Rituxan® (DrugBank: -)
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 | 27 |
| 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 | EUCTR2019-002810-37-PL (EUCTR) | 16/06/2020 | 11/03/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | 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] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany | ||
| 2 | EUCTR2019-002810-37-BG (EUCTR) | 15/06/2020 | 28/04/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | 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] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany | ||
| 3 | EUCTR2019-002810-37-LT (EUCTR) | 17/04/2020 | 03/03/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | 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] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany | ||
| 4 | NCT04268771 (ClinicalTrials.gov) | April 8, 2020 | 31/1/2020 | A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products | A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | Rheumatoid Arthritis | Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera® | Dr. Reddy's Laboratories Limited | PPD | Recruiting | 18 Years | N/A | All | 140 | Phase 3 | United States |
| 5 | EUCTR2019-002810-37-HU (EUCTR) | 09/03/2020 | 20/01/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | 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] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary | ||
| 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 | EUCTR2014-005368-13-IT (EUCTR) | 10/05/2017 | 16/02/2018 | 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). - A Study Comparing SAIT101 to MabThera® or 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 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: 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 | ||
| 7 | 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 | ||
| 8 | NCT02819726 (ClinicalTrials.gov) | October 11, 2016 | 20/6/2016 | PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis | 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) | Rheumatoid Arthritis | Biological: SAIT101;Biological: MabThera;Biological: Rituxan | Archigen Biotech Limited | NULL | Completed | 18 Years | 80 Years | All | 294 | Phase 1 | United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain |
| 9 | EUCTR2014-005368-13-ES (EUCTR) | 23/09/2016 | 15/07/2016 | 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: 19.0;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 (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 | ||
| 10 | EUCTR2014-005368-13-HU (EUCTR) | 19/09/2016 | 11/07/2016 | 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: 19.0;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 (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 | India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy | ||
| 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 | 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 | ||
| 12 | EUCTR2012-003876-38-PL (EUCTR) | 10/11/2015 | 16/11/2015 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 19.1;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: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 13 | EUCTR2012-003876-38-HU (EUCTR) | 28/07/2015 | 22/05/2015 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 18.1;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: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 14 | EUCTR2012-003876-38-DE (EUCTR) | 21/07/2015 | 29/04/2015 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 19.0;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: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 15 | NCT02514772 (ClinicalTrials.gov) | July 2015 | 30/7/2015 | GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® | A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® | Rheumatoid Arthritis | Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ® | Sandoz | Hexal AG | Completed | 18 Years | N/A | All | 107 | Phase 3 | United States;Germany;Hungary;Poland |
| 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 |
| 16 | EUCTR2012-003223-38-DE (EUCTR) | 01/07/2013 | 08/04/2013 | Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials. | EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 | RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 157 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | ||
| 17 | EUCTR2011-002896-40-PL (EUCTR) | 29/03/2013 | 11/02/2013 | A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01 | RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | |||
| 18 | EUCTR2012-003223-38-ES (EUCTR) | 27/02/2013 | 04/03/2013 | Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials. | EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 | RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 157 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | |||
| 19 | EUCTR2011-002896-40-DE (EUCTR) | 23/10/2012 | 02/07/2012 | A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01 | RHEUMATOID ARTHRITIS MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US | NULL | Not Recruiting | Female: yes Male: yes | 195 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany | |||
| 20 | NCT01682512 (ClinicalTrials.gov) | September 5, 2012 | 10/8/2012 | Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis | Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial. | Arthritis, Rheumatoid | Drug: BI 695500;Drug: Rituxan®;Drug: MabThera® | Boehringer Ingelheim | NULL | Terminated | 18 Years | 80 Years | All | 294 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;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 |
| 21 | NCT01390441 (ClinicalTrials.gov) | July 2011 | 7/7/2011 | A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002) | A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 65 Years | All | 100 | Phase 1 | Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States |
| 22 | EUCTR2007-001585-33-LT (EUCTR) | 13/11/2007 | 05/07/2007 | A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE | A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE | Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | F. Hoffman-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia | |||
| 23 | NCT00578305 (ClinicalTrials.gov) | November 2007 | 19/12/2007 | A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 185 | Phase 3 | Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom |
| 24 | EUCTR2007-001585-33-EE (EUCTR) | 10/10/2007 | 18/07/2007 | A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE | A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE | Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | F. Hoffman-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia | |||
| 25 | NCT00074438 (ClinicalTrials.gov) | June 2003 | 12/12/2003 | Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis | Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Completed | 18 Years | 80 Years | Both | 465 | Phase 2 | United States |
| 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 |
| 26 | NCT02093026 (ClinicalTrials.gov) | August 2002 | 19/3/2014 | Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) | An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid | Hoffmann-La Roche | Genentech, Inc. | Completed | 21 Years | N/A | All | 465 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom |
| 27 | EUCTR2011-002896-40-ES (EUCTR) | 26/06/2012 | A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES | RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany |