Plaquenil ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ6
49全身性エリテマトーデス1
53シェーグレン症候群6
96クローン病1

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
2EUCTR2014-005418-45-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
3EUCTR2013-003658-26-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
4EUCTR2012-005275-14-NO
(EUCTR)
19/03/201304/02/2013Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugsRemission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND Rheumatoid arthritis (RA)
MedDRA version: 15.1;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: Methotrexate Pfizer 2,5 mg tabletter
Trade Name: Methotrexate Pfizer 2,5 mg tabletter
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Trade Name: Salazopyrin EN 500 mg enterotabletter
Trade Name: Salazopyrin EN 500 mg enterotabletter
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Trade Name: Arava 20 mg filmdrasjerte tabletter
Trade Name: Arava 20 mg filmdrasjerte tabletter
Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning
Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning.
Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte
Diakonhjemmet Hospital ASNULLNot RecruitingFemale: yes
Male: yes
360Phase 4Norway
5EUCTR2006-001428-38-GB
(EUCTR)
18/09/200629/09/2006Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERARemission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)Trade Name: Enbrel
Trade Name: Methorexate
Trade Name: Depo-Medrone
Trade Name: Salazopyrin En-Tabs
Trade Name: Plaquenil
University Hospitals Birmingham NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
20Phase 4United Kingdom
6EUCTR2004-002006-30-GB
(EUCTR)
17/11/200417/02/2005Triple therapy in early active rheumatoid arthritis - TEARTriple therapy in early active rheumatoid arthritis - TEAR Rheumatoid arthritisProduct 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 TrustNULLNot RecruitingFemale: yes
Male: yes
96United Kingdom

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
1EUCTR2014-005418-45-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

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
2EUCTR2019-002470-32-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
3EUCTR2019-002470-32-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
4EUCTR2020-001933-11-NL
(EUCTR)
10/06/202104/06/2021Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome - RepurpSS-II study Primary Sjogren Syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Leflunomide
Product Name: Leflunomide
Trade Name: Plaquenil
Product Name: Hydroxychloroquine
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2Netherlands
5EUCTR2014-003140-12-NL
(EUCTR)
21/09/201526/08/2015Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's SyndromeOptimizing 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 UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
Netherlands
6EUCTR2007-005218-38-FR
(EUCTR)
31/01/200820/11/2007Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUEREssai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER Syndrome de Sjögren primitif
MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: Sulfate d'hydroxychloroquine
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-001137-99-GB
(EUCTR)
28/04/200927/11/2008 CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Ciprofloxacin
Product Code: PL 20532/0012
INN or Proposed INN: Ciprofloxacin hydrochloride
Product Name: Budesonide
Product Code: PL 17901/0122
INN or Proposed INN: Budesonide
Other descriptive name: Entocort CR
Trade Name: DOXYCYCLINE
Product Name: DOXYCYCLINE
INN or Proposed INN: DOXYCYCLINE HYCLATE
Other descriptive name: DOXYCYCLINE
Trade Name: HYDROXYCHLOROQUINE
Product Name: HYDROXYCHLOROQUINE SULPHATE
INN or Proposed INN: HYDROXYCHLOROQUINE SULPHATE
Other descriptive name: PLAQUENIL
Royal Liverpool & Broadgreen University Hospitals TrustUniversity of LiverpoolNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom