LEFLUNOMIDE ( DrugBank: Leflunomide )


12 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症1
40高安動脈炎2
46悪性関節リウマチ57
49全身性エリテマトーデス3
53シェーグレン症候群4
66IgA腎症3
107若年性特発性関節炎1
162類天疱瘡(後天性表皮水疱症を含む。)2
224紫斑病性腎炎1
270慢性再発性多発性骨髄炎1
271強直性脊椎炎1
300IgG4関連疾患1

11. 重症筋無力症


臨床試験数 : 315 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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agemin
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agemax
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gender
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PhaseCountries
1NCT01727193
(ClinicalTrials.gov)
September 20128/11/2012The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand ThymectomyMyasthenia GravisDrug: Azathioprine;Drug: LeflunomideFirst Affiliated Hospital, Sun Yat-Sen UniversityNULLRecruiting12 Years65 YearsAll158Phase 3China

40. 高安動脈炎


臨床試験数 : 25 薬物数 : 50 - (DrugBank : 21) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 114
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02981979
(ClinicalTrials.gov)
December 201622/11/2016Takayasu Arteritis Clinical Trial in ChinaComparison of the Efficacy and Safety of Leflunomide Versus Placebo Combine With the Basic Prednisone Therapy in Patients With Active Phase of Takayasu's Arteritis: a Randomized Controlled Double-blinded TrialTakayasu ArteritisDrug: Leflunomide 10mg Tab;Drug: Prednisone Acetate;Drug: PlacebosJiang lindiNULLUnknown status18 Years65 YearsAll116N/AChina
2NCT03893136
(ClinicalTrials.gov)
November 1, 201612/3/2019The Registry Study of Takayasu Arteritis in East ChinaThe Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)Takayasu Arteritis;Mechanisms, Defense;Pregnancy Related;Treatment Refusal;OutcomeBiological: Tocilizumab;Drug: LeflunomideShanghai Zhongshan HospitalNULLRecruiting18 Years65 YearsAll1000China

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100041777
2021-01-012021-01-05Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritisClinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis rheumatoid arthritisTreatment group:Juanbi granule, Prednisone Acetate Tablets, Methotrexate and Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate and Leflunomide;Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1865BothTreatment group:62;control group:31;China
2ChiCTR2100041819
2021-01-012021-01-06Clinical study of Hanbi ointment in the treatment of rheumatoid arthritisClinical study of Hanbi ointment in the treatment of rheumatoid arthritis Rheumatoid arthritisTreatment group:Hanbi ointment + Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;control group:Hanbi ointment simulant+ Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;The First Affiliated Hospital of Yunnan University of traditional Chinese MedicineNULLRecruitingBothTreatment group:36;control group:36;China
3ChiCTR2100041821
2021-01-012021-01-06Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint painObservation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain Rheumatoid Arthritistherapy group:Rebi ointment, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets ;Control group:Rebi cream simulant, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets;Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1870Boththerapy group:36;Control group:36;China
4ChiCTR2100041909
2021-01-012021-01-09Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome)Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) Rheumatoid arthritisTreatment group:Yupingfengguizhi solution, Prednisone Acetate Tablets, Methotrexate, Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate, Leflunomide;Yunnan Traditional Chinese Medicine HospitalNULLRecruiting1865BothTreatment group:62;control group:31;China
5ChiCTR2100041894
2021-01-012021-01-09Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and painObservation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain Rheumatoid arthritistherapy group:Yiyisise ointment, Methotrexate, Leflunomide tablets and Folic acid tablets ;Control group:Yiyisise ointment simulant, Methotrexate, Leflunomide tablets and Folic acid tablets;Yunnan Hospital of Traditional Chinese MedicineNULLRecruitingBoththerapy group:36;Control group:36;China
6NCT03649061
(ClinicalTrials.gov)
June 8, 201830/7/2018COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RAEffectiveness of a Combination of Methotrexate and a Step Down Glucocorticoid Regimen (COBRA-Slim) for Remission Induction in Patients With Early Rheumatoid Arthritis (RA), With or Without Fast Access to 24 Weeks of Tumor Necrosis Factor (TNF) Blockade in Insufficient Responders, a Randomized, Multicenter, Pragmatic TrialArthritis, RheumatoidDrug: Etanercept 50 MG/ML;Drug: Leflunomide 10 milligram (MG)P. VerschuerenBelgium Health Care Knowledge CentreActive, not recruiting18 YearsN/AAll284Phase 4Belgium
7EUCTR2017-004054-41-BE
(EUCTR)
07/05/201815/03/2018COBRA-Slim with or without fast access to TNF blockade for remission induction in early RACareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020 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]
Product Name: etanercept
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: LEFLUNOMIDE
University Hospitals LeuvenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
440 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesBelgium
8NCT03449758
(ClinicalTrials.gov)
March 5, 20188/2/2018Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid ArthritisEffect 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 InhibitorsRheumatoid ArthritisDrug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: SulfasalazineSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll84Phase 4France
9NCT04022525
(ClinicalTrials.gov)
February 1, 201815/7/2019Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic ApproachesAssessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic ApproachesRheumatoid ArthritisDrug: Leflunomide 20Mg TabAssiut UniversityNULLCompleted18 YearsN/AAll80Egypt
10EUCTR2011-004720-35-NL
(EUCTR)
22/03/201722/02/2017A 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: 19.1;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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
INN or Proposed INN: PREDNISOLONE
The Karolinska Institute, ClinTRIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Iceland;Netherlands;Sweden
11NCT02930343
(ClinicalTrials.gov)
September 201613/9/2016Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate MonotherapyComparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control TrialRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: SulfasalazineJawaharlal Institute of Postgraduate Medical Education & ResearchNULLTerminated18 Years65 YearsAll136Phase 3India
12NCT02878161
(ClinicalTrials.gov)
January 201612/7/2016Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real WorldScreening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal PathwayRheumatoid ArthritisDrug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)Fen LiNULLEnrolling by invitation18 Years75 YearsBoth240Phase 4NULL
13NCT02644499
(ClinicalTrials.gov)
December 31, 201530/12/2015Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid ArthritisComparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic AcidJawaharlal Institute of Postgraduate Medical Education & ResearchNULLCompleted18 YearsN/AAll186Phase 4India
14NCT02451748
(ClinicalTrials.gov)
August 20156/5/2015IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIAIL-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 CIMZIARheumatoid ArthritisOther: 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: humiraUniversity of Illinois at ChicagoUCB PharmaCompleted18 YearsN/AAll32Phase 4United States
15EUCTR2011-004720-35-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
16NCT02373202
(ClinicalTrials.gov)
February 201512/2/2015A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: MizoribineSanofiRegeneron PharmaceuticalsCompleted20 YearsN/AAll91Phase 3Japan
17EUCTR2014-002374-36-SE
(EUCTR)
19/11/201427/08/2014A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in 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 (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-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
Trade Name: Orencia
Trade Name: RoActemra
Trade Name: Methotrexate
Trade Name: Metoject
Trade Name: Azathioprine
Trade Name: Leflunomide
The Karolinska Institutet, ClinTRIDNULLNot RecruitingFemale: yes
Male: yes
500Phase 4Sweden
18EUCTR2011-004720-35-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
19EUCTR2011-004720-35-DK
(EUCTR)
28/05/201424/02/2014A 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: 19.1;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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Netherlands;Norway;Iceland;Sweden
20NCT02057250
(ClinicalTrials.gov)
March 201431/1/2014To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid ArthritisA 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 TherapyRADrug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: HydroxychloroquineSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll217Phase 3United States;Chile;Mexico;Poland;Russian Federation;South Africa;France
21NCT01941095
(ClinicalTrials.gov)
November 20, 201330/8/2013A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid ArthritisMulticenter, 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 ArthritisRheumatoid ArthritisDrug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll100Phase 3Greece
22NCT02275299
(ClinicalTrials.gov)
September 201323/10/2014Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid ArthritisA Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Iguratimod;Drug: Leflunomide;Drug: MethotrexateJiangsu Simcere Pharmaceutical Co., Ltd.NULLRecruiting18 Years70 YearsBoth240Phase 4China
23NCT01774877
(ClinicalTrials.gov)
July 201322/1/2013A Clinical Study of Xin'an Medicine in the Treatment of Bi SyndromeEfficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center TrialRheumatoid ArthritisDrug: Xinfeng capsule;Drug: leflunomideThe First Affiliated Hospital of Anhui University of Traditional Chinese MedicineMinistry of Science and Technology of the People´s Republic of ChinaCompleted18 Years65 YearsBoth304N/AChina
24NCT01768572
(ClinicalTrials.gov)
March 201311/1/2013To 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 AntagonistsRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placeboSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll202Phase 3United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
25ChiCTR-TRC-13003948
2013-01-012013-12-05The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney patternThe evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern rheumatoid arthritisControl:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ;Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese MedicineNULLCompleted1870BothControl:60;EA combined with medicine group:60;China
26NCT01749787
(ClinicalTrials.gov)
November 20126/12/2012Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid ArthritisA Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcgProtalex, Inc.NULLCompleted18 YearsN/ABoth61Phase 1United States
27NCT01619176
(ClinicalTrials.gov)
October 20125/6/2012Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and BloodNon Inferiority Trial for the Study of Acupuncture on Rheumatoid ArthritisRheumatoid ArthritisDrug: methotrexate;Drug: non-steroidal anti-inflammatory drug (NSAID);Drug: leflunomide;Procedure: AcupunctureChinese Academy of SciencesShanghai GuangHua Hospital of integrated traditional and western medicineCompleted18 Years65 YearsFemale15N/AChina
28NCT01709578
(ClinicalTrials.gov)
October 201215/10/2012To 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 AntagonistsRheumatoid ArthritisDrug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomideSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll546Phase 3United 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
29NCT01659242
(ClinicalTrials.gov)
July 20123/8/2012Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging StudyLeflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging StudyRheumatoid ArthritisDrug: Methotrexate plus sulfasalazine;Drug: LeflunomideSingapore General HospitalNULLTerminated21 Years65 YearsBoth1Phase 4Singapore
30EUCTR2011-004720-35-SE
(EUCTR)
28/05/201222/12/2011A 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: 14.1;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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
The Karolinska Institute, ClinTRIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Sweden
31NCT01617590
(ClinicalTrials.gov)
May 201228/5/2012Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy ResearchA 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: leflunomide;Drug: methotrexateShanxi Medical UniversityNULLRecruiting18 Years75 YearsBoth500N/AChina
32ChiCTR-TRC-12001859
2012-01-012012-01-04Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical researchTreatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research coronary heart disease in rheumatoid arthritis1:leflunomide combined with ligustrazine;2:leflunomide combined with placebo;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesNULLCompleted1865Both1:30;2:30;China
33ChiCTR-TRC-11001789
2011-11-142011-12-12Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocolEffect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol Rheumatoid ArthritisTreatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom;Control:methotrexate(MTX) + leflunomide (LEF);Anhui Provincial Hospital Department of RheumatismNULLCompleted1865BothTreatment:140;Control:140;China
34NCT01225393
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placeboGenentech, Inc.NULLCompleted18 Years75 YearsBoth211Phase 2Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
35ChiCTR-TRC-10001014
2010-09-012010-08-30Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood StasisRandomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis Rheumatoid Arthritis;M06.991Group A:observation group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. Ligustrazine Powder-Needle, 0.12g, solubling in 5% GS/NS 100ml, qd, iv, in 30 to 60 minutes. ;Group B:control group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. ;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical SciencesNULLCompleted1865BothGroup A:60;Group B:60;I (Phase 1 study)China
36NCT01244958
(ClinicalTrials.gov)
August 201028/9/2010Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid ArthritisAddition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis - a Multicenter Randomised Double-blind Clinical TrialRheumatoid ArthritisBiological: Rituximab;Drug: PlaceboFrank BehrensNULLCompleted18 Years75 YearsBoth156Phase 3Germany
37EUCTR2009-015950-39-DE
(EUCTR)
12/05/201028/12/2009Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritisAddition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
MedDRA version: 14.1;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: MabThera®
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Johann Wolfgang Goethe-Universität Frankfurt/M.NULLNot RecruitingFemale: yes
Male: yes
Germany
38EUCTR2009-015740-42-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
39ChiCTR-TRC-09000472
2009-07-202009-07-15Weekly dose of leflunomide for the treatment of early rheumatoid arthritisWeekly dose of leflunomide for the treatment of early rheumatoid arthritis: a multicentre, open, randomized clincal trial Rheumatoid arthritisGroup A:leflunomide 10mg,orally taken once daily for 24 weeks;Group B:leflunomide 50mg, orally taken weekly for 24 weeks;People's Hospital, Peking UniversityNULLCompleted1865BothGroup A:160;Group B:160;China
40ChiCTR-TRC-12003871
2009-05-012012-01-01Phase II of Tong Luo Hua Shi Capsules in Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Phase II Study Evaluating the Safety and Efficacy of Tong Luo Hua Shi Capsules in Participants with Rheumatoid Arthritis Rheumatoid arthritisA:2 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;B:3 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;C:4 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;D:4 pieces placebo;The First Teaching Hospital of Tianjin University of Traditional Chinese MedicineNULLCompleted1868BothA:60;B:60;C:60;D:60;I+2 (Phase 1+Phase 2)China
41NCT01172639
(ClinicalTrials.gov)
February 200928/7/2010Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: PrednisoneP. VerschuerenAgentschap voor Innovatie door Wetenschap en TechnologieCompleted18 YearsN/AAll400Phase 4Belgium
42EUCTR2008-007225-39-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
43EUCTR2007-000886-40-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
44NCT00596206
(ClinicalTrials.gov)
December 20074/1/2008Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid ArthritisAssessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-PatientsArthritis, RheumatoidDrug: leflunomideSanofiNULLCompleted18 YearsN/ABoth124Phase 3Czech Republic;Italy;Korea, Republic of;Portugal;Romania
45EUCTR2007-000886-40-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
46ChiCTR-TRC-11001755
2007-10-012011-12-01Phase II of Tu Fu Ling Tablets in Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Double-dummy, Phase II Study Evaluating the Safety and Efficacy of Tu Fu Ling Tablets in Participants with Rheumatoid Arthritis Rheumatoid ArthritisA:Tu Fu Ling Tablets, 200mg Bid. Other: Placebo;B:Tu Fu Ling Tablets, 100mg Tid. Other: Placebo. ;C:Leflunomide Tablets, 20mg Qd. Other: Placebo;The First Teaching Hospital of Tianjin University of Traditional Chinese MedicineNULLCompleted1865BothA:80;B:80;C:80;2 (Phase 2 study)China
47NCT03414502
(ClinicalTrials.gov)
August 20072/1/2014Treatment of Rheumatoid Arthritis With DMARDs: Predictors of ResponseTreatment of Rheumatoid Arthritis With DMARDs: Predictors of ResponseRheumatoid ArthritisDrug: Methotrexate;Drug: Abatacept;Drug: Adalimumab;Drug: Azathioprine;Drug: Baricitinib;Drug: Certolizumab;Drug: Etanercept;Drug: Golimumab;Drug: Hydroxychloroquine;Drug: Infliximab;Drug: Leflunomide;Drug: Minocycline;Drug: Rituximab;Drug: Sarilumab;Drug: Sulfasalazine;Drug: TofacitinibUniversity of NebraskaNULLRecruiting19 YearsN/AAll400Phase 3United States
48EUCTR2007-000886-40-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
49NCT00422227
(ClinicalTrials.gov)
June 200711/1/2007Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific RegionA Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomideWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll300Phase 4Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
50NCT00476996
(ClinicalTrials.gov)
May 15, 200718/5/2007A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-a Therapy (SCRIPT)A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-a TherapyRheumatoid ArthritisDrug: Leflunomide;Drug: Methotrexate;Drug: Ocrelizumab;Drug: PlaceboGenentech, Inc.Roche Pharma AGTerminated18 YearsN/AAll836Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Netherlands;New Zealand;Panama;Peru;Poland;Slovakia;Slovenia;Spain;Sweden;Switzerland;Taiwan
51EUCTR2007-001190-28-GB
(EUCTR)
09/05/200717/04/2007Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACITRandomised 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 LondonNULLNot RecruitingFemale: yes
Male: yes
190Phase 4United Kingdom
52EUCTR2005-004582-41-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
53NCT00280644
(ClinicalTrials.gov)
April 200419/1/2006Leflunomide in Rheumatoid ArthritisEfficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) PatientsArthritis, RheumatoidDrug: LeflunomideSanofiNULLCompleted18 Years75 YearsBoth60Phase 4Turkey
54NCT00563849
(ClinicalTrials.gov)
May 200321/11/2007Leflunomide + Methotrexate in Rheumatoid ArthritisAn Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.Rheumatoid ArthritisDrug: LeflunomideSanofiNULLCompleted18 Years75 YearsBoth74Phase 4Korea, Republic of
55NCT00946686
(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
56NCT00451971
(ClinicalTrials.gov)
March 200223/3/2007Objective Study in Rheumatoid ArthritisObjective Study in Rheumatoid ArthritisArthritis, RheumatoidDrug: LEFLUNOMIDESanofiNULLCompleted18 Years75 YearsBoth249Phase 4Australia
57NCT00579878
(ClinicalTrials.gov)
December 199917/12/2007Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid ArthritisTriple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-HydroxychloroquineUniversity of NebraskaNULLCompleted19 Years80 YearsAll69Phase 3United States

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR-INR-17011495
2017-05-252017-05-26Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic syThe 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 erythematosusImmunomodulatory 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 TechnologyNULLRecruitingBothImmunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30;China
2NCT00230035
(ClinicalTrials.gov)
September 200528/9/2005Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus ErythematosusSystemic Lupus ErythematosusProcedure: Leukapheresis;Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT);Procedure: Autologous CD34+HPC transplantation (HSCT);Procedure: Plasmapheresis;Drug: Rabbit anti-thymocyte globulin;Drug: Methylprednisolone;Drug: Growth colony stimulating factor (G-CSF);Drug: Corticosteroids;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Intravenous immunoglobulin;Drug: Methotrexate;Drug: Rituximab;Drug: LeflunomideNational Institute of Allergy and Infectious Diseases (NIAID)NULLWithdrawn18 Years60 YearsBoth0Phase 2United States
3NCT00637819
(ClinicalTrials.gov)
January 200311/3/2008Leflunomide in Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)Systemic Lupus Eythematosus (SLE)Drug: LeflunomideSanofiNULLCompleted18 YearsN/ABoth27Phase 2Hong Kong

53. シェーグレン症候群


臨床試験数 : 283 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05113004
(ClinicalTrials.gov)
January 5, 20222/11/2021New Clinical End-points in Patients With Primary Sjögren's SyndromeNEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing PatientsPrimary Sjögren's Syndrome (pSS)Drug: Hydroxychloroquine 400mg/d;Drug: Leflunomide 20mg/d;Drug: Mycophenolate mofetil 2000mg/d;Drug: Placebo of Hydroxychloroquine 400mg/d;Drug: Placebo of Leflunomide 20mg/d;Drug: Placebo of Mycophenolate mofetil 2000mg/dAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting18 YearsN/AAll300Phase 2NULL
2EUCTR2019-002470-32-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
3EUCTR2020-001933-11-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
4EUCTR2014-003140-12-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

66. IgA腎症


臨床試験数 : 255 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04020328
(ClinicalTrials.gov)
September 12, 201910/7/2019Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal InsufficiencyA Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal InsufficiencyGlomerulonephritis, IGA;Renal Insufficiency, ChronicDrug: Leflunomide 20 mg+prednisone 0.5mg/kg/dShenzhen Second People's HospitalNULLRecruiting14 Years65 YearsAll70Phase 4China
2ChiCTR1800019606
2018-12-012018-11-19Effect of kunxian capsule and leflunomide on IgA nephropathyEffect of kunxian capsule and leflunomide on IgA nephropathy IgA nephropathy1:Kun-Xian Capsule;2:Leflunomide;The First Affiliated Hospital of Chengdu Medical CollegeNULLPending1575Both1:20;2:20;China
3ChiCTR-TRC-10000776
2010-02-272010-02-10A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathyA Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy lgA nephropathy;ICD:N03.81:Telmisartan+ Clopidogrelin placebo + Leflunomide placebo ;2:Telmisartan + Clopidogrelin+ Leflunomide placebo ;3:Telmisartan + Clopidogrelin placebo + Leflunomide;4:Telmisartan + Clopidogrelin + Leflunomide;Chinese General Hospital of PLANULLCompleted1855Both1:100;2:100;3:100;4:100;China

107. 若年性特発性関節炎


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02024334
(ClinicalTrials.gov)
June 201310/12/2013Efficacy Study of Leflunomide to Treat Juvenile Idiopathic ArthritisStudy of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: LeflunomideMashhad University of Medical SciencesNULLRecruiting2 Years19 YearsBoth30Phase 4Iran, Islamic Republic of

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 83 薬物数 : 128 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142
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
2NCT00802243
(ClinicalTrials.gov)
September 20073/12/2008Leflunomide Associated With Topical Corticosteroids for Bullous PemphigoidLeflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective StudyBullous PemphigoidDrug: leflunomideUniversity Hospital, LimogesNULLRecruiting65 YearsN/ABoth54Phase 2France

224. 紫斑病性腎炎


臨床試験数 : 13 薬物数 : 42 - (DrugBank : 20) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 57
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02532777
(ClinicalTrials.gov)
August 201520/8/2015The Research of Standard Diagnosis and Treatment for HSPN in ChildrenThe Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in ChildrenHenoch-Schoenlein Purpura NephritisDrug: Prednisone;Drug: Cyclophosphamide(CTX);Drug: Mycophenolate mofetil(MMF);Drug: Leflunomide(LEF);Drug: Angiotensin-converting enzyme inhibitor(ACEI);Drug: MethylprednisoloneNanjing Children's HospitalNULLRecruiting2 Years16 YearsAll100Phase 2China

270. 慢性再発性多発性骨髄炎


臨床試験数 : 1 薬物数 : 10 - (DrugBank : 9) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 73
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04725422
(ClinicalTrials.gov)
August 1, 201818/1/2021CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)Chronic Nonbacterial Osteomyelitis;Chronic Recurrent Multifocal OsteomyelitisDrug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Pamidronate;Drug: Zoledronic acid;Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab;Drug: GolimumabSeattle Children's HospitalBoston Children's Hospital, Boston, MA, USA;Hospital for Special Surgery, New York City, NY, USA;Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA;Riley Children's Hospital, Indianapolis, IN, USA;University of North Carolina, Chapel Hill, NC, USA;Royal Children's Hospital, Melbourne, Australia;Hacettepe University, Ankara, Turkey;Bambino Gesù Children's Hospital, Rome, Italy;University of British Columbia, Vancouver, BC, Canada;Meyer Children's Hospital, Florence, Italy;Mansoura university, faculty of medicine, EgyptRecruitingN/A21 YearsAll2000United States

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR-INR-17013574
2018-06-012017-11-28Clinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu DecoctionClinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu Decoction Ankylosing spondylitiscontrol group :Leflunomide;Intervention group :Chinese herbalshentongzhuyudecoction;The First Affiliated Hospital of Heilongjiang Chinese Medicine ColledgeNULLPending1625Malecontrol group :40;Intervention group :40;China

300. IgG4関連疾患


臨床試験数 : 36 薬物数 : 49 - (DrugBank : 22) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 98
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02703194
(ClinicalTrials.gov)
March 201627/2/2016Leflunomide for Maintenance of Remission in IgG4 Related DiseaseA Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related DiseaseImmunoglobulin G4 Related Sclerosing DiseaseDrug: Prednisone;Drug: LeflunomideChinese PLA General HospitalNULLCompleted18 Years80 YearsAll68Phase 4China