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"
22 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001064-11-GB
(EUCTR)
18/07/201731/03/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585Phase 3United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
2EUCTR2016-001064-11-CZ
(EUCTR)
20/04/201731/03/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585Phase 3United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
3EUCTR2016-001064-11-PL
(EUCTR)
13/04/201712/04/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585Phase 3United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom
4EUCTR2016-001064-11-ES
(EUCTR)
07/04/201707/04/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585Phase 3United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
5NCT02990806
(ClinicalTrials.gov)
December 201621/11/2016A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE)A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid ArthritisRheumatoid Arthritis (RA)Biological: NI-071;Biological: InfliximabNichi-Iko Pharmaceutical Co., Ltd.NULLCompleted18 Years75 YearsAll683Phase 3United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-002061-54-IT
(EUCTR)
13/10/201615/11/2018Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINULLNot RecruitingFemale: yes
Male: yes
250Phase 4Italy
7NCT02762838
(ClinicalTrials.gov)
January 20164/4/2016Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisInternational Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acidBiocadNULLCompleted18 Years75 YearsAll426Phase 3Belarus;India;Russian Federation
8NCT01962974
(ClinicalTrials.gov)
October 201311/10/2013A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)Arthritis, RheumatoidBiological: Golimumab 2 mg/kg IVJanssen Biotech, Inc.NULLTerminated18 Years76 YearsAll7Phase 3United States;Canada;Argentina;Brazil;Colombia;Mexico
9EUCTR2012-005733-37-GB
(EUCTR)
18/09/201323/07/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Rheumatoid Arthritis
MedDRA version: 16.0;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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
10EUCTR2012-005733-37-CZ
(EUCTR)
16/08/201315/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-005733-37-LV
(EUCTR)
02/08/201322/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Rheumatoid Arthritis
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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
12NCT01936181
(ClinicalTrials.gov)
August 20132/9/2013A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisDrug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab)Samsung Bioepis Co., Ltd.NULLCompleted18 Years75 YearsAll584Phase 3Bulgaria;Lithuania
13EUCTR2012-005733-37-LT
(EUCTR)
11/07/201320/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
14EUCTR2012-005733-37-BG
(EUCTR)
10/07/201321/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
15NCT01567358
(ClinicalTrials.gov)
February 201223/3/2012Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With MethotrexateRheumatoid ArthritisBiological: InfliximabNichi-Iko Pharmaceutical Co.,Ltd.NULLCompleted20 Years75 YearsBoth14Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2007-003288-36-ES
(EUCTR)
08/01/200909/03/2010Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTARTEnsayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
200Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
17NCT01245361
(ClinicalTrials.gov)
November 200719/11/2010A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial BenefitA Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001.Undifferentiated ArthritisDrug: Infliximab;Drug: sodium chloridePatrick DurezNULLCompletedN/AN/ABoth30N/ABelgium
18EUCTR2007-004694-26-BE
(EUCTR)
17/09/200710/09/2007A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UAA Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -
Saint-Luc Universitary HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Belgium
19EUCTR2007-002752-42-FR
(EUCTR)
13/09/200723/07/2007FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIRFAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR Polyarthrite rhumatoïde
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade®
INN or Proposed INN: INFLIXIMAB
CHRU de ToursNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
20EUCTR2006-004673-98-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00394589
(ClinicalTrials.gov)
March 200631/10/2006Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.Rheumatoid ArthritisDrug: Infliximab Control;Drug: Infliximab Increased Frequency;Drug: Infliximab Increased DoseMerck Sharp & Dohme Corp.Integrated Therapeutics GroupTerminated18 YearsN/AAll43Phase 3Austria;Belgium;Denmark;France;Germany;Netherlands;Sweden;Turkey
22NCT00099554
(ClinicalTrials.gov)
May 200416/12/2004Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)Rheumatoid ArthritisDrug: EtanerceptAmgenNULLCompleted18 YearsN/ABoth200Phase 4United States;Canada