Msb11456 (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 46 | Malignant rheumatoid arthritis | 5 |
| 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 | EUCTR2019-004369-42-CZ (EUCTR) | 01/09/2020 | 05/08/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;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 Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of | ||
| 2 | NCT04512001 (ClinicalTrials.gov) | July 27, 2020 | 11/8/2020 | MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study) | Rheumatoid Arthritis | Drug: MSB11456;Drug: EU-approved RoActemra | Fresenius Kabi SwissBioSim GmbH | NULL | Recruiting | 18 Years | N/A | All | 542 | Phase 3 | Bulgaria;Czechia;Georgia;Hungary;Moldova, Republic of;Poland;Russian Federation;Serbia;Slovakia |
| 3 | EUCTR2019-004369-42-SK (EUCTR) | 12/05/2020 | 09/03/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;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 Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of | ||
| 4 | EUCTR2019-004369-42-PL (EUCTR) | 05/05/2020 | 23/03/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;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 Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Spain;Poland;Bulgaria;Russian Federation;Georgia;Moldova, Republic of | ||
| 5 | EUCTR2019-004369-42-HU (EUCTR) | 27/04/2020 | 03/03/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;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 Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of |