Masitinib mesylate (DrugBank: Masitinib)
6 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 11 |
| 5 | 進行性核上性麻痺 | 0 |
| 6 | パーキンソン病 | 0 |
| 13 | 多発性硬化症／視神経脊髄炎 | 3 |
| 46 | 悪性関節リウマチ | 5 |
| 96 | クローン病 | 2 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-001862-13-SE (EUCTR) | 14/10/2020 | 23/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2019-001862-13-ES (EUCTR) | 15/09/2020 | 12/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2019-001862-13-SI (EUCTR) | 12/03/2020 | 19/02/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2010-024423-24-NL (EUCTR) | 21/09/2015 | 09/09/2015 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 5 | EUCTR2010-024423-24-IT (EUCTR) | 05/05/2015 | 04/02/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 2/3 sull'efficacia e la sicurezza di masitinib a confronto con placebo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) - AB10015 | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 18.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Other descriptive name: MASITINIB MESYLATE INN or Proposed INN: Masitinib Mesylate Other descriptive name: MASITINIB MESYLATE | AB SCIENCE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 381 | Portugal;Serbia;Slovakia;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Romania;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2010-024423-24-HU (EUCTR) | 21/04/2015 | 31/10/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Netherlands;Germany | ||
| 7 | EUCTR2010-024423-24-GR (EUCTR) | 06/03/2015 | 21/11/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany | ||
| 8 | EUCTR2010-024423-24-ES (EUCTR) | 29/01/2013 | 29/11/2012 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: MASITINIB | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy | ||
| 9 | EUCTR2010-024423-24-IE (EUCTR) | 06/11/2014 | A controlled clinical study to investigate the effectiveness and safety of the medicine called masitinib when used together with a currently available medicine Riluzole when treating the illness called Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 Study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS). - IRELAND Phase 2/3 study comparing Masitinib/Placebo in ALS | Amyotrophic lateral Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100 mg Tablets Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: SUB126308 Product Name: Masitinib 200 mg Tablets Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: SUB126308 | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Argentina;Belgium;Romania;Netherlands;Germany | |||
| 10 | EUCTR2019-001862-13-IE (EUCTR) | 04/08/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Product Name: Masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | NA | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2019-001862-13-GB (EUCTR) | 24/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Other descriptive name: na Product Name: Masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | NA | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-003735-32-GR (EUCTR) | 19/11/2015 | 06/08/2015 | Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Relapsing-remitting multiple sclerosis (RR MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 2 | EUCTR2010-021219-17-BG (EUCTR) | 27/10/2015 | 13/11/2013 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;South Africa;Tunisia;Germany;Bosnia and Herzegovina | ||
| 3 | EUCTR2010-021219-17-PL (EUCTR) | 07/11/2013 | 16/07/2013 | A 96 weeks study to compare efficacy and safety of masitinib to placebo in the treatment of patients with primary progressiveor relapse free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;Czech Republic;Slovakia;Greece;Spain;Poland;Romania;Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-020992-21-DE (EUCTR) | 25/03/2014 | 08/07/2011 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 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 Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2b;Phase 3 | Serbia;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 | ||
| 2 | EUCTR2010-020992-21-GR (EUCTR) | 11/12/2012 | 06/12/2012 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 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 Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India | ||
| 3 | EUCTR2010-020992-21-SK (EUCTR) | 26/10/2011 | 06/12/2011 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 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 Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany | ||
| 4 | EUCTR2010-020992-21-ES (EUCTR) | 17/10/2011 | 28/05/2012 | Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoide | Estudio 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 Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic | |||
| 5 | EUCTR2010-020992-21-CZ (EUCTR) | 12/10/2011 | 18/07/2011 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 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 Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2b;Phase 3 | United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-004222-25-GR (EUCTR) | 25/06/2015 | 26/06/2015 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Morocco;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Tunisia | ||
| 2 | EUCTR2012-004222-25-BE (EUCTR) | 26/11/2013 | 14/01/2013 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease | Crohn's disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | 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 | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Central African Republic;Slovakia;Greece;Spain;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Netherlands;Tunisia;Germany |