286	Phase 4	NULL
12	NCT02644499 (ClinicalTrials.gov)	December 31, 2015	30/12/2015	Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis	Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid	Jawaharlal Institute of Postgraduate Medical Education & Research	NULL	Completed	18 Years	N/A	All	186	Phase 4	India
13	NCT02320630 (ClinicalTrials.gov)	October 2015	16/12/2014	Combination Therapy Prevents the Relapse of RA	The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity	Recurrence (Disease Attribute)	Drug: Entanercept;Drug: HCQ;Drug: MTX	Peking University First Hospital	Peking University People's Hospital;Peking University Third Hospital;Beijing Hospital;Beijing Jishuitan Hospital;Peking University Shougang Hospital;Beijing Shijitan Hospital	Recruiting	18 Years	70 Years	All	240	N/A	China
14	NCT02451748 (ClinicalTrials.gov)	August 2015	6/5/2015	IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA	IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA	Rheumatoid Arthritis	Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira	University of Illinois at Chicago	UCB Pharma	Completed	18 Years	N/A	All	32	Phase 4	United States
15	EUCTR2014-005418-45-SE (EUCTR)	04/05/2015	18/03/2015	Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)	Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE	Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE	Christine Bengtsson	Solveig Wållberg-Jonsson	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
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
16	EUCTR2011-004720-35-NO (EUCTR)	04/05/2015	26/01/2015	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Sweden
17	NCT02466581 (ClinicalTrials.gov)	February 3, 2015	29/5/2015	Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity	A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity	Rheumatoid Arthritis	Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra	Karolinska Institutet	NULL	Active, not recruiting	18 Years	N/A	All	25	Phase 4	Sweden
18	EUCTR2011-004720-35-FI (EUCTR)	10/09/2014	09/09/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Sweden
19	ChiCTR1900026116	2014-06-01	2019-09-22	The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial	The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial	rheumatoid arthritis	Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine;	Central Hospital of Jinhua	NULL	Completed	21	73	Both	Experimental group:40;control group:40;	Phase 4	China
20	ChiCTR-TRC-14004520	2014-05-01	2014-04-13	To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water	To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water metabolism	rheumatoid arthritis	two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA;	General Hospital of Chengdu Military Region	NULL	Recruiting	45	65	Both	two:240;RA patients:40;	I (Phase 1 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
21	NCT02057250 (ClinicalTrials.gov)	March 2014	31/1/2014	To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis	A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy	RA	Drug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Hydroxychloroquine	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	217	Phase 3	United States;Chile;Mexico;Poland;Russian Federation;South Africa;France
22	NCT01941095 (ClinicalTrials.gov)	November 20, 2013	30/8/2013	A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis	Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	100	Phase 3	Greece
23	NCT01768572 (ClinicalTrials.gov)	March 2013	11/1/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists	Rheumatoid Arthritis	Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	202	Phase 3	United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
24	NCT01709578 (ClinicalTrials.gov)	October 2012	15/10/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists	Rheumatoid Arthritis	Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	546	Phase 3	United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong
25	NCT02433184 (ClinicalTrials.gov)	July 2011	23/4/2015	Very Early Versus Delayed Etanercept in Patients With RA	A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine	University of Leeds	NULL	Completed	18 Years	80 Years	All	120	Phase 4	United Kingdom
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
26	NCT01132118 (ClinicalTrials.gov)	June 2010	25/5/2010	Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis	Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis	Rheumatoid Arthritis;Insulin Resistance	Drug: Hydroxychloroquine	Brigham and Women's Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	18 Years	N/A	All	30	Phase 3	United States
27	EUCTR2009-015740-42-DE (EUCTR)	12/05/2010	12/01/2010	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Metex 2,5mg INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Metex 2,5mg	Universitätsklinkum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3	Germany
28	NCT00405275 (ClinicalTrials.gov)	July 2007	29/11/2006	Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy	CSP #551 - Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy	Rheumatoid Arthritis	Drug: Etanercept;Drug: methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Placebo, triple;Drug: Placebo, etanercept	VA Office of Research and Development	Canadian Institutes of Health Research (CIHR);Rheumatoid Arthritis Investigational Network (RAIN);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	18 Years	N/A	All	353	N/A	United States;Canada
29	NCT00422227 (ClinicalTrials.gov)	June 2007	11/1/2007	Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region	A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	70 Years	All	300	Phase 4	Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
30	EUCTR2007-001190-28-GB (EUCTR)	09/05/2007	17/04/2007	Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT	Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: Sulfasalazine Product Code: Sulfasalazine INN or Proposed INN: SULFASALAZINE Product Name: Hydroxychloroquine Product Code: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Product Name: Ciclosporin Product Code: Ciclosporin INN or Proposed INN: Ciclosporin Product Name: Leflunomide Product Code: Leflunomide INN or Proposed INN: Leflunomide Product Name: Sodium aurothiomalate (intramuscular gold) Product Code: Sodium aurothiomalate (intramuscular gold) INN or Proposed INN: Sodium aurothiomalate Product Name: methylprednisolone Product Code: methylprednisolone INN or Proposed INN: Methylprednisolone Product Name: Prednisolone Product Code: Predniso	King's College London	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 4	United Kingdom
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
31	EUCTR2006-006186-16-NL (EUCTR)	30/01/2007	16/07/2007	IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED	IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED	rheumatoid arthritis and undifferentiated arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Methotrexate Product Code: MTX INN or Proposed INN: METHOTREXATE Product Name: Prednisone INN or Proposed INN: PREDNISONE Product Name: Sulfasalazine INN or Proposed INN: SULFASALAZINE Trade Name: hydroxychloroquine Product Name: hydroxychloroquine Product Code: HCQ INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE Trade Name: Humira Product Name: adalimumab	Leiden University Medical Center, department of rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
32	EUCTR2004-002006-30-GB (EUCTR)	17/11/2004	17/02/2005	Triple therapy in early active rheumatoid arthritis - TEAR	Triple therapy in early active rheumatoid arthritis - TEAR	Rheumatoid arthritis	Product Name: Methotrexate INN or Proposed INN: Methotrexate Trade Name: Salazopyrin En-Tabs Product Name: sulfasalazine INN or Proposed INN: Sulfasalazine Trade Name: Plaquenil Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine	North Glasgow NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	96		United Kingdom
33	NCT00089921 (ClinicalTrials.gov)	July 2004	17/8/2004	SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate	A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine	Arthritis, Rheumatoid	Drug: SCIO-469;Drug: Placebo	Scios, Inc.	NULL	Completed	18 Years	N/A	Both	302	Phase 2	United States
34	NCT00259610 (ClinicalTrials.gov)	May 2004	28/11/2005	Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)	Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)	Rheumatoid Arthritis	Drug: methotrexate;Drug: sulfasalazine;Drug: hydroxychloroquine;Drug: etanercept	University of Alabama at Birmingham	Amgen;Barr Laboratories;Pfizer	Completed	18 Years	N/A	All	755	Phase 4	United States
35	NCT00579878 (ClinicalTrials.gov)	December 1999	17/12/2007	Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis	Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-Hydroxychloroquine	University of Nebraska	NULL	Completed	19 Years	80 Years	All	69	Phase 3	United States

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

NCT04569890
(ClinicalTrials.gov)

December 1, 2020

20/9/2020

Treatment of Pregnancy RA

Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China

Rheumatoid Arthritis;Pregnancy Related

Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone

RenJi Hospital

NULL

Not yet recruiting

20 Years

40 Years

Female

100

N/A

China

NCT04347798
(ClinicalTrials.gov)

September 2020

13/4/2020

IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT

IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT

Covid-19 Infection;Rheumatoid Arthritis;Psoriatic Arthritis;Hydroxychloroquine

Other: Hydroxychloroquine/Chloroquine

University of Alberta

NULL

Enrolling by invitation

18 Years

N/A

All

500

Canada

NCT04389320
(ClinicalTrials.gov)

March 15, 2020

11/5/2020

Antimalarial and Covid 19 in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Hydroxychloroquine

Assiut University

NULL

Completed

20 Years

70 Years

All

Egypt

ChiCTR2000032534

2019-05-15

2020-05-01

Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study

Rheumatoid arthritis

Experimental group:Anbainuo plus methotrexate;Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine;

The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.

NULL

Completed

Both

Experimental group:47;Control group:43;

Phase 4

China

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

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

NCT03449758
(ClinicalTrials.gov)

March 5, 2018

8/2/2018

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors

Rheumatoid Arthritis

Drug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

Phase 4

France

JPRN-jRCTs031180050

26/12/2017

07/12/2018

Hydroxychloroquine for Japanese patients with rheumatoid arthritis

Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis

Rheumatoid arthritis;D001172

Treatment with hydroxychloroquine for 24 weeks

Kaneko Yuko

NULL

Recruiting

>= 18age old

Not applicable

Both

120

Japan

NCT03085940
(ClinicalTrials.gov)

January 20, 2017

7/2/2017

Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Hydroxychloroquine;Drug: Placebo

Indonesia University

NULL

Completed

18 Years

N/A

All

N/A

Indonesia

NCT02930343
(ClinicalTrials.gov)

September 2016

13/9/2016

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

65 Years

All

136

Phase 3

India

NCT02603146
(ClinicalTrials.gov)

April 27, 2016

10/11/2015

Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis

Healthy Participants;Rheumatoid Arthritis (RA) Prevention

Drug: Hydroxychloroquine;Drug: HCQ Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Recruiting

18 Years

N/A

All

200

Phase 2

United States

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

NCT02714634
(ClinicalTrials.gov)

March 2016

1/2/2016

Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

Randomized Controlled Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

Rheumatoid Arthritis;Insufficient Response to Methotrexate.

Drug: Methotrexate + biologic administration;Drug: methotrexate + salazopyrine + hydroxychloroquine administration

University Hospital, Strasbourg, France

NULL

Not yet recruiting

18 Years

N/A

Both

286

Phase 4

NULL

NCT02644499
(ClinicalTrials.gov)

December 31, 2015

30/12/2015

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

N/A

All

186

Phase 4

India

NCT02320630
(ClinicalTrials.gov)

October 2015

16/12/2014

Combination Therapy Prevents the Relapse of RA

The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity

Recurrence (Disease Attribute)

Drug: Entanercept;Drug: HCQ;Drug: MTX

Peking University First Hospital

Peking University People's Hospital;Peking University Third Hospital;Beijing Hospital;Beijing Jishuitan Hospital;Peking University Shougang Hospital;Beijing Shijitan Hospital

Recruiting

18 Years

70 Years

All

240

N/A

China

NCT02451748
(ClinicalTrials.gov)

August 2015

6/5/2015

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA

Rheumatoid Arthritis

Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira

University of Illinois at Chicago

UCB Pharma

Completed

18 Years

N/A

All

Phase 4

United States

EUCTR2014-005418-45-SE
(EUCTR)

04/05/2015

18/03/2015

Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)

Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE

Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE

Christine Bengtsson

Solveig Wållberg-Jonsson

Not Recruiting

Female: yes
Male: yes

Phase 2

Sweden

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

EUCTR2011-004720-35-NO
(EUCTR)

04/05/2015

26/01/2015

A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.

Rheumatoid arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Metex
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Imurel
INN or Proposed INN: IMUREL
Other descriptive name: AZATHIOPRINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
INN or Proposed INN: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: Plaquenil
Other descriptive name: HYDROXYCHLOROQUINE SULFATE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Norway;Sweden

NCT02466581
(ClinicalTrials.gov)

February 3, 2015

29/5/2015

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity

Rheumatoid Arthritis

Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

Phase 4

Sweden

EUCTR2011-004720-35-FI
(EUCTR)

10/09/2014

09/09/2014

Rheumatoid arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: METHOTREXATE DISODIUM
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Oxiklorin
Product Code: 118-42-3
Other descriptive name: HYDROXYCHLOROQUINE SULFATE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland;Denmark;Sweden

ChiCTR1900026116

2014-06-01

2019-09-22

The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial

rheumatoid arthritis

Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine;

Central Hospital of Jinhua

NULL

Completed

Both

Experimental group:40;control group:40;

Phase 4

China

ChiCTR-TRC-14004520

2014-05-01

2014-04-13

To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water

rheumatoid arthritis

two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA;

General Hospital of Chengdu Military Region

NULL

Recruiting

Both

two:240;RA patients:40;

I (Phase 1 study)

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
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Secondary_
sponsor

Recruitment_
Status

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agemin

Inclusion_
agemax

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Countries

NCT02057250
(ClinicalTrials.gov)

March 2014

31/1/2014

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy

Drug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Hydroxychloroquine

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

217

Phase 3

United States;Chile;Mexico;Poland;Russian Federation;South Africa;France

NCT01941095
(ClinicalTrials.gov)

November 20, 2013

30/8/2013

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

100

Phase 3

Greece

NCT01768572
(ClinicalTrials.gov)

March 2013

11/1/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

Rheumatoid Arthritis

Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

202

Phase 3

United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic

NCT01709578
(ClinicalTrials.gov)

October 2012

15/10/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists

Rheumatoid Arthritis

Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

546

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong

NCT02433184
(ClinicalTrials.gov)

July 2011

23/4/2015

Very Early Versus Delayed Etanercept in Patients With RA

A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine

University of Leeds

NULL

Completed

18 Years

80 Years

All

120

Phase 4

United Kingdom

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

NCT01132118
(ClinicalTrials.gov)

June 2010

25/5/2010

Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis

Rheumatoid Arthritis;Insulin Resistance

Drug: Hydroxychloroquine

Brigham and Women's Hospital

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Completed

18 Years

N/A

All

Phase 3

United States

EUCTR2009-015740-42-DE
(EUCTR)

12/05/2010

12/01/2010

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Prednisolon
Product Code: Prednisolon
INN or Proposed INN: PREDNISOLONE
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
Other descriptive name: AZATHIOPRINE
Trade Name: Immunosporin
Product Name: Immunosporin
INN or Proposed INN: CICLOSPORIN
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: GOLIMUMAB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Product Name: Quensyl
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: REMICADE
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Lantarel
Product Name: Lantarel
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Lantarel
Trade Name: Arava
Product Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Metex 2,5mg
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Metex 2,5mg

Universitätsklinkum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany

NCT00405275
(ClinicalTrials.gov)

July 2007

29/11/2006

Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

CSP #551 - Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Etanercept;Drug: methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Placebo, triple;Drug: Placebo, etanercept

VA Office of Research and Development

Canadian Institutes of Health Research (CIHR);Rheumatoid Arthritis Investigational Network (RAIN);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Completed

18 Years

N/A

All

353

N/A

United States;Canada

NCT00422227
(ClinicalTrials.gov)

June 2007

11/1/2007

Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

70 Years

All

300

Phase 4

Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand

EUCTR2007-001190-28-GB
(EUCTR)

09/05/2007

17/04/2007

Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: Sulfasalazine
Product Code: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Product Name: Hydroxychloroquine
Product Code: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine
Product Name: Ciclosporin
Product Code: Ciclosporin
INN or Proposed INN: Ciclosporin
Product Name: Leflunomide
Product Code: Leflunomide
INN or Proposed INN: Leflunomide
Product Name: Sodium aurothiomalate (intramuscular gold)
Product Code: Sodium aurothiomalate (intramuscular gold)
INN or Proposed INN: Sodium aurothiomalate
Product Name: methylprednisolone
Product Code: methylprednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Prednisolone
Product Code: Predniso

King's College London

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 4

United Kingdom

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

EUCTR2006-006186-16-NL
(EUCTR)

30/01/2007

16/07/2007

IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED

rheumatoid arthritis and undifferentiated arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Methotrexate
Product Code: MTX
INN or Proposed INN: METHOTREXATE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Product Name: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Trade Name: hydroxychloroquine
Product Name: hydroxychloroquine
Product Code: HCQ
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
Trade Name: Humira
Product Name: adalimumab

Leiden University Medical Center, department of rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

EUCTR2004-002006-30-GB
(EUCTR)

17/11/2004

17/02/2005

Triple therapy in early active rheumatoid arthritis - TEAR

Rheumatoid arthritis

Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Salazopyrin En-Tabs
Product Name: sulfasalazine
INN or Proposed INN: Sulfasalazine
Trade Name: Plaquenil
Product Name: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine

North Glasgow NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

NCT00089921
(ClinicalTrials.gov)

July 2004

17/8/2004

SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine

Arthritis, Rheumatoid

Drug: SCIO-469;Drug: Placebo

Scios, Inc.

NULL

Completed

18 Years

N/A

Both

302

Phase 2

United States

NCT00259610
(ClinicalTrials.gov)

May 2004

28/11/2005

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Rheumatoid Arthritis

Drug: methotrexate;Drug: sulfasalazine;Drug: hydroxychloroquine;Drug: etanercept

University of Alabama at Birmingham

Amgen;Barr Laboratories;Pfizer

Completed

18 Years

N/A

All

755

Phase 4

United States

NCT00579878
(ClinicalTrials.gov)

December 1999

17/12/2007

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-Hydroxychloroquine

University of Nebraska

NULL

Completed

19 Years

80 Years

All

Phase 3

United States

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	NCT03540810 (ClinicalTrials.gov)	August 15, 2018	27/4/2018	Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome	Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome	Primary Antiphospholipid Syndrome	Drug: Hydroxychloroquine;Drug: Placebo	University Hospital, Angers	NULL	Not yet recruiting	18 Years	N/A	All	300	Phase 3	France
2	NCT04153201 (ClinicalTrials.gov)	January 15, 2013	21/10/2019	Hydroxychloroquine for Thrombosis Prevention and Antiphospholipid Antibody Reduction in Primary Antiphospholipid Syndrome	Effect of Hydroxychloroquine on Thrombosis Prevention and Antiphospholipid Antibody Levels in Patients With Primary Antiphospholipid Syndrome: An Pilot Randomized Prospective Study.	Antiphospholipid Syndrome	Drug: Hydroxychloroquine	National and Kapodistrian University of Athens	NULL	Completed	18 Years	N/A	All	50	N/A	Greece

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	ChiCTR1900022934	2019-06-20	2019-05-04	Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin	Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin	Systemic Lupus Erythematosus	Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing;	Nanjing University of Chinese Medicine Affiliated Hospital	NULL	Pending			Both	Experimental group:20;control group:20;healthy control group:20;	Phase 1	China
2	ChiCTR1800020286	2019-02-01	2018-12-22	Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus	Efficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation	Systemic Lupus Erythematosus	Group 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;	Nanjing University of Chinese Medicine Affiliated Hospital	NULL	Pending			Both	Group 2:40;Group 1:20;	I (Phase 1 study)	China
3	ChiCTR1800019308	2018-11-12	2018-11-04	Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus	Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus	systemic lupus erythematosus	NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l);	The Third Affiliated Hospital, Southern Medical University	NULL	Recruiting	18	65	Both	NHMX:75;control:75;		China
4	NCT03030118 (ClinicalTrials.gov)	December 28, 2017	15/1/2017	Study of Anti-Malarials in Incomplete Lupus Erythematosus	Study of Anti-Malarials in Incomplete Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule	Milton S. Hershey Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Recruiting	15 Years	49 Years	All	240	Phase 2	United States
5	NCT03122431 (ClinicalTrials.gov)	June 5, 2017	17/4/2017	Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases	Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects	Systemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous Lupus	Drug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: Hydroxychloroquine high	University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo	Recruiting	5 Years	64 Years	All	296	Phase 4	Brazil
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	ChiCTR-INR-17011495	2017-05-25	2017-05-26	The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus	The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus	Primary mild to moderate systemic systemic lupus erythematosus	Immunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.;	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	NULL	Recruiting			Both	Immunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30;		China
7	ChiCTR-ONC-15007547	2015-12-05	2015-12-04	Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort study	Study of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus	systemic lupus erythematosus	The combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide);	Zhejiang Chinese Medical University	NULL	Recruiting	18	60	Both	The combination of Chinese and western group:264;Treating by Western Medicine group:264;		China
8	NCT02444728 (ClinicalTrials.gov)	July 2015	12/5/2015	Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE	Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus	Thrombocytopenia	Drug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: Methylprednisolone	Chinese SLE Treatment And Research Group	Peking Union Medical College Hospital	Recruiting	18 Years	70 Years	All	220	Phase 3	China
9	EUCTR2014-005418-45-SE (EUCTR)	04/05/2015	18/03/2015	Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)	Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE	Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE	Christine Bengtsson	Solveig Wållberg-Jonsson	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
10	JPRN-UMIN000012478	2014/04/01	01/01/2014	Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus	Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosus	systemic lupus erythematosuscutaneous lupus erythematosus	Treatment with Hydroxychloroquine	Department of Internal Medicine, Teikyo University School of Medicine	NULL	Recruiting	Not applicable	Not applicable	Male and Female	10	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
11	NCT01946880 (ClinicalTrials.gov)	November 20, 2013	13/9/2013	Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)	An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus;SLE	Drug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: Prednisone	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.	Terminated	18 Years	70 Years	All	102	Phase 2	United States
12	ChiCTR-TRC-12002419	2012-09-01	2012-08-01	The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients	The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients	systemic lupus erythematosus	1:Background treatment( - hydroxychloroquine );2:Background treatment( + hydroxychloroquine );3:Background treatment + hydroxychloroquine + Metformin;	Renji Hospital, Shanghai JiaoTong University School of Medicine	NULL	Completed	18	70	Both	1:60;2:60;3:60;		China
13	NCT01551069 (ClinicalTrials.gov)	March 2012	8/3/2012	Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion	A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion	Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus	Drug: hydroxychloroquine (Z0188);Drug: Placebo	Sanofi	NULL	Completed	18 Years	N/A	Both	103	Phase 3	Japan
14	NCT00413361 (ClinicalTrials.gov)	June 2007	18/12/2006	The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS	Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective Study	Systemic Lupus Erythematosus	Drug: versus hydroxychloroquine	Assistance Publique - Hôpitaux de Paris	Sanofi-Synthelabo	Completed	18 Years	N/A	Both	543	Phase 4	France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

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Status

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agemin

Inclusion_
agemax

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Phase

Countries

ChiCTR1900022934

2019-06-20

2019-05-04

Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin

Systemic Lupus Erythematosus

Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing;

Nanjing University of Chinese Medicine Affiliated Hospital

NULL

Pending

Both

Experimental group:20;control group:20;healthy control group:20;

Phase 1

China

ChiCTR1800020286

2019-02-01

2018-12-22

Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus

Efficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation

Systemic Lupus Erythematosus

Group 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;

Nanjing University of Chinese Medicine Affiliated Hospital

NULL

Pending

Both

Group 2:40;Group 1:20;

I (Phase 1 study)

China

ChiCTR1800019308

2018-11-12

2018-11-04

Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus

systemic lupus erythematosus

NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l);

The Third Affiliated Hospital, Southern Medical University

NULL

Recruiting

Both

NHMX:75;control:75;

China

NCT03030118
(ClinicalTrials.gov)

December 28, 2017

15/1/2017

Study of Anti-Malarials in Incomplete Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule

Milton S. Hershey Medical Center

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruiting

15 Years

49 Years

All

240

Phase 2

United States

NCT03122431
(ClinicalTrials.gov)

June 5, 2017

17/4/2017

Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases

Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects

Systemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous Lupus

Drug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: Hydroxychloroquine high

University of Sao Paulo General Hospital

Fundação de Amparo à Pesquisa do Estado de São Paulo

Recruiting

5 Years

64 Years

All

296

Phase 4

Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

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Intervention

Primary_
sponsor

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Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
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size

Phase

Countries

ChiCTR-INR-17011495

2017-05-25

2017-05-26

The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus

Primary mild to moderate systemic systemic lupus erythematosus

Immunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.;

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

NULL

Recruiting

Both

Immunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30;

China

ChiCTR-ONC-15007547

2015-12-05

2015-12-04

Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort study

Study of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus

systemic lupus erythematosus

The combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide);

Zhejiang Chinese Medical University

NULL

Recruiting

Both

The combination of Chinese and western group:264;Treating by Western Medicine group:264;

China

NCT02444728
(ClinicalTrials.gov)

July 2015

12/5/2015

Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus

Thrombocytopenia

Drug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: Methylprednisolone

Chinese SLE Treatment And Research Group

Peking Union Medical College Hospital

Recruiting

18 Years

70 Years

All

220

Phase 3

China

EUCTR2014-005418-45-SE
(EUCTR)

04/05/2015

18/03/2015

Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE

Christine Bengtsson

Solveig Wållberg-Jonsson

Not Recruiting

Female: yes
Male: yes

Phase 2

Sweden

JPRN-UMIN000012478

2014/04/01

01/01/2014

Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus

Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosus

systemic lupus erythematosuscutaneous lupus erythematosus

Treatment with Hydroxychloroquine

Department of Internal Medicine, Teikyo University School of Medicine

NULL

Recruiting

Not applicable

Male and Female

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

NCT01946880
(ClinicalTrials.gov)

November 20, 2013

13/9/2013

Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)

An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus;SLE

Drug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: Prednisone

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.

Terminated

18 Years

70 Years

All

102

Phase 2

United States

ChiCTR-TRC-12002419

2012-09-01

2012-08-01

The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients

systemic lupus erythematosus

1:Background treatment( - hydroxychloroquine );2:Background treatment( + hydroxychloroquine );3:Background treatment + hydroxychloroquine + Metformin;

Renji Hospital, Shanghai JiaoTong University School of Medicine

NULL

Completed

Both

1:60;2:60;3:60;

China

NCT01551069
(ClinicalTrials.gov)

March 2012

8/3/2012

Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion

Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Drug: hydroxychloroquine (Z0188);Drug: Placebo

Sanofi

NULL

Completed

18 Years

N/A

Both

103

Phase 3

Japan

NCT00413361
(ClinicalTrials.gov)

June 2007

18/12/2006

The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS

Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective Study

Systemic Lupus Erythematosus

Drug: versus hydroxychloroquine

Assistance Publique - Hôpitaux de Paris

Sanofi-Synthelabo

Completed

18 Years

N/A

Both

543

Phase 4

France

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	ChiCTR2000037989	2020-09-08	2020-09-08	Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial	Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial	primary Sjogren's syndrome	experimental group:Bushen Qingre Runzao Decoction 200ml bid po;control group:Hydroxychloroquine sulfate tablets 200ml bid po;	China-Japan Friendship Hospital	NULL	Recruiting	18	75	Both	experimental group:48;control group:48;	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	ChiCTR1800014623	2018-02-01	2018-01-24	A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome	A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome	Sjogren Syndrome	stem cell group: Intravenous use mesenchymal stem cell ;hydroxychloroquine group:oral use hydroxychloroquine ;	Tongji Hospital of Tongji University	NULL	Recruiting			Both	stem cell group:20;hydroxychloroquine group:20;		China
4	EUCTR2014-003140-12-NL (EUCTR)	21/09/2015	26/08/2015	Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome	Optimizing DMARD-therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome - LEF-HCQ combination therapy in pSS	Sjogren's Syndrome MedDRA version: 18.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Leflunomide Mylan Product Name: Leflunomide mylan INN or Proposed INN: LEFLUNOMIDE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE	UMC Utrecht	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no			Netherlands
5	ChiCTR-IPR-14005441	2014-01-01	2014-08-10	A double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndrome	A double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndrome	primary Sjogren syndrome	treatment group:hydroxychloroquine+Jiedu Tongluo Shengjin Decoction;	Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine	NULL	Recruiting	18	65	Both	treatment group:30;	I (Phase 1 study)	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
6	NCT01601028 (ClinicalTrials.gov)	July 2011	29/4/2012	Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome	Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome	Autoimmune Diseases;Sjogren's Syndrome;Dry Eye	Drug: Hydroxychloroquine;Drug: Placebo	Seoul National University Hospital	NULL	Completed	19 Years	N/A	Both	39	Phase 3	Korea, Republic of
7	JPRN-UMIN000004477	2010/11/01	01/11/2010	Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk		Systemic/cutaneous lupus erythematosusSjogren's syndrome	Hydroxychloroquine 200 mg will be administrated once daily. If insufficient, dosage can be escalated to 400 mg twice daily, but not exceed 6.5 mg/kg/day.	Kanazawa University Graduate School of Medical Science	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	10	Not applicable	Japan
8	NCT00632866 (ClinicalTrials.gov)	March 2008	29/2/2008	Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome	Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome	Primary Sjögren's Syndrome	Drug: Hydroxychloroquine;Drug: Placebo	Assistance Publique - Hôpitaux de Paris	Sanofi	Completed	18 Years	N/A	Both	120	Phase 3	France
9	NCT00873496 (ClinicalTrials.gov)	January 2005	31/3/2009	Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients	Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.	Sjögren's Syndrome;Xerostomia	Drug: Hydroxychloroquine	Ege University	NULL	Completed	N/A	N/A	Female	30	N/A	Turkey

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	NCT02942381 (ClinicalTrials.gov)	September 13, 2016	14/10/2016	A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy		IgA Patients;Hydroxychloroquine	Drug: Hydroxychloroquine Sulfate;Drug: Placebo	Peking University First Hospital	NULL	Completed	18 Years	75 Years	All	60	Phase 2	China
2	NCT02765594 (ClinicalTrials.gov)	June 2016	30/4/2016	Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy	Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study	Primary IgA Nephropathy	Drug: Hydroxychloroquine Sulfate;Drug: Valsartan	Peking Union Medical College Hospital	NULL	Recruiting	18 Years	60 Years	All	98	Phase 4	China
3	NCT02351752 (ClinicalTrials.gov)	January 2015	27/1/2015	Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study	Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease	Primary IgA Nephropathy	Drug: Hydroxychloroquine Sulfate	LLiu	NULL	Completed	18 Years	75 Years	Both	20	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
1	NCT02200146 (ClinicalTrials.gov)	March 2009	10/7/2014	Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS).	Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial.	Pulmonary Sarcoidosis	Drug: Prednisone;Drug: Hydroxychloroquine + Prednisone	University of Milano Bicocca	Agenzia Italiana del Farmaco	Completed	18 Years	70 Years	Both	94	Phase 3	Italy
2	EUCTR2008-001340-39-IT (EUCTR)	30/06/2008	13/06/2008	Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSAS	Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSAS	Pulmonary Sarcoidosis	Trade Name: PLAQUENIL25CPR RIV 200MG INN or Proposed INN: Hydroxychloroquine Trade Name: DELTACORTENE10CPR 25MG INN or Proposed INN: Prednisone	UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy