Sait101 (proposed rituximab biosimilar) (DrugBank: Rituximab)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 46 | Malignant rheumatoid arthritis | 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 | EUCTR2014-005368-13-DE (EUCTR) | 22/11/2016 | 04/07/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
| 2 | EUCTR2014-005368-13-CZ (EUCTR) | 13/09/2016 | 13/09/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of |