Hydroxychloroquine Sulfate ( DrugBank: Hydroxychloroquine, Sulfate )


4 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1
46悪性関節リウマチ7
53シェーグレン症候群6
66IgA腎症3

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-003170-23-FI
(EUCTR)
20/12/202230/09/2022Hydroxychloroquine in progressive MSProspective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS) Progressive multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Oxiklorin
Product Name: Oxiklorin
INN or Proposed INN: Hydroxychloroquine sulfate
Varsinais-Suomen sairaanhoitopiirin kuntayhtymäNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Finland

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004720-35-NO
(EUCTR)
04/05/201526/01/2015A 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Sweden
2EUCTR2011-004720-35-FI
(EUCTR)
10/09/201409/09/2014A 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland;Denmark;Sweden
3ChiCTR-TRC-14004520
2014-05-012014-04-13To 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 waterTo 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 arthritistwo: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 RegionNULLRecruiting4565Bothtwo:240;RA patients:40;I (Phase 1 study)China
4EUCTR2013-003658-26-NL
(EUCTR)
13/11/201318/10/2013Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Prednison
Product Name: Prednison
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Plaquenil
Product Name: hydroxycholoquine
INN or Proposed INN: hydroxychloroquine sulfate
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: Sulfasalazine
Product Name: Sulfasalazine
INN or Proposed INN: Sulfasalazine
Other descriptive name: SULFASALAZINE
VU University Medical CenterNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
5EUCTR2009-015740-42-DE
(EUCTR)
12/05/201012/01/2010A 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 - RETROA 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: A
Universitätsklinkum ErlangenNULLNot RecruitingFemale: yes
Male: yes
318Phase 3Germany
6ChiCTR2100043373
2009-07-012021-02-12Clinical study of Hydroxychloroquine Sulfate and sulfasalazine in the treatment of active rheumatoid arthritisClinical study of Hydroxychloroquine Sulfate and sulfasalazine in the treatment of active rheumatoid arthritis rheumatoid arthritisgroup one:HCQ(200mg/d)+MTX;group two:HCQ(400mg/d)+MTX;group three:HCQ(200mg/d)+SASP+MTX;group four:SASP+MTX;Renji Hospital, Shanghai Jiaotong University School of MedicineNULLCompletedBothgroup one:50;group two:50;group three:50;group four:50;Phase 4china
7EUCTR2006-006186-16-NL
(EUCTR)
30/01/200716/07/2007IMPROVED: 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 - IMPROVEDIMPROVED: 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 rheumatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002470-32-NL
(EUCTR)
12/12/202223/07/2021NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patientsNEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY Primary Sjögren’s syndrome (pSS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PLAQUENIL
Product Name: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: Mycophenolate mofetil TEVA
Product Name: mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil
Other descriptive name: MYCOPHENOLATE MOFETIL
Trade Name: Arava
Product Name: Leflunomide
INN or Proposed INN: LEFLUNOMIDE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Netherlands;Italy
2ChiCTR2200057578
2022-03-012022-03-15Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trialTofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial Sjogren SyndromeControl group:Same dose of hydroxychloroquine sulfate as before;Intervention group:Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before;Ningbo Medical Center Lihuili HospitalNULLPending1570BothControl group:60;Intervention group:60;Phase 4China
3EUCTR2019-002470-32-NO
(EUCTR)
14/12/202126/08/2021NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patientsNEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY Primary Sjögren’s syndrome (pSS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PLAQUENIL
Product Name: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: Mycophenolate mofetil TEVA
Product Name: mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil
Other descriptive name: MYCOPHENOLATE MOFETIL
Trade Name: Arava
Product Name: Leflunomide
INN or Proposed INN: LEFLUNOMIDE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Netherlands;Norway;Italy
4EUCTR2019-002470-32-IT
(EUCTR)
05/10/202127/01/2022Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti.NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY Primary Sjögren's syndrome (pSS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Arava
Product Name: Leflunomide
Product Code: [Leflunomide]
INN or Proposed INN: LEFLUNOMIDE
Trade Name: Mycophenolate mofetil TEVA
Product Name: mycophenolate mofetil
Product Code: [mycophenolate mofetil]
INN or Proposed INN: MICOFENOLATO MOFETILE
Trade Name: PLAQUENIL
Product Name: Hydroxychloroquine
Product Code: [Hydroxychloroquine]
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
ASSITANCE PUBLIQUE DES HOPITAUX DE PARISNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;Greece;Spain;Norway;Netherlands;United Kingdom;Italy;Sweden
5ITMCTR2000003900
2020-09-082020-09-08Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trialBushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial Primary Sjogren's syndromeControl group:Hydroxychloroquine sulfate tablets 200ml bid po;Experimental group:Bushen Qingre Runzao Decoction 200ml bid po;China-Japan Friendship HospitalNULLRecruiting1875BothControl group:48;Experimental group:48;N/AChina
6ChiCTR2000037989
2020-09-082020-09-08Bushen 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 syndromeExperimental group:Bushen Qingre Runzao Decoction 200ml bid po;Control group:Hydroxychloroquine sulfate tablets 200ml bid po;China-Japan Friendship HospitalNULLRecruiting1875BothExperimental group:48;Control group:48;N/AChina

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02942381
(ClinicalTrials.gov)
September 13, 201614/10/2016A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA NephropathyIgA Patients;HydroxychloroquineDrug: Hydroxychloroquine Sulfate;Drug: PlaceboPeking University First HospitalNULLCompleted18 Years75 YearsAll60Phase 2China
2NCT02765594
(ClinicalTrials.gov)
June 201630/4/2016Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA NephropathyHydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled StudyPrimary IgA NephropathyDrug: Hydroxychloroquine Sulfate;Drug: ValsartanPeking Union Medical College HospitalNULLRecruiting18 Years60 YearsAll98Phase 4China
3NCT02351752
(ClinicalTrials.gov)
January 201527/1/2015Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled StudyRenal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal DiseasePrimary IgA NephropathyDrug: Hydroxychloroquine SulfateLLiuNULLCompleted18 Years75 YearsBoth20Phase 4China