HCQ ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ9
49全身性エリテマトーデス4

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
1NCT02603146
(ClinicalTrials.gov)
April 27, 201610/11/2015Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid ArthritisStrategy to Prevent the Onset of Clinically-Apparent Rheumatoid ArthritisHealthy Participants;Rheumatoid Arthritis (RA) PreventionDrug: Hydroxychloroquine;Drug: HCQ PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 YearsN/AAll144Phase 2United States
2NCT03855007
(ClinicalTrials.gov)
January 1, 201615/2/2019The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months TreatmentProspective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in ChinaArthritis, RheumatoidDrug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: PredQilu Hospital of Shandong UniversityNULLActive, not recruiting16 Years90 YearsAll200Phase 4China
3NCT02320630
(ClinicalTrials.gov)
October 201516/12/2014Combination Therapy Prevents the Relapse of RAThe 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 ActivityRecurrence (Disease Attribute)Drug: Entanercept;Drug: HCQ;Drug: MTXPeking University First HospitalPeking University People's Hospital;Peking University Third Hospital;Beijing Hospital;Beijing Jishuitan Hospital;Peking University Shougang Hospital;Beijing Shijitan HospitalRecruiting18 Years70 YearsAll240N/AChina
4EUCTR2014-005418-45-SE
(EUCTR)
04/05/201518/03/2015Are 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 BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
5NCT02551575
(ClinicalTrials.gov)
November 201426/8/2015Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid ArthritisEfficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center TrialRheumatoid ArthritisDrug: Treatment of MTX and HCQ;Drug: Treatment of TCM;Drug: Integrative MedicineGuang'anmen Hospital of China Academy of Chinese Medical SciencesNULLActive, not recruiting18 Years65 YearsBoth468Phase 2/Phase 3China
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
7NCT00848354
(ClinicalTrials.gov)
June 200918/2/2009Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) TherapyA Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARDPfizerAmgenCompleted18 Years69 YearsAll429Phase 4Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela
8EUCTR2006-006186-16-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
9NCT00764725
(ClinicalTrials.gov)
December 20021/10/2008Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTXRheumatoid ArthritisDrug: conventional DMARD combination;Biological: MTX plus anti-TNFKarolinska InstitutetNULLCompleted18 YearsN/ABoth487Phase 4NULL

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs011190011
13/03/202013/03/2020Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosusSteroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study Systemic lupus erythematosus
Systemic lupus erhythematosus;D008180
Subjects who have met the entry criteria will be randomly to one of the two treatment groups based on a computer-generated randomization schedule as follows: 1) BEL group and 2) CS increased group using standard CS therapy (CS group) .

1. Subjects in BEL group will receive BEL 200 mg weekly SC on Day 0, and then every 7 days through week 24 or BEL 10mg/kg IV on Day 0, 14, 28 and every 1 month.
2. Subjects in CS group will receive prednisolone (All subjects will start treatment with MMF oral 1g/day
In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day).
In the BEL group, the baseline dose of CS
Atsumi TatsuyaNULLRecruiting>= 18age oldNot applicableBoth48Phase 4Japan
2NCT03122431
(ClinicalTrials.gov)
June 5, 201717/4/2017Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune DiseasesRelevance 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 EffectsSystemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous LupusDrug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: standard dose of HCQUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted5 Years64 YearsAll93Phase 4Brazil
3NCT02842814
(ClinicalTrials.gov)
October 20163/6/2016Prediction of Relapse Risk in Stable Systemic Lupus ErythematosusEvaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From ChinaSystemic Lupus ErythematosusOther: Drug free;Drug: HCQ;Drug: GC+HCQPeking Union Medical College HospitalXiangya Hospital of Central South University;Shengjing Hospital;People's Hospital of Xinjiang Uygur Autonomous Region;Anhui Provincial Hospital;Beijing HospitalCompleted18 Years60 YearsAll333N/AChina
4EUCTR2014-005418-45-SE
(EUCTR)
04/05/201518/03/2015Are 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 BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes
Phase 2Sweden