Namilumab (DrugBank: Namilumab)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 13 |
| 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 | EUCTR2014-002945-23-ES (EUCTR) | 30/04/2015 | 09/02/2015 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who?s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | 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] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Estonia;Czech Republic;Spain;Russian Federation;Latvia;United Kingdom | ||
| 2 | NCT02393378 (ClinicalTrials.gov) | April 8, 2015 | 15/3/2015 | Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate | Rheumatoid Arthritis | Drug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid | Takeda | NULL | Terminated | 18 Years | N/A | All | 7 | Phase 2 | Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic |
| 3 | EUCTR2013-002805-76-BG (EUCTR) | 20/02/2015 | 10/10/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose,efficacy and safety of 3 doses of namilumab combined with methotrexatein subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) 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: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom | ||
| 4 | EUCTR2014-002945-23-GB (EUCTR) | 18/02/2015 | 04/11/2014 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | 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] | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Estonia;Czech Republic;Spain;Russian Federation;United Kingdom | |||
| 5 | EUCTR2014-002945-23-CZ (EUCTR) | 18/02/2015 | 21/11/2014 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | 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] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Estonia;Czech Republic;Spain;Russian Federation;United Kingdom | ||
| 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 | JPRN-JapicCTI-152979 | 01/2/2015 | Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Intervention name : Namilumab Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study. Control intervention name : Placebo Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study. | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 20 | BOTH | 108 | Phase 2 | NULL | |||
| 7 | NCT02379091 (ClinicalTrials.gov) | December 17, 2014 | 28/11/2014 | Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Namilumab;Drug: Placebo;Drug: Methotrexate;Drug: Folic/folinic acid | Takeda | NULL | Completed | 18 Years | N/A | All | 108 | Phase 2 | Bulgaria;Czechia;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom;Argentina;Brazil;Colombia;Czech Republic;Germany;Mexico |
| 8 | EUCTR2014-002945-23-EE (EUCTR) | 16/12/2014 | 27/11/2014 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | Rheumatoid Arthritis (RA) MedDRA version: 18.1;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: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 9 | Phase 2 | Czech Republic;Estonia;Spain;Russian Federation;United Kingdom | ||
| 9 | EUCTR2013-002805-76-ES (EUCTR) | 06/11/2014 | 19/08/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study. | 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] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | United States;Spain;Russian Federation;Colombia;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Korea, Republic of | ||
| 10 | EUCTR2013-002805-76-GB (EUCTR) | 09/10/2014 | 30/12/2013 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Germany;Japan;United Kingdom | |||
| 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 | EUCTR2013-002805-76-DE (EUCTR) | 06/10/2014 | 27/01/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study. | 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] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | Czech Republic;Mexico;Argentina;Poland;Brazil;Spain;Russian Federation;Bulgaria;Colombia;Germany;United Kingdom;Korea, Republic of | ||
| 12 | EUCTR2013-002805-76-CZ (EUCTR) | 11/09/2014 | 17/07/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) 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: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom | ||
| 13 | NCT01317797 (ClinicalTrials.gov) | March 2011 | 18/2/2011 | A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis | A Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With Methotrexate | Rheumatoid Arthritis | Drug: namilumab (MT203);Drug: Placebo | Takeda | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | Bulgaria;Netherlands |