Methotrexate Tablets ( DrugBank: Methotrexate )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
40高安動脈炎1
46悪性関節リウマチ26

40. 高安動脈炎


臨床試験数 : 24 薬物数 : 40 - (DrugBank : 18) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 110
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04299971
(ClinicalTrials.gov)
March 1, 20205/3/2020Efficiency of Methotrexate and Tofacitinib in Mild and Moderate PatientsRandomized Open-label Study in Mild and Moderate Patients With Takayasu Arteritis Between Methotrexate and Tofacitinib Based on the ECTA Cohort.Takayasu Arteritis;Methotrexate;Inhibition;TreatmentDrug: Methotrexate Tablets;Drug: Tofacitinib tabletShanghai Zhongshan HospitalNULLRecruiting14 Years100 YearsAll130Phase 4China

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
1ITMCTR2200006086
2022-07-012022-06-10Multicenter randomized double-blind clinical trial of Qufeng Zhitong Capsule combined with Methotrexate tablets in the treatment of rheumatoid arthritisMulticenter randomized double-blind clinical trial of Qufeng Zhitong Capsule combined with Methotrexate tablets in the treatment of rheumatoid arthritis rheumatoid arthritismatched group:Methotrexate tablet + qufeng analgesic capsule simulato;experimental group:Methotrexate tablet + qufeng analgesic capsule;Guang 'anmen Hospital, China Academy of Traditional Chinese MedicineNULLPending1875Bothmatched group:100;experimental group:100;Phase 4China
2NCT05380934
(ClinicalTrials.gov)
May 202216/5/2022A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy SubjectsA Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy SubjectsRheumatoid ArthritisDrug: TQH3821 tablets;Drug: TQH3821 tablets (Placebo);Drug: Methotrexate tabletsChia Tai Tianqing Pharmaceutical Group Co., Ltd.NULLRecruiting18 Years55 YearsAll62Phase 1China
3ChiCTR2100054305
2021-12-012021-12-13Observation on the clinical efficacy of Jiawei Qianyang Fengsui Dan in the treatment of RA with mixed syndrome of cold and heatObservation on the clinical efficacy of Jiawei Qianyang Fengsui Dan in the treatment of RA with mixed syndrome of cold and heat Rheumatoid ArthritisTreatment group:Modified Qianyang Fengsui Dan + Methotrexate Tablets + Folic Acid Tablets;Control group:Methotrexate + Folic Acid;Yunnan Provincial Hospital of Traditional Chinese MedicineNULLRecruiting1870BothTreatment group:36;Control group:36;China
4ChiCTR2100048769
2021-09-292021-07-16Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritisProspective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis rheumatoid arthritisTest group:Methotrexate tablets+Qufengzhitong capsule;control group:Methotrexate tablets+Qufeng Zhitong Capsule Placebo;Guang'anmen Hospital, China Academy of Chinese Medical SciencesNULLPending1875BothTest group:102;control group:102;Phase 4china
5ITMCTR2100005057
2021-09-292021-07-16Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritisProspective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis rheumatoid arthritiscontrol group:Methotrexate tablets+Qufeng Zhitong Capsule Placebo;Test group:Methotrexate tablets+Qufengzhitong capsule;Guang'anmen Hospital, China Academy of Chinese Medical SciencesNULLPending1875Bothcontrol group:102;Test group:102;Phase 4china
6ChiCTR2100042659
2021-01-252021-01-25Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulationObservation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation Rheumatoid Arthritisexperimental group:Fuzi Guizhi Decoction granules+Methotrexate tablets + Folic acid tablets;control group:Methotrexate tablets + Folic acid tablets;The Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1865Bothexperimental group:36;control group:36;China
7ITMCTR2100004321
2021-01-252021-01-25Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulationObservation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation Rheumatoid Arthritiscontrol group:Methotrexate tablets + Folic acid tablets;experimental group:Fuzi Guizhi Decoction granules+Methotrexate tablets + Folic acid tablets;The Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1865Bothcontrol group:36;experimental group:36;China
8ITMCTR2100004638
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 ArthritisControl group:Rebi cream simulant, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets;therapy group:Rebi ointment, 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 MedicineNULLRecruiting1870BothControl group:36;therapy group:36;China
9ChiCTR2100041821
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
10ChiCTR2100050865
2020-07-182021-09-05Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritisA multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis rheumatoid arthritisGroup 1:Tripterygium wilfordii polyglycoside tablets + Adamu monoclonal antibody;Group 2:Methotrexate tablets + Adamu monoclonal antibody;The Second Affiliated Hospital of Guizhou University of Traditional Chinese MedicineNULLRecruiting1880BothGroup 1:30;Group 2:30;Phase 4China
11ITMCTR2100005277
2020-07-182021-09-05Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritisA multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis rheumatoid arthritis1:Tripterygium wilfordii polyglycoside tablets + Adamu monoclonal antibody;2:Methotrexate tablets + Adamu monoclonal antibody ;The Second Affiliated Hospital of Guizhou University of Traditional Chinese MedicineNULLRecruiting1880Both1:30;2:30;Phase 4China
12ChiCTR1900026079
2018-10-252019-09-20Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical studyWangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study Rheumatoid ArthritisExperimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets;Longhua Hospital Shanghai University of Traditional Chinese MedicineNULLRecruiting1870BothExperimental group:60;Control group:60;Phase 4China
13EUCTR2016-000570-37-DE
(EUCTR)
19/04/201724/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
14EUCTR2016-000570-37-BG
(EUCTR)
21/03/201713/02/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
15EUCTR2016-000570-37-PL
(EUCTR)
15/02/201713/02/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Russian Federation;Hong Kong;United States;Malaysia;Thailand;Ireland;Poland;Brazil;Korea, Republic of;Slovakia;Chile;France;Serbia;Bulgaria;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Italy;Mexico;South Africa;Israel;Australia;Peru;Germany
16EUCTR2016-000570-37-BE
(EUCTR)
30/01/201717/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
17EUCTR2016-000570-37-ES
(EUCTR)
13/01/201713/01/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
18EUCTR2016-000570-37-CZ
(EUCTR)
05/01/201722/11/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
19EUCTR2016-000570-37-HU
(EUCTR)
02/12/201619/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
20EUCTR2016-000570-37-SK
(EUCTR)
29/11/201604/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
21EUCTR2016-000570-37-GB
(EUCTR)
14/11/201617/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
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: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
22NCT02940561
(ClinicalTrials.gov)
August 201615/9/2016BE Study in Patients - Methotrexate TabletsA Multicenter, Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single-dose, Two-way, Crossover, Bioequivalence Study of Methotrexate Tablets USP, 2.5 mg Manufactured by Amneal Pharmaceuticals, With Methotrexate Tablets USP 2.5 mg Manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in Patients With Mild to Severe Psoriasis or Rheumatoid Arthritis, Who Are Already on Established Regimens of 2.5 mg Every 12 Hours Under Fasting Condition.Psoriasis;Rheumatoid ArthritisDrug: Methotrexate - Amneal;Drug: Methotrexate - DAVAAmneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Recruiting18 Years65 YearsBoth48Phase 1India
23ChiCTR-TRC-10000989
2010-08-012010-08-05A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines –the Second TrialA 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines rheumatoid arthritis;M06.991observation group:Methotrexate Tablets, once per week, for first tim;observation group:Leigongtengduogan Pian, 10mg per time, 3 times per day, Yishen Juanbi Wan, 8g per time, 3 times per day, for oral administration, after meals ;Total:;The Ministry of Science and Technology of the People's Republic of ChinaNULLCompleted1870Maleobservation group:120;observation group:120;Total:240;China
24ChiCTR-IPR-14005684
2010-05-012014-11-14Compare with methotrexate tablets to evaluate the randomized double-blind, multicenter clinical trial to trial the efficacy and safety of the injection technetium 99Tc methylene diphosphonate treatment for active rheumatoid arthritis.Compare with methotrexate tablets to evaluate the randomized double-blind, multicenter clinical trial to trial the efficacy and safety of the injection technetium 99Tc methylene diphosphonate treatment for active rheumatoid arthritis. Rheumatoid arthritisYunke group:Yunke 16.5mg (5.5mg*3 sets) / time for each course of treatment, 100ml saline intravenous drip after dissolution and dilution, once a day for 7 successive days;MTX group :Four oral tablets each time, and gradually increase to 6 tablets each time in four weeks or to the maximum tolerated dose of the patients ;Combined treatment group :Yunke group+MTX group ;Shanghai Renji HospitalNULLCompleted1865BothYunke group:60;MTX group :60;Combined treatment group :60;China
25ChiCTR-TCC-12002824
2008-07-102012-12-08Traditional Chinese and anti-rheumatic drugs for the treatment of rheumatoid arthritisIntegration of Traditional Chinese and Western Medicine treat rheumatoid witharthritis: A prospective, randomized, controlled trial rheumatoid arthritis with peptic ulcerAcupuncture treatment:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint. ;ARD treatment:esomeprazole magnesium enteric-coated tablets ,celecoxib capsules and methotrexate tablets ;Combined therapy:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint + oral Shanhuang Wuji decoction ;Hospital of Chengdu Military Area Command PLANULLCompleted4565BothAcupuncture treatment:20;ARD treatment:20;Combined therapy:20;China
26ChiCTR-TRC-09000377
2007-07-012009-04-16Multicentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood FlowMulticentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood Flow rheumatoid arthritisGroup of MTX:Methotrexate Tablets: 10mg 1/w ;Group of Both MTX and Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid; Methotrexate Tablets: 10mg 1/w ;Group of Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid ;China Academy of Chinese Medical Science Guang'an Men HospitalNULLCompleted1865BothGroup of MTX:76;Group of Both MTX and Herbs:77;Group of Herbs:77;China