ARAVA ( DrugBank: - )


3 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10
53シェーグレン症候群3
162類天疱瘡(後天性表皮水疱症を含む。)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
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
3EUCTR2012-005275-14-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
4EUCTR2009-015740-42-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
5EUCTR2008-007225-39-BE
(EUCTR)
06/01/200912/02/2009A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA early active Rheumatoid Arthritis, previously untreated with DMARDS
MedDRA version: 20.0;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: Ledertrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Salazopyrine
INN or Proposed INN: SULFASALAZINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
University Hospitals LeuvenNULLNot RecruitingFemale: yes
Male: yes
400Phase 4Belgium
6EUCTR2007-000886-40-IT
(EUCTR)
04/06/200821/03/2008Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
sanofi-aventis GroupeNULLNot RecruitingFemale: yes
Male: yes
200Portugal;Italy
7EUCTR2007-000886-40-PT
(EUCTR)
09/11/200707/08/2007Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
sanofi-aventis groupeNULLNot RecruitingFemale: yes
Male: yes
200Portugal;Italy
8EUCTR2007-000886-40-CZ
(EUCTR)
17/07/200730/05/2007Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
sanofi-aventis groupeNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Czech Republic;Italy
9EUCTR2005-004582-41-GB
(EUCTR)
24/03/200627/01/2006 Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA Active Rheumatoid ArthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: Rituximab
Trade Name: Arava
Product Name: Arava
Product Code: Leflunomide
Trade Name: Solu-Medrone 2 Gram
Product Name: Solu-Medrone 2mg
Product Code: Methylprednisolone
University of LeedsNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
10NCT00946686
(ClinicalTrials.gov)
September 200224/7/2009To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting ConditionsA Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting ConditionsRheumatoid Arthritis;Psoriatic ArthritisDrug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical);Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)SandozNULLCompleted18 YearsN/AAll52Phase 1NULL

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

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-003545-32-FR
(EUCTR)
14/09/200723/07/2007Etude prospective ouverte de l'efficacité du leflunomide dans le traitement de la pemphigoïde bulleuse en association aux dermocorticoïdes. - ARABULEtude prospective ouverte de l'efficacité du leflunomide dans le traitement de la pemphigoïde bulleuse en association aux dermocorticoïdes. - ARABUL Pemphigoïde bulleuse
MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid
Trade Name: ARAVA
Trade Name: DERMOVAL
CHU de LimogesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France