46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details


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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2010-020992-21-DE
(EUCTR)
25/03/201408/07/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 2Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina
2EUCTR2010-020992-21-GR
(EUCTR)
11/12/201206/12/2012Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4,5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. Rheumatoid Arthritis
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] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India
3EUCTR2010-020992-21-SK
(EUCTR)
26/10/201106/12/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. 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] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany
4EUCTR2010-020992-21-ES
(EUCTR)
17/10/201128/05/2012Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoideEstudio prospectivo, Fase IIb/III, multicéntrico, randomizado, doble ciego, controlado, de 3 grupos paralelos y 24 semanas de duración con posible extensión, para comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4,5 mg/kg/día, con metotrexato, con randomización 1:1:1, en el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos - AB1010 en tratamiento de pacientes con artritis reumatoide activa. Atritis Reumatoide
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] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: No aplica
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: no aplica
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: no aplica
INN or Proposed INN: METHOTREXATE
Other descriptive name: no aplica
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: No aplica
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: No aplica
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic
5EUCTR2010-020992-21-CZ
(EUCTR)
12/10/201118/07/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India
6NCT01410695
(ClinicalTrials.gov)
July 20114/8/2011Masitinib in Refractory Active Rheumatoid ArthritisA 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic DrugsRheumatoid Arthritis (RA)Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib)AB ScienceNULLTerminated18 YearsN/AAll324Phase 2/Phase 3Czechia;Czech Republic;France;United States
7NCT00913432
(ClinicalTrials.gov)
March 20073/6/2009Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid ArthritisA 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF AlphaRheumatoid ArthritisDrug: masitinibAB ScienceNULLCompleted18 YearsN/AAll20Phase 2NULL
8NCT00831922
(ClinicalTrials.gov)
September 200428/1/2009Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid ArthritisA Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)Rheumatoid ArthritisDrug: masitinib (AB1010)AB ScienceNULLCompleted18 YearsN/AAll43Phase 2NULL