46. 悪性関節リウマチ
[臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
50 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002810-37-PL
(EUCTR)
16/06/202011/03/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
2EUCTR2019-002810-37-BG
(EUCTR)
15/06/202028/04/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
3EUCTR2019-002810-37-LT
(EUCTR)
17/04/202003/03/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
4NCT04268771
(ClinicalTrials.gov)
April 8, 202031/1/2020A Phase III Transition Study of DRL Rituximab to Reference Medicinal ProductsA 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 ArthritisBiological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®Dr. Reddy's Laboratories LimitedPPDRecruiting18 YearsN/AAll140Phase 3United States
5EUCTR2019-002810-37-HU
(EUCTR)
09/03/202020/01/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2014-005368-13-IT
(EUCTR)
10/05/201716/02/2018A 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 LIMITEDNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
7NCT03161457
(ClinicalTrials.gov)
February 27, 201721/4/2017A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) TherapyRheumatoid Arthritis;Arthritis, RheumatoidBiological: JHL1101;Biological: MabTheraJHL Biotech, Inc.NULLTerminated18 Years80 YearsAll153Phase 1Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom
8EUCTR2014-005368-13-DE
(EUCTR)
22/11/201604/07/2016A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
9NCT03061838
(ClinicalTrials.gov)
October 27, 201620/2/2017Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera®Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: MabThera®;Drug: Ritumax®Biointegrator LLCNULLTerminated18 YearsN/AAll8Phase 1Russian Federation
10NCT02819726
(ClinicalTrials.gov)
October 11, 201620/6/2016PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid ArthritisA 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 ArthritisBiological: SAIT101;Biological: MabThera;Biological: RituxanArchigen Biotech LimitedNULLCompleted18 Years80 YearsAll294Phase 1United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2014-005368-13-ES
(EUCTR)
23/09/201615/07/2016A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
12EUCTR2014-005368-13-HU
(EUCTR)
19/09/201611/07/2016A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
13EUCTR2014-005368-13-CZ
(EUCTR)
13/09/201613/09/2016A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
14EUCTR2012-003876-38-PL
(EUCTR)
10/11/201516/11/2015Clinical 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 pastA 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)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
15EUCTR2012-003876-38-HU
(EUCTR)
28/07/201522/05/2015Clinical 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 pastA 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)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-003876-38-DE
(EUCTR)
21/07/201529/04/2015Clinical 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 pastA 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)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
17NCT02514772
(ClinicalTrials.gov)
July 201530/7/2015GP2013 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 ArthritisBiological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®SandozHexal AGCompleted18 YearsN/AAll107Phase 3United States;Germany;Hungary;Poland
18EUCTR2014-003255-54-CZ
(EUCTR)
21/01/201524/10/2014A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid ArthritisA Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients Rheumatoid arthritis
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] - Immune System Diseases [C20]
Product Name: RGB-03
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Gedeon Richter PlcNULLNot RecruitingFemale: yes
Male: yes
142Phase 1;Phase 3Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
19EUCTR2012-003194-25-HR
(EUCTR)
17/03/201403/09/2014Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisRandomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis Active Rheumatoid Arthritis
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]
Mabion S.A.NULLNot Recruiting Female: yes
Male: yes
863Phase 3Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia
20EUCTR2012-003223-38-DE
(EUCTR)
01/07/201308/04/2013Rheumatoid 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 10017NULLNot RecruitingFemale: yes
Male: yes
157Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02468791
(ClinicalTrials.gov)
May 20139/6/2015MabionCD20® Compared to MabThera® in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: RituximabMabion SANULLCompleted18 Years80 YearsAll709Phase 3Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine
22EUCTR2011-002896-40-PL
(EUCTR)
29/03/201311/02/2013A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
23EUCTR2012-003223-38-ES
(EUCTR)
27/02/201304/03/2013Rheumatoid 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 10017NULLNot RecruitingFemale: yes
Male: yes
157United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
24EUCTR2012-003194-25-LT
(EUCTR)
04/02/201324/09/2012Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisRandomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis Active Rheumatoid Arthritis
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: MabionCD20
INN or Proposed INN: Rituximab
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Mabion S.A.NULLNot RecruitingFemale: yes
Male: yes
863Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
25EUCTR2011-002896-40-DE
(EUCTR)
23/10/201202/07/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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 USNULLNot RecruitingFemale: yes
Male: yes
195United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01682512
(ClinicalTrials.gov)
September 5, 201210/8/2012Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid ArthritisEfficacy, 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, RheumatoidDrug: BI 695500;Drug: Rituxan®;Drug: MabThera®Boehringer IngelheimNULLTerminated18 Years80 YearsAll294Phase 3United 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
27EUCTR2011-005021-48-NL
(EUCTR)
07/06/201205/06/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
28EUCTR2011-005021-48-CZ
(EUCTR)
23/05/201215/02/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
29EUCTR2011-005021-48-ES
(EUCTR)
14/05/201221/02/2012A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
30EUCTR2011-005021-48-BG
(EUCTR)
09/05/201220/04/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-005021-48-HU
(EUCTR)
04/05/201215/02/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
32EUCTR2011-005021-48-PL
(EUCTR)
10/04/201214/03/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of
33EUCTR2011-004171-36-ES
(EUCTR)
30/03/201230/01/2012A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
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] - Musculoskeletal Diseases [C05]
Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLNot RecruitingFemale: yes
Male: yes
616Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of
34EUCTR2011-004171-36-PL
(EUCTR)
29/03/201222/02/2012A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
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] - Musculoskeletal Diseases [C05]
Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
35EUCTR2011-004171-36-GB
(EUCTR)
24/02/201215/12/2011A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
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] - Musculoskeletal Diseases [C05]
Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-004171-36-HU
(EUCTR)
23/02/201216/12/2011A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
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] - Musculoskeletal Diseases [C05]
Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
37EUCTR2011-004171-36-CZ
(EUCTR)
15/02/201230/11/2011A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
MedDRA version: 14.0;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: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLNot RecruitingFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
38NCT01613027
(ClinicalTrials.gov)
February 201225/5/2012An Observational Study of MabThera in Participants With Severe Active Rheumatoid ArthritisA Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)Rheumatoid ArthritisBiological: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll135N/AGreece
39NCT01390441
(ClinicalTrials.gov)
July 20117/7/2011A 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 ArthritisBiological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: LoratadineMerck Sharp & Dohme Corp.NULLTerminated18 Years65 YearsAll100Phase 1Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States
40EUCTR2009-015950-39-DE
(EUCTR)
12/05/201028/12/2009Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritisAddition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
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] - Musculoskeletal Diseases [C05]
Trade Name: MabThera®
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Johann Wolfgang Goethe-Universität Frankfurt/M.NULLNot RecruitingFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01071798
(ClinicalTrials.gov)
January 201018/2/2010An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid ArthritisA Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine CareRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll1653N/AGermany;United States
42NCT00845832
(ClinicalTrials.gov)
March 200917/2/2009A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to MethotrexateA Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLTerminated18 Years65 YearsAll24Phase 2France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden
43EUCTR2008-005525-11-FR
(EUCTR)
06/02/200913/03/2009A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera
Product Code: RO452294/V02
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533/F01
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81United Kingdom;Germany;Netherlands;France;Spain
44EUCTR2007-001585-33-LT
(EUCTR)
13/11/200705/07/2007A 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. SCOREA 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.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
45NCT00578305
(ClinicalTrials.gov)
November 200719/12/2007A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to MethotrexateA 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 MethotrexateRheumatoid ArthritisBiological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folateHoffmann-La RocheNULLCompleted18 Years80 YearsAll185Phase 3Argentina;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2007-001585-33-EE
(EUCTR)
10/10/200718/07/2007A 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. SCOREA 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.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
47EUCTR2006-004673-98-HU
(EUCTR)
16/10/200608/09/2006Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blockerEfficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.Trade Name: MabThera 500 mg concentrate for solution for infusionRoche (Hungary) Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Hungary
48NCT00074438
(ClinicalTrials.gov)
June 200312/12/2003Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid ArthritisRandomized, 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 ArthritisRheumatoid ArthritisDrug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted18 Years80 YearsBoth465Phase 2United States
49NCT02093026
(ClinicalTrials.gov)
August 200219/3/2014Extension 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 ArthritisRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic AcidHoffmann-La RocheGenentech, Inc.Completed21 YearsN/AAll465Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom
50EUCTR2011-002896-40-ES
(EUCTR)
26/06/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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 10017NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United 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