Dmard    (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464

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.
464 / 4,183 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04539964
(ClinicalTrials.gov)
January 202131/8/2020Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid ArthritisA Randomized, Sham-Controlled, Double-Blind Study of Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis: The RESET-RA StudyRheumatoid ArthritisProcedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Sham stimulationSetPoint Medical CorporationNULLNot yet recruiting22 Years75 YearsAll250Phase 3NULL
2NCT04286789
(ClinicalTrials.gov)
November 202025/2/2020Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDsA Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDsRheumatoid ArthritisDrug: Low dose ORTD-1;Drug: Low dose vehicle control;Drug: High dose ORTD-1;Drug: High dose vehicle controlOryn Therapeutics, LLCNULLRecruiting18 YearsN/AAll16Phase 1United States
3EUCTR2019-000867-26-DE
(EUCTR)
08/04/202004/07/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 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]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800Phase 3United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
4EUCTR2019-000868-18-DE
(EUCTR)
13/03/202008/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 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]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
5NCT04251741
(ClinicalTrials.gov)
March 1, 20208/1/2020Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab TreatmentUsing Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment: a Blinded Randomized Superiority TrialRheumatoid ArthritisDiagnostic Test: Adalimumab trough concentration;Other: Usual careReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and Development;Sint MaartenskliniekRecruiting18 YearsN/AAll84Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-000867-26-GB
(EUCTR)
10/12/201912/06/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Xeljanz
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800Phase 3United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
7EUCTR2019-000868-18-GB
(EUCTR)
02/12/201911/06/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Kevzara
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colo
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
8EUCTR2019-000867-26-PL
(EUCTR)
15/11/201915/07/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800Phase 3United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
9EUCTR2019-000868-18-PL
(EUCTR)
15/11/201911/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
10EUCTR2019-000868-18-ES
(EUCTR)
14/11/201926/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;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
11EUCTR2019-000867-26-ES
(EUCTR)
14/11/201909/07/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 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]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
12NCT04134728
(ClinicalTrials.gov)
October 31, 201918/10/2019Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) InhibitorsA 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase InhibitorsArthritis, RheumatoidBiological: GSK3196165;Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdRecruiting18 YearsN/AAll525Phase 3United States;Argentina;Belgium;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Lithuania;Poland;South Africa;Spain;United Kingdom
13EUCTR2019-000867-26-HU
(EUCTR)
24/10/201928/10/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Other descriptive name: TOFACITINIB CITRATE
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
14EUCTR2019-000868-18-HU
(EUCTR)
24/10/201928/10/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
15EUCTR2019-000867-26-BG
(EUCTR)
11/10/201930/07/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800Phase 3Germany;China;Japan;Korea, Republic of;United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-000867-26-EE
(EUCTR)
10/10/201901/08/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800Phase 3United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
17EUCTR2019-000868-18-CZ
(EUCTR)
20/09/201920/08/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of
18NCT04464642
(ClinicalTrials.gov)
July 10, 20196/7/2020Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid ArthritisTofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: TofacitinibDr. Mohammad Mamun KhanNULLActive, not recruiting18 YearsN/AAll110Phase 4Bangladesh
19NCT03970837
(ClinicalTrials.gov)
June 5, 201916/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDsArthritis, RheumatoidBiological: GSK3196165;Drug: Tofacitinib;Drug: Placebo to GSK3196165;Drug: Placebo to Tofacitinib;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdRecruiting18 YearsN/AAll1500Phase 3United States;Argentina;Australia;Bulgaria;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom
20NCT03813771
(ClinicalTrials.gov)
March 201912/9/2018Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell StratificationTargeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.Rheumatoid ArthritisDrug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: HydroxychloroquineUniversity of LeedsSamsung Bioepis Co., Ltd.Not yet recruiting18 YearsN/AAll106Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-000666-10-BE
(EUCTR)
19/02/201916/11/2018A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom
22EUCTR2018-000666-10-ES
(EUCTR)
23/01/201922/01/2019A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240Phase 2Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
23NCT03863405
(ClinicalTrials.gov)
January 9, 20194/3/2019Metformin Use in Rheumatoid ArthritisThe Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Metformin;Drug: Conventional DMARDs;Drug: Placebo Oral TabletAin Shams UniversityFuture University in EgyptRecruiting18 YearsN/AAll60Phase 2Egypt
24EUCTR2018-000666-10-HU
(EUCTR)
03/01/201929/10/2018A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom
25EUCTR2018-000666-10-GB
(EUCTR)
17/12/201824/10/2018A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03980639
(ClinicalTrials.gov)
November 20, 201818/1/2019Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBaseAbatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBaseRheumatoid ArthritisDrug: patient treated with DMARDUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll594226France
27NCT03682705
(ClinicalTrials.gov)
October 8, 201821/9/2018A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDsRheumatoid Arthritis (RA)Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placeboAbbVieNULLCompleted18 YearsN/AAll242Phase 2United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland
28NCT03660059
(ClinicalTrials.gov)
September 27, 201826/8/2018A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTXRheumatoid Arthritis (RA)Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)Astellas Pharma China, Inc.NULLActive, not recruiting18 YearsN/AAll385Phase 3China;Korea, Republic of;Taiwan
29EUCTR2015-004386-91-PL
(EUCTR)
26/08/201820/07/2016Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Poland;Germany
30EUCTR2017-004079-30-PT
(EUCTR)
09/08/201829/06/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Trade Name: RoActmera
Product Name: RoActmera
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Joint Research & Development Office (QMUL)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Belgium;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04066803
(ClinicalTrials.gov)
August 1, 201811/12/2018Optimal MTX Dose With Folic Acid Randomized Case-control TrialSafety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control StudyRheumatoid ArthritisDrug: MTX;Drug: Folic Acid;Drug: DMARDsSun Yat-sen UniversityShanghai Pharmaceuticals Holding Co., LtdRecruiting18 Years70 YearsAll160Phase 4China
32EUCTR2017-004079-30-ES
(EUCTR)
10/07/201821/03/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU Rhuematoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel
Joint Research & Development Office (QMUL)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Belgium;Spain;Italy
33EUCTR2016-002344-16-GB
(EUCTR)
28/06/201829/11/2017Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]University of LeedsNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
106Phase 4United Kingdom
34EUCTR2016-000933-37-BG
(EUCTR)
09/05/201812/01/2018Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Belarus;Portugal;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
35EUCTR2017-004054-41-BE
(EUCTR)
07/05/201815/03/2018COBRA-Slim with or without fast access to TNF blockade for remission induction in early RACareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020 early active Rheumatoid Arthritis, previously untreated with DMARDs
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]
University Hospitals LeuvenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
440Phase 4Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03449758
(ClinicalTrials.gov)
March 5, 20188/2/2018Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid ArthritisEffect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor InhibitorsRheumatoid ArthritisDrug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: SulfasalazineSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll84Phase 4France
37EUCTR2017-004079-30-BE
(EUCTR)
19/02/201819/02/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Joint Research & Development Office (QMUL)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
219Phase 3Portugal;Spain;Belgium;Italy
38EUCTR2016-004834-11-GB
(EUCTR)
23/10/201716/08/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02 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]
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR0686
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR6086
Trade Name: Methotrexate ® 2.5mg Tablets
Product Name: Methotrexate ® 2.5mg Tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
39NCT03163966
(ClinicalTrials.gov)
October 5, 20178/5/2017A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid ArthritisRheumatoid Arthritis, DMARD-naive and Early Disease PatientsDrug: CR6086;Drug: Methotrexate;Drug: PlaceboRottapharm BiotechNULLRecruiting18 YearsN/AAll240Phase 2Czechia
40NCT03254589
(ClinicalTrials.gov)
October 1, 201716/8/2017Methotrexate, Blood Pressure and Arterial Function in Rheumatoid ArthritisMethotrexate, Blood Pressure and Arterial Function in Rheumatoid ArthritisRheumatoid Arthritis;Stiffness, Aortic;Endothelial Dysfunction;Cardiovascular Risk FactorDrug: Methotrexate;Drug: Sulfasalazine;Drug: Other DMARDsFlinders UniversityUniversity of South Australia;medac GmbHRecruiting18 YearsN/AAll124Phase 4Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-004834-11-PL
(EUCTR)
05/09/201717/07/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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]
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
42EUCTR2016-004834-11-BG
(EUCTR)
04/09/201701/06/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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]
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
43EUCTR2016-004834-11-CZ
(EUCTR)
16/08/201702/08/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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]
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
44NCT03155347
(ClinicalTrials.gov)
August 2, 201715/5/2017An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) TherapyA Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD TherapyRheumatoid ArthritisDrug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to TocilizumabHoffmann-La RocheNULLRecruiting18 Years70 YearsAll340Phase 3China
45EUCTR2016-000569-21-NL
(EUCTR)
18/07/201729/06/2017Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;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
46EUCTR2016-004834-11-DK
(EUCTR)
06/07/201711/05/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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]
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
47ChiCTR-INR-17011772
2017-06-272017-06-28The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agentsThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents Rheumatoid Arthritistest group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group;Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated HospitalNULLRecruiting1865Bothtest group:80;Control group:40;China
48EUCTR2016-000933-37-NL
(EUCTR)
19/06/201718/04/2017Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
313Phase 3Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
49EUCTR2016-000933-37-SK
(EUCTR)
15/06/201724/04/2017Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
313Phase 3Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
50EUCTR2016-000569-21-FR
(EUCTR)
08/06/201704/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;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
51NCT03086343
(ClinicalTrials.gov)
May 9, 201720/3/2017A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDsA Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)Rheumatoid Arthritis (RA)Drug: Abatacept;Drug: Placebo for abatacept;Drug: Upadacitinib;Drug: Placebo for upadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll613Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Chile;Colombia
52EUCTR2016-000933-37-CZ
(EUCTR)
02/05/201722/11/2016Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
313Phase 3Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
53EUCTR2016-000569-21-DE
(EUCTR)
02/05/201704/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
54EUCTR2016-000933-37-DE
(EUCTR)
27/04/201717/10/2016Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
55EUCTR2016-000933-37-BE
(EUCTR)
14/03/201724/11/2016Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03082573
(ClinicalTrials.gov)
March 3, 201713/3/2017Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar GelOpen-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADsRheumatoid ArthritisDrug: H.P. Acthar gelIraj Sabahi Research Inc.MallinckrodtRecruiting21 YearsN/AAll30Phase 4United States
57EUCTR2016-000569-21-PL
(EUCTR)
15/02/201714/02/2017Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
58ChiCTR-IPR-17010325
2017-01-312017-01-04The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trialThe efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial rheumatic disease;M05.901Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityNULLPending1865BothMetformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100;China
59EUCTR2016-000933-37-PT
(EUCTR)
30/01/201709/11/2016Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Belarus;Portugal;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
60EUCTR2016-000569-21-BE
(EUCTR)
30/01/201728/10/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
423Phase 3Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of;United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2016-000569-21-ES
(EUCTR)
13/01/201713/01/2017Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Belgium;Australia;Germany;Japan;Korea, Republic of
62ChiCTR-IPR-17010307
2017-01-012017-01-01The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in ChinaThe efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China Rheumatoid Arthritis;M05.901Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityNULLRecruiting1865BothRapamycin group:200;Non-rapamycin group :100;China
63EUCTR2016-000933-37-ES
(EUCTR)
28/12/201617/11/2016Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Belarus;Spain;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Latvia;Norway;New Zealand
64EUCTR2016-000569-21-GB
(EUCTR)
23/12/201601/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
423Phase 3United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
65EUCTR2016-000569-21-HU
(EUCTR)
12/12/201607/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;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
66EUCTR2016-000933-37-LV
(EUCTR)
06/12/201631/10/2016Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Belarus;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Norway;Latvia;New Zealand
67EUCTR2016-000933-37-HU
(EUCTR)
24/11/201612/10/2016Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
313Phase 3Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
68EUCTR2015-005800-27-PL
(EUCTR)
08/11/201603/10/2016Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDsA randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: GSK3117391
Product Code: GSK3117391
INN or Proposed INN: Not applicable
Other descriptive name: GSK3117391
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Poland;Romania;Russian Federation
69NCT02919761
(ClinicalTrials.gov)
November 7, 201626/9/2016Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid ArthritisA Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD TreatmentArthritis, RheumatoidDrug: Acthar Gel;Drug: PlaceboMallinckrodtNULLCompleted18 YearsN/AAll259Phase 4United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
70ChiCTR-INR-16009546
2016-11-012016-10-21The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid ArthritisThe Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis rheumatoid arthritis;M05.901IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityNULLRecruiting1865BothIL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02037737
(ClinicalTrials.gov)
September 30, 201621/11/2013Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life SettingImpact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION StudyRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNULLCompleted18 YearsN/AAll153NULL
72EUCTR2015-003335-35-SI
(EUCTR)
12/09/201628/09/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
73NCT02930343
(ClinicalTrials.gov)
September 201613/9/2016Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate MonotherapyComparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control TrialRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: SulfasalazineJawaharlal Institute of Postgraduate Medical Education & ResearchNULLCompleted18 Years65 YearsAll136Phase 3India
74EUCTR2015-003335-35-BG
(EUCTR)
29/08/201601/08/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
75EUCTR2015-004386-91-DE
(EUCTR)
22/08/201618/05/2016Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
40Phase 2United States;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2015-003335-35-HU
(EUCTR)
18/08/201618/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden
77EUCTR2015-003335-35-FI
(EUCTR)
10/08/201622/04/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
78NCT02873936
(ClinicalTrials.gov)
July 27, 201617/8/2016Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) TreatmentA Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) TreatmentRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDsGilead SciencesGalapagos NVCompleted18 YearsN/AAll449Phase 3United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands
79EUCTR2015-003335-35-IT
(EUCTR)
18/07/201628/02/2018A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) - SELECT-BEYOND Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
80EUCTR2015-003335-35-GB
(EUCTR)
05/07/201617/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
499Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2015-003335-35-GR
(EUCTR)
05/07/201626/04/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
82NCT02799472
(ClinicalTrials.gov)
June 15, 201626/5/2016Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid ArthritisA Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDsArthritis, RheumatoidDrug: GSK3196165;Drug: Placebo;Drug: MTX;Drug: Folic (or folinic) acidGlaxoSmithKlineParexelCompleted18 YearsN/AAll39Phase 2United States;Germany;Poland
83EUCTR2015-003335-35-LV
(EUCTR)
03/06/201613/04/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden
84EUCTR2015-003335-35-PT
(EUCTR)
31/05/201630/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
85EUCTR2015-003335-35-FR
(EUCTR)
24/05/201617/06/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-003335-35-SK
(EUCTR)
19/05/201622/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
87EUCTR2015-003335-35-IE
(EUCTR)
13/05/201610/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
88EUCTR2015-003335-35-CZ
(EUCTR)
11/05/201615/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
89EUCTR2015-003335-35-SE
(EUCTR)
10/05/201616/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
90EUCTR2015-003335-35-AT
(EUCTR)
04/05/201614/04/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2015-003335-35-BE
(EUCTR)
04/05/201610/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
92EUCTR2015-003335-35-DK
(EUCTR)
03/05/201614/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
93EUCTR2015-003335-35-DE
(EUCTR)
03/05/201609/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
94EUCTR2015-003335-35-ES
(EUCTR)
29/04/201611/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Hong Kong;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Korea, Republic of;Turkey;Austria;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Norway;Germany;New Zealand;Sweden
95NCT02706847
(ClinicalTrials.gov)
March 15, 201618/2/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDsA Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)Rheumatoid ArthritisDrug: Upadacitinib;Drug: PlaceboAbbVieNULLActive, not recruiting18 Years99 YearsAll499Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Latvia;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Argentina;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Denmark;Hong Kong;Italy;Mexico;Norway;Slovenia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03355872
(ClinicalTrials.gov)
February 201622/11/2017A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDsA Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDsRheumatoid ArthritisDrug: HLX01Shanghai Henlius BiotechNULLCompleted18 Years65 YearsAll194Phase 1;Phase 2NULL
97NCT02643823
(ClinicalTrials.gov)
January 201623/12/2015Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid ArthritisSafety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid ArthritisRheumatoid ArthritisBiological: hUC-MSC + DMARDs;Drug: DMARDsShenzhen Hornetcorn Bio-technology Company, LTDFutian People's HospitalRecruiting18 Years80 YearsBoth40Phase 1China
98NCT02644499
(ClinicalTrials.gov)
December 31, 201530/12/2015Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid ArthritisComparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic AcidJawaharlal Institute of Postgraduate Medical Education & ResearchNULLCompleted18 YearsN/AAll186Phase 4India
99EUCTR2013-000337-13-PT
(EUCTR)
13/11/201511/11/2015 Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Universitätsklinikum ErlangenNULLNot Recruiting Female: yes
Male: yes
156Phase 3Serbia;United States;Portugal;Germany
100NCT02451748
(ClinicalTrials.gov)
August 20156/5/2015IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIAIL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIARheumatoid ArthritisOther: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humiraUniversity of Illinois at ChicagoUCB PharmaCompleted18 YearsN/AAll32Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2010-021184-32-BG
(EUCTR)
27/05/201514/04/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 18.0;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: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
102EUCTR2010-021184-32-PL
(EUCTR)
21/04/201506/02/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 18.0;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: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
103EUCTR2010-021184-32-GB
(EUCTR)
25/03/201512/06/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Hexal AGNULLNot Recruiting Female: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
104NCT02373202
(ClinicalTrials.gov)
February 201512/2/2015A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: MizoribineSanofiRegeneron PharmaceuticalsCompleted20 YearsN/AAll91Phase 3Japan
105EUCTR2010-021184-32-HU
(EUCTR)
09/01/201527/10/2014GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 17.1;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: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2014-003529-16-GB
(EUCTR)
16/12/201422/06/2015Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel
Joint Research & Development Office (QMUL)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
219Phase 3United Kingdom
107NCT02308163
(ClinicalTrials.gov)
August 8, 20142/12/2014A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDsPhase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDsRheumatoid ArthritisDrug: Peficitinib;Drug: Placebo;Biological: EtanerceptAstellas Pharma IncNULLCompleted20 YearsN/AAll509Phase 3Japan;Korea, Republic of;Taiwan
108NCT02219347
(ClinicalTrials.gov)
August 201415/8/2014Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)Rheumatoid ArthritisDrug: DMARD cessationNewcastle-upon-Tyne Hospitals NHS TrustNewcastle University;Wellcome TrustCompleted18 YearsN/AAll74N/AUnited Kingdom
109NCT02011334
(ClinicalTrials.gov)
July 20144/12/2013A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICARheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth285Phase 3Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
110NCT02046616
(ClinicalTrials.gov)
May 28, 201424/1/2014A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.Rheumatoid ArthritisDrug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll133Phase 3Denmark;Finland;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2010-020992-21-DE
(EUCTR)
25/03/201408/07/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. Rheumatoid Arthritis
MedDRA version: 17.1;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: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 2b;Phase 3Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina
112EUCTR2010-019262-86-NO
(EUCTR)
24/03/201408/10/2010Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND Rheumatoid Arthritis
MedDRA version: 16.1;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: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1940United States;Portugal;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Norway;Germany;New Zealand
113NCT02046603
(ClinicalTrials.gov)
March 4, 201424/1/2014A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic AgentOpen-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic AgentRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll162Phase 3United Kingdom
114EUCTR2013-002007-34-SE
(EUCTR)
20/02/201423/01/2014Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA Rheumatoid Arthritis
MedDRA version: 19.0;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: RoActemra
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
115EUCTR2013-002007-34-FI
(EUCTR)
10/02/201414/11/2013Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA Rheumatoid Arthritis
MedDRA version: 18.0;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]
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01987479
(ClinicalTrials.gov)
January 30, 20148/11/2013A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid ArthritisMulti-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCARRheumatoid ArthritisDrug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll150Phase 3Netherlands
117NCT02001987
(ClinicalTrials.gov)
January 201429/11/2013A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic TherapyA Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic TherapyRheumatoid ArthritisDrug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll139Phase 3France
118EUCTR2013-002007-34-DK
(EUCTR)
09/12/201309/12/2013Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA Rheumatoid Arthritis
MedDRA version: 19.0;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: RoActemra
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
119NCT01941095
(ClinicalTrials.gov)
November 20, 201330/8/2013A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid ArthritisMulticenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll100Phase 3Greece
120EUCTR2013-000342-19-NL
(EUCTR)
24/10/201308/10/2013A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug.MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Nederland B.V.NULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2013-002429-52-IE
(EUCTR)
23/10/201315/08/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab SC
Other descriptive name: TOCILIZUMAB SC
Roche Farma S.ANULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
122EUCTR2013-002429-52-PT
(EUCTR)
21/10/201308/08/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Farma S.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
123JPRN-JapicCTI-132277
01/10/2013AMG 162 Phase III study (DESIRABLE study)A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III) rheumatoid arthritisIntervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection
Control intervention name : Placebo
Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection
DAIICHISANKYO Co.,Ltd.NULL20BOTH642Phase 3NULL
124EUCTR2013-000054-22-GB
(EUCTR)
01/10/201307/08/2013OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENTOPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R
Roche Products LimitedNULLNot RecruitingFemale: yes
Male: yes
Phase 3United Kingdom
125NCT01973569
(ClinicalTrials.gov)
October 201325/10/2013AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) TreatmentA Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)Rheumatoid ArthritisDrug: denosumab;Drug: placeboDaiichi Sankyo, Inc.NULLCompleted20 YearsN/AAll679Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT01985464
(ClinicalTrials.gov)
October 201331/10/2013Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid ArthritisFeasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid ArthritisRheumatoid ArthritisBiological: Umbilical cord mesenchymal stem cellsTranslational BiosciencesNULLUnknown status18 YearsN/AAll20Phase 1;Phase 2Panama
127NCT01941940
(ClinicalTrials.gov)
September 5, 20132/9/2013A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) ParticipantsA National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) PatientsRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll227Phase 3Italy
128NCT01787149
(ClinicalTrials.gov)
September 20136/2/2013A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid ArthritisA Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid ArthritisCombination With DMARDsDrug: DMARDsMycenax Biotech Inc.NULLUnknown status20 YearsN/AAll98Phase 3Taiwan
129NCT01995201
(ClinicalTrials.gov)
September 20131/11/2013A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid ArthritisA Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLActive, not recruiting18 YearsN/ABoth401Phase 3Ireland;Portugal;Spain
130EUCTR2013-002429-52-ES
(EUCTR)
23/08/201312/07/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Farma S.ANULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2013-001569-17-IT
(EUCTR)
02/08/201304/06/2013A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients. 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] - Immune System Diseases [C20]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Roche S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3BItaly
132NCT01915537
(ClinicalTrials.gov)
August 201330/7/2013Infliximab and Classic DMARDs in the Rheumatoid Arthritis PatientsA Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor PrognosisRheumatoid Arthritis(RA)Drug: Infliximab group;Drug: Classic DMARDs treatment groupZhang, Xiao, M.D.Central South University;Tianjin Medical University General Hospital;Xijing HospitalNot yet recruiting18 Years70 YearsBoth170N/AChina
133NCT01932372
(ClinicalTrials.gov)
July 26, 201330/7/2013Tofacitinib (Xeljanz) Special Investigation for Rheumatoid ArthritisXELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)Rheumatoid ArthritisDrug: Tofacitinib (Xeljanz);Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etcPfizerNULLActive, not recruitingN/AN/AAll9968Japan
134NCT01881308
(ClinicalTrials.gov)
June 17, 201317/6/2013Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid ArthritisREmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority DesignRheumatoid ArthritisDrug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDsDiakonhjemmet HospitalThe Research Council of Norway;South-Eastern Norway Regional Health AuthorityActive, not recruiting18 Years80 YearsAll360Phase 4Norway
135NCT01878318
(ClinicalTrials.gov)
June 20136/6/2013A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDsOpen Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDsRheumatoid ArthritisDrug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLWithdrawn18 YearsN/ABoth0Phase 4Venezuela
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT01885819
(ClinicalTrials.gov)
June 201318/6/2013Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid ArthritisFeasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid ArthritisRheumatoid ArthritisBiological: Autologous stromal vascular fraction cellsTranslational BiosciencesNULLWithdrawn18 YearsN/AAll0Phase 1;Phase 2Panama
137EUCTR2013-000337-13-DE
(EUCTR)
13/05/201312/02/2013Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
156Phase 3Serbia;Portugal;Germany
138EUCTR2010-019262-86-SK
(EUCTR)
02/05/201304/03/2013Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND Rheumatoid Arthritis
MedDRA version: 15.1;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: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2100Phase 3Portugal;United States;Belarus;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;New Zealand;Sweden
139EUCTR2011-003538-16-PL
(EUCTR)
23/04/201308/03/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET Rheumatoid Arthritis
MedDRA version: 18.0;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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
140EUCTR2011-002894-48-NO
(EUCTR)
11/04/201306/09/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT01547091
(ClinicalTrials.gov)
April 201322/2/2012Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid ArthritisClinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/IIRheumatoid ArthritisBiological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDSAlliancells Bioscience Corporation LimitedNULLRecruiting18 Years70 YearsBoth200Phase 1;Phase 2China
142EUCTR2011-003538-16-CZ
(EUCTR)
29/03/201308/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET Rheumatoid Arthritis
MedDRA version: 17.1;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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
143EUCTR2011-003538-16-DE
(EUCTR)
26/03/201310/12/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
144EUCTR2011-003538-16-PT
(EUCTR)
14/03/201313/12/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
145EUCTR2011-003538-16-IT
(EUCTR)
08/03/201314/01/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET Rheumatoid Arthritis
MedDRA version: 15.1;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: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab
Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab
SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2011-003538-16-AT
(EUCTR)
19/02/201314/01/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
147EUCTR2011-003538-16-GR
(EUCTR)
18/02/201314/01/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand
148EUCTR2011-003538-16-HU
(EUCTR)
14/02/201314/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET Rheumatoid Arthritis
MedDRA version: 17.1;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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
149EUCTR2010-022242-24-BG
(EUCTR)
07/02/201311/12/2012A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;Bulgaria;South Africa;Japan;Korea, Republic of
150EUCTR2011-002894-48-BG
(EUCTR)
06/02/201320/11/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2011-003538-16-LT
(EUCTR)
04/02/201305/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET Rheumatoid Arthritis
MedDRA version: 16.1;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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
152EUCTR2011-003538-16-SK
(EUCTR)
29/01/201308/03/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET Rheumatoid Arthritis
MedDRA version: 15.1;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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
153EUCTR2011-002894-48-DE
(EUCTR)
25/01/201324/07/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
154EUCTR2011-002894-48-ES
(EUCTR)
18/01/201329/10/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
INN or Proposed INN: Not applicable
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
155EUCTR2011-003538-16-ES
(EUCTR)
16/01/201329/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-? Antagonists - SARIL-RA-TARGET 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: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT01715831
(ClinicalTrials.gov)
January 15, 201325/10/2012A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab TreatmentArthritis, RheumatoidDrug: DMARDs;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll26Phase 4Brazil
157NCT01965132
(ClinicalTrials.gov)
January 1, 201311/10/2013Korean College of Rheumatology Biologics RegistryKorean College of Rheumatology Biologics RegistryRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Biologic DMARDSeoul National University HospitalNULLRecruiting18 YearsN/AAll7000Korea, Republic of
158NCT01491815
(ClinicalTrials.gov)
December 14, 20128/12/2011Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose ReductionA Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to TreatmentRheumatoid ArthritisDrug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemraKarolinska InstitutetNULLActive, not recruiting18 YearsN/AAll812Phase 4Denmark;Finland;Iceland;Netherlands;Norway;Sweden
159EUCTR2010-020992-21-GR
(EUCTR)
11/12/201206/12/2012Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4,5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. Rheumatoid Arthritis
MedDRA version: 15.1;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: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India
160JPRN-UMIN000009425
2012/12/0601/12/2012A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient Rheumatoid ArthritisThe dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.
Osaka City University Medical SchoolNULLRecruiting20years-oldNot applicableMale and Female150Phase 4Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT01717846
(ClinicalTrials.gov)
December 201224/10/2012Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid ArthritisIn Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid ArthritisApoptotic DNA Damage;Rheumatoid Arthritis;T-cell LymphocytosisDrug: Group 1 or Orencia treated group;Other: Group 2 (DMARDS treated group)University of California, Los AngelesBristol-Myers SquibbWithdrawn18 Years85 YearsBoth0Phase 4United States
162NCT01759030
(ClinicalTrials.gov)
December 201220/12/2012Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid ArthritisDouble Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor TherapiesRheumatoid ArthritisDrug: RituximabBiocadNULLCompleted18 Years80 YearsAll181Phase 3Belarus;India;Russian Federation;Ukraine;Colombia
163EUCTR2011-002894-48-GR
(EUCTR)
16/11/201219/10/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
164EUCTR2011-002894-48-PT
(EUCTR)
09/11/201209/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 15.1;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 Code: BI 695500
INN or Proposed INN: No Active Name Specified
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
165EUCTR2012-001760-30-IT
(EUCTR)
05/11/201225/07/2012Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent. 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] - Immune System Diseases [C20]
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
OSSERVATORIO EPIDEMIOLOGICO GISEANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2011-002894-48-HU
(EUCTR)
16/10/201216/08/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
167EUCTR2011-002894-48-EE
(EUCTR)
08/10/201208/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
168NCT01709578
(ClinicalTrials.gov)
October 201215/10/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a AntagonistsRheumatoid ArthritisDrug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomideSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll546Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong
169EUCTR2011-002894-48-GB
(EUCTR)
14/09/201206/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
300Phase 1;Phase 3Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
170EUCTR2011-002894-48-NL
(EUCTR)
10/09/201214/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT01661140
(ClinicalTrials.gov)
September 20127/8/2012A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate DosageRandomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTXRheumatoid ArthritisDrug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose)Hoffmann-La RocheNULLTerminated18 YearsN/AAll427Phase 4United Kingdom
172EUCTR2011-002894-48-BE
(EUCTR)
02/08/201218/07/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Phase 1;Phase 3Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
173NCT01604343
(ClinicalTrials.gov)
August 201221/5/2012A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite DMARD TherapyArthritis, RheumatoidDrug: Placebo;Drug: SirukumabJanssen Research & Development, LLCGlaxoSmithKlineCompleted18 YearsN/ABoth1670Phase 3United States;Bulgaria;Canada;Chile;Colombia;Croatia;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa;Taiwan;Ukraine;Argentina;Brazil;India;Peru
174EUCTR2010-022242-24-LT
(EUCTR)
11/07/201229/05/2012A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;South Africa;Bulgaria;Japan;Korea, Republic of
175NCT01578850
(ClinicalTrials.gov)
July 201212/4/2012Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to ScreeningA Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)Rheumatoid ArthritisDrug: Etanercept;Drug: placeboPfizerNULLCompleted18 Years70 YearsAll491Phase 4Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2011-005260-20-GB
(EUCTR)
28/06/201210/05/2012RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER Adult Rheumatoid Arthritis (RA)
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]
Roche Products LimitedNULLNot Recruiting Female: yes
Male: yes
618Phase 4United Kingdom
177EUCTR2011-005204-15-AT
(EUCTR)
20/06/201215/05/2012Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und ImmunologieNULLNot RecruitingFemale: yes
Male: yes
110Phase 4Austria
178EUCTR2011-001729-25-NL
(EUCTR)
11/06/201205/03/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 15.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
179EUCTR2011-005448-87-CZ
(EUCTR)
11/06/201212/04/2012A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S) 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] - Immune System Diseases [C20]
Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe
INN or Proposed INN: ETANERCEPT
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
320United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
180EUCTR2011-001729-25-GB
(EUCTR)
01/06/201219/04/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active 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]
UCB Pharma SANULLNot Recruiting Female: yes
Male: yes
800Phase 3United States;Spain;Ireland;Austria;Colombia;Italy;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT01602302
(ClinicalTrials.gov)
June 201216/5/2012Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid ArthritisUltrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid ArthritisRheumatoid ArthritisDrug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)Medical University of GrazNULLTerminated18 Years90 YearsAll40Phase 4Austria
182EUCTR2011-001729-25-IT
(EUCTR)
23/05/201219/03/2012Study designed to demonstrate the efficacy and safety of certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritisA multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. Early active 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]
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
INN or Proposed INN: METHOTREXATE
UCB PHARMA SA/NV.NULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
183EUCTR2011-001729-25-SE
(EUCTR)
22/05/201222/02/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active 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]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
184EUCTR2011-005448-87-HU
(EUCTR)
14/05/201221/03/2012A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S) 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] - Immune System Diseases [C20]
Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe
INN or Proposed INN: ETANERCEPT
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
320United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
185NCT01617005
(ClinicalTrials.gov)
May 20128/6/2012A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll50N/AMontenegro
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2011-001729-25-DE
(EUCTR)
11/04/201210/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
187EUCTR2011-001729-25-CZ
(EUCTR)
03/04/201203/02/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active 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]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
188EUCTR2010-021184-32-EE
(EUCTR)
23/03/201208/03/2012GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 18.0;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: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Germany
189EUCTR2011-001729-25-HU
(EUCTR)
22/03/201226/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active 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]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
190EUCTR2011-001729-25-ES
(EUCTR)
16/03/201227/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active 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]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2011-001729-25-IE
(EUCTR)
09/03/201212/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active 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]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
192EUCTR2011-001729-25-AT
(EUCTR)
08/03/201208/02/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
193NCT01519791
(ClinicalTrials.gov)
January 201219/1/2012A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Certolizumab Pegol;Other: Placebo;Biological: MethotrexateUCB Pharma SANULLCompleted18 YearsN/AAll880Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic
194NCT01521923
(ClinicalTrials.gov)
January 201219/1/2012A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX)UCB PharmaNULLCompleted18 YearsN/AAll359Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic
195NCT01511003
(ClinicalTrials.gov)
December 5, 20114/1/2012A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDsRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Completed20 Years75 YearsAll128Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT01326962
(ClinicalTrials.gov)
November 30, 20117/3/2011A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNFTocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNFRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll28Phase 3Saudi Arabia
197NCT01251120
(ClinicalTrials.gov)
November 201130/11/2010A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid ArthritisA Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: DMARDHoffmann-La RocheNULLTerminated18 YearsN/AAll2Phase 4Finland
198EUCTR2010-020992-21-SK
(EUCTR)
26/10/201106/12/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide 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] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany
199EUCTR2010-020992-21-CZ
(EUCTR)
12/10/201118/07/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. Rheumatoid Arthritis
MedDRA version: 16.1;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: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 2b;Phase 3United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India
200NCT01548768
(ClinicalTrials.gov)
October 10, 20116/3/2012RHYTHM (Formerly Escape II Myocardium)RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.Rheumatoid ArthritisDrug: TNF inhibitors;Drug: DMARDsColumbia UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 YearsN/AAll149Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2010-019912-18-BG
(EUCTR)
03/10/201125/08/2011A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa Adult 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: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody
Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
600United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
202NCT01292616
(ClinicalTrials.gov)
October 20118/2/2011Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine InvolvementRheumatoid ArthritisDrug: therapy with disease-modifying anti rheumatic drugs (DMARD)University of ZurichNULLRecruiting18 YearsN/ABoth15N/ASwitzerland
203NCT01245439
(ClinicalTrials.gov)
September 201117/11/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisLocal Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll65Phase 3Turkey
204EUCTR2010-019912-18-HU
(EUCTR)
31/08/201108/06/2011A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa Adult Rheumatoid Arthritis (RA)
MedDRA version: 13.1;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: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody
Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
600United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
205EUCTR2010-021184-32-IT
(EUCTR)
03/08/201102/02/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 16.1;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: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2010-022206-40-PL
(EUCTR)
26/07/201111/04/2011A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
207NCT01410695
(ClinicalTrials.gov)
July 20114/8/2011Masitinib in Refractory Active Rheumatoid ArthritisA 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic DrugsRheumatoid Arthritis (RA)Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib)AB ScienceNULLTerminated18 YearsN/AAll324Phase 2;Phase 3Czechia;Czech Republic;France;United States
208EUCTR2010-019262-86-ES
(EUCTR)
22/06/201121/04/2010Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) Artritis Reumatoide_______________________Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: SAR153191sanofi-aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania
209EUCTR2010-021184-32-BE
(EUCTR)
08/06/201114/04/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti- TNF therapies Refractory rheumatoid arthritis
MedDRA version: 16.1;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: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the US
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
210EUCTR2011-003016-23-IT
(EUCTR)
11/05/201107/03/2012Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapyControlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDY Rheumatoid Arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Guna-Anti Interleukin 1
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Antiinterleukin 1 alfa
INN or Proposed INN: NA
Other descriptive name: Guna-Antiinterleukin 1 beta
Product Name: Interleukin 10
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Interleukin 10
Product Name: Interleukin 4
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Interleukin 4
GUNA SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2010-019912-18-GR
(EUCTR)
18/04/201101/04/2011A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritisA randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis Rheumatoid arthritis (RA)
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: tocilizumab 162mg/0.9ml SC PFS SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Greece;Spain;Bulgaria
212EUCTR2010-022206-40-LT
(EUCTR)
01/04/201128/12/2010A Rheumatoid Arthritis Study in Patients(FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) Rheumatoid Arthritis
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: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Australia;Peru;South Africa;Bulgaria;Japan;New Zealand
213EUCTR2010-022206-40-BG
(EUCTR)
30/03/201124/02/2011A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) Rheumatoid Arthritis
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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
214EUCTR2010-021577-37-BG
(EUCTR)
24/03/201104/02/2011A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS 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: Anti Lymphotoxin Alpha
Product Code: MLTA3698A
Other descriptive name: Anti lymphotoxin alpha
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Mexico;Spain;Peru;Chile;Bulgaria;Germany
215EUCTR2010-021577-37-DE
(EUCTR)
17/03/201129/10/2010A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Spain;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT01232569
(ClinicalTrials.gov)
March 20111/11/2010A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Tocilizumab 162 mg;Drug: PlaceboHoffmann-La RocheNULLCompleted18 YearsN/AAll656Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru
217NCT01313208
(ClinicalTrials.gov)
March 201110/3/2011Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD TherapyRheumatoid ArthritisDrug: etanercept;Drug: Placebo;Drug: DMARD TherapyAmgenNULLCompleted18 Years80 YearsAll210Phase 4United States;Canada
218NCT01353859
(ClinicalTrials.gov)
March 201113/5/2011A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDsAn Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll39Phase 3Indonesia;Greece
219NCT01332994
(ClinicalTrials.gov)
March 201118/3/2011A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid ArthritisEfficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll519Phase 3Germany
220EUCTR2010-022206-40-HU
(EUCTR)
23/02/201126/11/2010A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) TherapyA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3Hungary;Poland;Lithuania;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2010-020744-35-IT
(EUCTR)
18/02/201122/12/2010A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2 Patients with active Rheumatoid Arthritis despite current treatment with a DMARD.
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;United Kingdom;Italy
222EUCTR2010-020744-35-DE
(EUCTR)
17/02/201121/07/2010Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (OSKIRA - 2)A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
223NCT01235507
(ClinicalTrials.gov)
February 201115/10/2010A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDsRheumatoid ArthritisDrug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll71Phase 3Bosnia and Herzegovina
224NCT01254331
(ClinicalTrials.gov)
February 20113/12/2010An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local EnvironmentOpen Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll51Phase 3Tunisia
225EUCTR2010-021577-37-ES
(EUCTR)
27/01/201123/11/2010ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Artritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Germany;Bulgaria;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2010-019912-18-ES
(EUCTR)
17/01/201119/01/2011A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. Rheumatoid arthritis (RA)Artritis Reumatoide (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tocilizumab 162mg/0.9ml SC PFS SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Hungary;Spain;Greece
227EUCTR2010-022049-88-DE
(EUCTR)
05/01/201111/11/2010Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAIEfficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI 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: RoActemra 20 mg/ml Concentrate for solution for infusion
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Trade Name: Mabthera 500 mg Concentrate for solution for infusion
Product Name: Rituximab
Product Code: RO045-2294
INN or Proposed INN: RITUXIMAB
Roche Pharma AGNULLNot RecruitingFemale: yes
Male: yes
Germany
228NCT01202760
(ClinicalTrials.gov)
January 201114/9/2010A Rheumatoid Arthritis Study in ParticipantsA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)Rheumatoid ArthritisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll1004Phase 3United States;Argentina;Australia;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru
229NCT01274182
(ClinicalTrials.gov)
January 201110/1/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.Rheumatoid ArthritisBiological: GP2013;Biological: MabThera;Biological: RituxanSandozNovartis PharmaceuticalsCompleted18 YearsN/AAll312Phase 1;Phase 2United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey
230EUCTR2010-020744-35-PT
(EUCTR)
17/12/201016/09/2010A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2010-021577-37-HU
(EUCTR)
16/12/201027/10/2010A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Spain;Bulgaria;Germany
232EUCTR2010-022206-40-SK
(EUCTR)
13/12/201027/04/2016A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) Rheumatoid Arthritis
MedDRA version: 19.0;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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
233EUCTR2010-020744-35-ES
(EUCTR)
13/12/201023/09/2010A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2 Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
234EUCTR2010-021184-32-DE
(EUCTR)
30/11/201030/08/2010GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory rheumatoid arthritis
MedDRA version: 19.0;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: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
235EUCTR2010-018375-22-BG
(EUCTR)
25/11/201023/09/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2010-021184-32-AT
(EUCTR)
11/11/201019/10/2010GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory 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: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
288Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
237NCT01225393
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placeboGenentech, Inc.NULLCompleted18 Years75 YearsBoth211Phase 2Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
238EUCTR2008-006924-68-AT
(EUCTR)
28/10/201012/01/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy
239EUCTR2010-021184-32-FR
(EUCTR)
28/10/201013/09/2010A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapiesA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapies Refractory rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy
240NCT01362062
(ClinicalTrials.gov)
October 26, 201026/5/2011Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) TherapyA Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll110N/AIndia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2010-020744-35-GB
(EUCTR)
26/10/201005/07/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 Rheumatoid Arthritis
MedDRA version: 13.1;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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
242EUCTR2010-020744-35-LV
(EUCTR)
22/10/201013/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
243EUCTR2010-020744-35-CZ
(EUCTR)
11/10/201030/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 Rheumatoid Arthritis
MedDRA version: 13.1;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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
244EUCTR2010-018375-22-LT
(EUCTR)
11/10/201016/08/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
245EUCTR2010-020744-35-LT
(EUCTR)
11/10/201018/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2010-018375-22-DE
(EUCTR)
05/10/201014/07/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA Rheumatoid arthritis
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: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1200United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
247NCT01149057
(ClinicalTrials.gov)
October 201022/6/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDSAn Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheClalit Health ServicesCompleted18 YearsN/AAll145Phase 4Israel
248NCT01214733
(ClinicalTrials.gov)
October 20104/10/2010A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid ArthritisAn Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth30Phase 3South Africa
249EUCTR2010-019262-86-GR
(EUCTR)
28/09/201023/09/2010A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: SAR153191
sanofi-aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania
250EUCTR2010-019935-37-FI
(EUCTR)
15/09/201002/07/2010A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid ArthritisA pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term:
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Other descriptive name: TOCILIZUMAB
Roche OyNULLNot RecruitingFemale: yes
Male: yes
160Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2010-018375-22-GB
(EUCTR)
14/09/201029/06/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
1200Phase 3United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
252NCT01194414
(ClinicalTrials.gov)
September 20101/9/2010A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid ArthritisA Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab SC;Drug: tocilizumab IV;Drug: placebo to tocilizumab SC;Drug: placebo to tocilizumab IV;Drug: Disease-modifying antirheumatic drugs (DMARDs)Hoffmann-La RocheNULLCompleted18 YearsN/AAll1262Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Guatemala;Hong Kong;Italy;Lithuania;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Singapore;South Africa;Spain;Thailand;United Kingdom
253NCT01197534
(ClinicalTrials.gov)
September 20108/9/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDsRheumatoid ArthritisDrug: fostamatinib;Drug: placebo, fostamatinibAstraZenecaNULLCompleted18 YearsN/AAll913Phase 3United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom
254EUCTR2010-018375-22-ES
(EUCTR)
03/08/201004/06/2010A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. Rheumatoid arthritisArtritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tocilizumab 162mg/0.9ml jeringa SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Germany;United Kingdom;Bulgaria;Spain;Italy;Lithuania
255NCT01195272
(ClinicalTrials.gov)
August 20102/9/2010A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll21Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2010-018375-22-IT
(EUCTR)
29/07/201005/07/2010A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - NDA randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1200Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
257JPRN-UMIN000003880
2010/07/0107/07/2010Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area Rheumatoid arthritisDAS28>3.2 at 24 weeks
Switching to another biologics
DAS28>3.2 at 24 weeks
Dose up of MTX or addition of other DMARDs
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every two week
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every four week
Osaka City University Medical SchoolHigashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu HospitalRecruiting20years-oldNot applicableMale and Female100Not applicableJapan
258JPRN-UMIN000003807
2010/07/0101/07/2010A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis Rheumatoid ArthritisCombination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate
Japan Association of Rheumatologists in Private PracticeNULLComplete: follow-up completeNot applicableNot applicableMale and Female160Not applicableJapan
259NCT01593332
(ClinicalTrials.gov)
July 20107/1/2012Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid ArthritisDMARD Resistant Rheumatoid ArthritisDrug: RituximabMashhad University of Medical SciencesRoche Pharma AGCompleted19 Years75 YearsBoth44Phase 4Iran, Islamic Republic of
260EUCTR2010-018331-18-GB
(EUCTR)
12/05/201018/03/2010A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyA 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2009-015950-39-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
262JPRN-UMIN000003615
2010/05/0114/05/2010Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA RA(Rheumatoid Arthritis)Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 monthsSt Luke's International HospitalNULLRecruiting20years-old80years-oldMale and Female20Not selectedJapan
263EUCTR2009-011137-26-PL
(EUCTR)
01/04/201025/01/2010An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland
264EUCTR2009-011137-26-GR
(EUCTR)
22/03/201020/10/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
265EUCTR2009-011137-26-PT
(EUCTR)
01/03/201009/12/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT01610791
(ClinicalTrials.gov)
March 201031/5/2012A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll121Phase 3Morocco
267NCT01256736
(ClinicalTrials.gov)
March 201028/10/2010To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid ArthritisProspective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 StudyRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDsJW PharmaceuticalNULLCompleted18 YearsN/ABoth89Phase 3Korea, Republic of
268NCT01034397
(ClinicalTrials.gov)
March 201016/12/2009A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDsA Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll54Phase 4Portugal
269NCT01063062
(ClinicalTrials.gov)
February 28, 20103/2/2010A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll107Phase 3Egypt
270EUCTR2009-011137-26-CZ
(EUCTR)
26/02/201013/10/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2009-011137-26-AT
(EUCTR)
25/02/201004/09/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
272EUCTR2009-011137-26-IT
(EUCTR)
15/02/201002/10/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO -MORE Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073
Product Name: Golimumab
Product Code: SCH900259
Product Name: Golimumab
Product Code: SCH 900259
Shering Plough Research Institute, A division of Schering Plough CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
273EUCTR2007-000830-38-PL
(EUCTR)
08/02/201005/01/2010A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Cimzia®
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3BFrance;Poland;Austria;Germany;Italy
274EUCTR2009-011137-26-BE
(EUCTR)
18/01/201019/10/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
275NCT02731560
(ClinicalTrials.gov)
January 20106/3/2016Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: RituximabProf. Abid Z. FarooqiAga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, RawalpindiCompleted18 Years80 YearsBoth74Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT01034137
(ClinicalTrials.gov)
January 201016/12/2009A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid ArthritisU-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX MonotherapyRheumatoid ArthritisDrug: methotrexate;Drug: placebo MTX;Drug: placebo TCZ;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll317Phase 3Netherlands
277NCT01089023
(ClinicalTrials.gov)
January 20108/3/2010A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisMulticenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll95Phase 4Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
278EUCTR2009-011137-26-IE
(EUCTR)
21/12/200915/09/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
279EUCTR2009-011137-26-FR
(EUCTR)
15/12/200910/09/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
280EUCTR2009-011137-26-DK
(EUCTR)
07/12/200902/11/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2009-011137-26-NL
(EUCTR)
02/12/200931/08/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
282EUCTR2009-009696-34-DE
(EUCTR)
23/11/200914/05/2009A Study in Patients with Rheumatoid ArthritisA Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy Rheumatoid Arthritis
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] - Immune System Diseases [C20]
Product Name: LY2439821
Product Code: LY2439821
INN or Proposed INN: N.A.
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
648Phase 2India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland
283EUCTR2009-012185-32-IT
(EUCTR)
23/11/200925/06/2009Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - NDOpen label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs.
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: Ro487-7533
INN or Proposed INN: RoActemra
ROCHENULLNot RecruitingFemale: yes
Male: yes
Phase 3bItaly
284EUCTR2009-011137-26-SK
(EUCTR)
11/11/200919/11/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
285EUCTR2008-006924-68-HU
(EUCTR)
11/11/200902/09/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2009-013316-12-NL
(EUCTR)
10/11/200921/10/2009A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-EarlyA multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra
Trade Name: Methotrexate 'Lederle' 2,5mg tablets
Roche Nederland B.V.NULLNot RecruitingFemale: yes
Male: yes
Netherlands
287JPRN-UMIN000002687
2009/11/0116/11/2009ENBREL Clinical Outcome in RA patients for Growing Evidence rheumatoid arthritisMTX/MTX+DMARDs group
MTX+ETN group
ETN continuation group
ETN discontinuation group
TAP CorporationNULLComplete: follow-up complete20years-oldNot applicableMale and Female330Not applicableJapan,Asia(except Japan)
288NCT00996203
(ClinicalTrials.gov)
October 31, 200915/10/2009A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)Hoffmann-La RocheNULLCompleted18 YearsN/AAll201Phase 4Russian Federation
289NCT00951275
(ClinicalTrials.gov)
October 31, 200930/7/2009A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)Hoffmann-La RocheNULLCompleted18 YearsN/AAll105Phase 3Italy
290EUCTR2009-011137-26-ES
(EUCTR)
23/10/200906/08/2009 Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE Artritis reumatoide
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2009-011137-26-FI
(EUCTR)
22/10/200925/08/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
292EUCTR2009-011137-26-HU
(EUCTR)
19/10/200902/09/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
293EUCTR2009-011137-26-GB
(EUCTR)
19/10/200918/10/2010An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
294EUCTR2009-012218-30-PT
(EUCTR)
06/10/200912/08/2009A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAITA randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand.Trade Name: RoActemraRoche Farmacêutica Química, Lda.NULLNot RecruitingFemale: yes
Male: yes
Portugal
295EUCTR2009-011137-26-DE
(EUCTR)
05/10/200903/08/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MOREAn open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Schering-Plough Research Institute, A Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT01211834
(ClinicalTrials.gov)
October 200929/9/2010Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD TherapyRheumatoid ArthritisDrug: tocilizumab;Drug: DMARDs;Drug: PlaceboJW PharmaceuticalNULLCompleted18 YearsN/ABoth90Phase 3Korea, Republic of
297NCT00996606
(ClinicalTrials.gov)
October 200915/10/2009A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDsOpen Label, Multicentric Phase IIIb Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Dedicated Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: DMARDs;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll58Phase 3Italy
298EUCTR2006-006373-25-FI
(EUCTR)
21/09/200916/06/2009A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
299EUCTR2008-001847-20-DE
(EUCTR)
08/09/200903/06/2009Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY Rheumatoid Arthritis
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]
Trade Name: RoActemra®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden
300EUCTR2006-006373-25-GB
(EUCTR)
03/09/200916/11/2010A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/AA PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot Recruiting Female: yes
Male: yes
300Phase 2;Phase 3Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT00975130
(ClinicalTrials.gov)
September 200920/8/2009Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)Arthritis, RheumatoidBiological: SC golimumab;Biological: IV golimumabMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll3366Phase 3Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom
302EUCTR2009-011206-42-CZ
(EUCTR)
18/08/200905/06/2009A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including BiologicsA Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Incyte CorporationNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Czech Republic
303EUCTR2008-008338-35-FI
(EUCTR)
13/08/200914/05/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
304NCT00929357
(ClinicalTrials.gov)
August 200925/6/2009Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic TreatmentA Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.Rheumatoid ArthritisDrug: DMARDs or BiologicsPfizerNULLCompleted18 YearsN/AAll156N/ADenmark
305NCT00966875
(ClinicalTrials.gov)
August 200925/8/2009A Study in Patients With Rheumatoid ArthritisA Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD TherapyRheumatoid ArthritisBiological: LY2439821;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years75 YearsAll448Phase 2United States;Argentina;Chile;Germany;India;Korea, Republic of;Peru;Poland;Romania;Russian Federation;Taiwan;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2008-008338-35-DE
(EUCTR)
14/07/200904/05/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;United Kingdom;Czech Republic;Germany;Denmark;Bulgaria;Spain
307JPRN-UMIN000002169
2009/07/0107/07/2009Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis Rheumatoid ArthritisSalazosulfapyridine
Bucillamine
Higashi-Hiroshima Memorial HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female60Phase 4Japan
308EUCTR2008-008337-11-GR
(EUCTR)
25/06/200920/10/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
309EUCTR2008-007788-17-DE
(EUCTR)
24/06/200908/04/2009PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISPHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
611Phase 3Czech Republic;Bulgaria;Germany
310EUCTR2007-000828-40-PL
(EUCTR)
24/06/200912/05/2009A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis.A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3BGermany;France;Italy;Austria;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311EUCTR2008-008337-11-SK
(EUCTR)
22/06/200909/09/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
795Phase 3Slovakia;Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
312EUCTR2008-008337-11-ES
(EUCTR)
19/06/200927/03/2009Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSEstudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Artritis reumatoide RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
313EUCTR2008-008338-35-ES
(EUCTR)
19/06/200927/03/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexatoPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Pfizer, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
314EUCTR2008-008337-11-DK
(EUCTR)
18/06/200915/05/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
315EUCTR2008-008337-11-FI
(EUCTR)
17/06/200924/04/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
795Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2008-008337-11-DE
(EUCTR)
16/06/200907/04/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
795Phase 3Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
317EUCTR2008-008338-35-BG
(EUCTR)
16/06/200922/05/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
318EUCTR2008-008338-35-GB
(EUCTR)
11/06/200909/04/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain
319EUCTR2008-008337-11-GB
(EUCTR)
10/06/200909/04/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;Germany;United Kingdom;Denmark;Spain;Greece;Poland;Sweden
320EUCTR2008-008337-11-PL
(EUCTR)
09/06/200930/04/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
795Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2008-006924-68-GR
(EUCTR)
03/06/200919/11/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
322EUCTR2008-008338-35-DK
(EUCTR)
03/06/200929/04/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
323EUCTR2008-007788-17-BG
(EUCTR)
01/06/200922/05/2009PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
611Phase 3Germany;Czech Republic;Bulgaria
324NCT00848354
(ClinicalTrials.gov)
June 200918/2/2009Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) TherapyA Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARDPfizerAmgenCompleted18 Years69 YearsAll429Phase 4Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela
325NCT00977106
(ClinicalTrials.gov)
June 200918/8/2009TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNFComparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDORheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: placeboHoffmann-La RocheNULLCompleted18 YearsN/AAll103Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326EUCTR2008-008337-11-SE
(EUCTR)
27/05/200923/03/2009PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
327EUCTR2008-008338-35-SK
(EUCTR)
25/05/200909/09/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
328EUCTR2008-007788-17-CZ
(EUCTR)
20/05/200918/03/2009PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
611Phase 3Germany;Czech Republic;Bulgaria
329EUCTR2008-008338-35-CZ
(EUCTR)
20/05/200918/03/2009PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
330EUCTR2008-006924-68-PT
(EUCTR)
18/05/200917/03/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331EUCTR2009-011105-17-IT
(EUCTR)
17/05/200927/03/2009A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia FatigueA single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: Ro 487-7533
INN or Proposed INN: RoActemra
ROCHENULLNot RecruitingFemale: yes
Male: yes
Italy
332NCT00891020
(ClinicalTrials.gov)
May 200929/4/2009A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choiceHoffmann-La RocheNULLCompleted18 YearsN/AAll886Phase 3United States;Puerto Rico;United Kingdom
333NCT00856544
(ClinicalTrials.gov)
May 20093/3/2009A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis MedicationsPhase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDSArthritis, RheumatoidDrug: CP-690,550;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll795Phase 3United States;Australia;Chile;China;Colombia;Croatia;Denmark;Finland;Germany;Greece;Malaysia;Mexico;Poland;Russian Federation;Slovakia;Spain;Sweden;Thailand;United Kingdom;Venezuela
334NCT00902486
(ClinicalTrials.gov)
May 200913/5/2009INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic DrugsA Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including BiologicsRheumatoid ArthritisDrug: INCB028050;Drug: PlaceboIncyte CorporationNULLCompleted18 YearsN/AAll127Phase 2United States;Czechia;Czech Republic
335EUCTR2008-006924-68-CZ
(EUCTR)
28/04/200912/02/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2008-008309-23-FR
(EUCTR)
24/04/200931/03/2009Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDOEtude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Code: RO487-7533/F01-F05
INN or Proposed INN: tolicizumab
ROCHENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
337EUCTR2008-006924-68-FR
(EUCTR)
06/04/200919/03/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Code: RO4877533/F04-F05
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
338EUCTR2008-006924-68-IT
(EUCTR)
03/04/200923/03/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - extension to study MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - extension to study MA21573 Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF therapies.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: TOCILIZUMAB
F. Hoffmann-La RocheNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
339EUCTR2008-006924-68-NL
(EUCTR)
02/04/200909/02/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
340EUCTR2008-000587-17-DE
(EUCTR)
26/03/200917/12/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2008-000587-17-IT
(EUCTR)
12/03/200920/03/2009Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - NDMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti-TNF therapies
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
ROCHENULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
342EUCTR2008-006924-68-GB
(EUCTR)
06/03/200929/04/2009Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom
343NCT00883753
(ClinicalTrials.gov)
March 200917/4/2009An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) TherapyAn Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll934Phase 3Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey
344NCT00687193
(ClinicalTrials.gov)
March 200922/5/2008Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In JapanA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARDArthritis, RheumatoidDrug: Placebo;Drug: CP-690,550PfizerNULLCompleted20 Years70 YearsAll318Phase 2Japan
345NCT00810199
(ClinicalTrials.gov)
March 200916/12/2008A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate TreatmentRandomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placeboHoffmann-La RocheNULLCompleted18 YearsN/AAll556Phase 3United States;Brazil;Croatia;Denmark;Estonia;France;Germany;Greece;Israel;Italy;Latvia;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Sweden;Thailand;United Kingdom;Monaco
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346EUCTR2008-000587-17-HU
(EUCTR)
27/02/200928/11/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
347EUCTR2008-001847-20-GR
(EUCTR)
17/02/200906/03/2009Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. Rheumatoid ArthritisTrade Name: RoActemra®
Product Code: L04AC07
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
348EUCTR2008-006924-68-ES
(EUCTR)
13/02/200919/01/2009Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573 Artritis reumatoide/Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
349EUCTR2008-001847-20-SE
(EUCTR)
02/02/200923/10/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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]
Trade Name: RoActemra®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
350EUCTR2008-001847-20-IT
(EUCTR)
18/01/200918/12/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - NDRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before.
MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Product Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate Lederle 2.5 mg Tablets
INN or Proposed INN: Methotrexate
Product Name: Tocilizumab
Product Code: RO04877533
ROCHENULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351EUCTR2008-000587-17-GR
(EUCTR)
13/01/200930/01/2009Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti- TNF therapies
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab
F. Hoffmann- La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
352EUCTR2008-007225-39-BE
(EUCTR)
06/01/200912/02/2009A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA early active Rheumatoid Arthritis, previously untreated with DMARDS
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]
Trade Name: Ledertrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Salazopyrine
INN or Proposed INN: SULFASALAZINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
University Hospitals LeuvenNULLNot RecruitingFemale: yes
Male: yes
400Phase 4Belgium
353NCT00843778
(ClinicalTrials.gov)
January 20095/1/2009Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity StudyA Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.Rheumatoid ArthritisBiological: Certolizumab PegolUCB PharmaNULLCompleted18 YearsN/AAll131Phase 3Austria;France;Germany;Italy;Poland
354EUCTR2008-001847-20-LV
(EUCTR)
19/12/200829/12/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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]
Trade Name: RoActemra®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden
355EUCTR2008-001847-20-GB
(EUCTR)
19/12/200809/09/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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]
F Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
470Phase 3Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356EUCTR2008-001847-20-NL
(EUCTR)
10/12/200823/10/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAYRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAY Rheumatoid ArthritisProduct Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
357EUCTR2008-001847-20-DK
(EUCTR)
10/12/200821/10/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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]
Trade Name: RoActemra®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
358EUCTR2007-000830-38-DE
(EUCTR)
05/12/200829/09/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3BFrance;Poland;Austria;Germany;Italy
359NCT00810277
(ClinicalTrials.gov)
November 30, 200816/12/2008A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDsAn Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll14Phase 3Finland
360EUCTR2008-001847-20-EE
(EUCTR)
28/11/200813/10/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. Rheumatoid ArthritisTrade Name: RoActemra®
Product Code: L04AC07
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2008-001847-20-FR
(EUCTR)
17/11/200821/10/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: RO04877533/F05/F04
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate
F Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Germany;United Kingdom;Netherlands;Denmark;Estonia;France;Spain;Italy;Greece;Latvia;Sweden
362NCT00783536
(ClinicalTrials.gov)
November 200829/10/2008A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid ArthritisAn Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept + Methotrexate;Drug: DMARDSWyeth is now a wholly owned subsidiary of PfizerNULLWithdrawn18 Years80 YearsBoth402Phase 4Mexico
363NCT00773461
(ClinicalTrials.gov)
October 31, 200815/10/2008A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD TherapyRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: PlaceboHoffmann-La RocheNULLCompleted18 Years70 YearsAll209Phase 3China
364EUCTR2008-000587-17-BE
(EUCTR)
13/10/200819/08/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SureMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-Sure Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
365EUCTR2007-000830-38-AT
(EUCTR)
09/10/200809/09/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3BFrance;Poland;Austria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366EUCTR2007-000830-38-FR
(EUCTR)
07/10/200810/07/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate
UCB Pharma S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3BGermany;France;Italy;Poland;Austria
367EUCTR2008-000587-17-DK
(EUCTR)
22/09/200804/07/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
368EUCTR2008-000587-17-CZ
(EUCTR)
15/09/200820/06/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece
369EUCTR2008-000587-17-IE
(EUCTR)
11/09/200805/06/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab (Actemra)
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
370EUCTR2008-004126-16-FI
(EUCTR)
05/09/200815/07/2008Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDsLocal Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tocilizumab
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Roche OyNULLNot RecruitingFemale: yes
Male: yes
Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT00750880
(ClinicalTrials.gov)
September 200810/9/2008An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll1681Phase 3Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
372NCT00780793
(ClinicalTrials.gov)
September 200827/10/2008Spacing of TNF-blocker Injections in Rheumatoid Arthritis StudyEffect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease ActivityRheumatoid ArthritisDrug: progressive spacing of TNF-blocker injections;Drug: DMARD maintenanceAssistance Publique - Hôpitaux de ParisFrench Society of RheumatologyCompleted18 YearsN/ABoth250Phase 4France
373EUCTR2008-000587-17-FI
(EUCTR)
20/08/200805/06/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
374EUCTR2008-000105-11-DE
(EUCTR)
19/08/200816/05/2008Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid ArthritisEffectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Roche Pharma AGNULLNot RecruitingFemale: yes
Male: yes
Germany
375EUCTR2008-000587-17-FR
(EUCTR)
12/08/200816/07/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tolicizumab Roche
Product Code: RO4877533/F04-F05
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376EUCTR2008-000587-17-NL
(EUCTR)
12/08/200810/09/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
377EUCTR2008-000587-17-PT
(EUCTR)
08/08/200806/06/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SUREMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
378EUCTR2006-006373-25-BG
(EUCTR)
04/08/200814/09/2009A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/AA PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
379EUCTR2008-000587-17-ES
(EUCTR)
22/07/200826/05/2008Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyEstudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Artritis reumatoideRheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab Roche
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
380EUCTR2008-000587-17-SE
(EUCTR)
03/07/200821/05/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381JPRN-UMIN000001281
2008/07/0131/07/2008Strategic reduction of joint destruction in rheumatoid arthritis Rheumatoid arthritisTNF-inhibitors plus MTX
TNF-inhibitors are used for 54 weeks and exchange among them is approved

MTX
MTX is used for 54 weeks and addition of the other DMARD is approved
School of Medicine, University of Occupational and Environmental Health, JapanNULLNot applicableNot applicableMale and Female120Not selectedJapan
382JPRN-UMIN000002421
2008/07/0104/09/2009Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis rheumatoid arthritistocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab
AA amyloidosis clinical research conferenceNULLRecruiting20years-oldNot applicableMale and Female40Not selectedJapan
383EUCTR2007-000830-38-IT
(EUCTR)
30/06/200821/07/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - NDA Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - ND rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A. (Casa Madre)NULLNot RecruitingFemale: yes
Male: yes
132Phase 3BGermany;France;Italy;Poland;Austria
384EUCTR2008-000587-17-AT
(EUCTR)
19/06/200809/05/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SUREMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
385EUCTR2008-000587-17-GB
(EUCTR)
18/06/200818/04/2008Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386EUCTR2007-000886-40-IT
(EUCTR)
04/06/200821/03/2008Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
sanofi-aventis GroupeNULLNot RecruitingFemale: yes
Male: yes
200Portugal;Italy
387NCT00674362
(ClinicalTrials.gov)
June 20085/5/2008Rheumatoid Arthritis (RA) Moderate to Low Disease Activity StudyA Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid ArthritisRheumatoid ArthritisBiological: Certolizumab pegol;Biological: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll194Phase 3Austria;France;Germany;Italy;Poland
388EUCTR2007-000828-40-DE
(EUCTR)
27/05/200810/01/2008A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3BGermany;France;Italy;Poland;Austria
389EUCTR2007-000828-40-IT
(EUCTR)
15/05/200814/07/2008A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - NDA Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND Rheumatoid arthritis with moderate to low disease activity
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB S.A. (Casa Madre)NULLNot RecruitingFemale: yes
Male: yes
170Phase 3BGermany;France;Italy;Poland;Austria
390EUCTR2007-000828-40-FR
(EUCTR)
26/02/200811/12/2007A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3BGermany;France;Italy;Poland;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391EUCTR2006-006373-25-GR
(EUCTR)
26/02/200820/09/2007A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
392EUCTR2007-000828-40-AT
(EUCTR)
21/02/200831/03/2008A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3BGermany;France;Italy;Poland;Austria
393EUCTR2007-002066-35-IT
(EUCTR)
13/02/200807/09/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - NDA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND CP-690,550 is being developed as a disease-modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: CP-690,550
Product Name: CP-690,550
Trade Name: Humira
INN or Proposed INN: Adalimumab
PFIZERNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BHungary;Germany;Czech Republic;Bulgaria;Italy;Greece
394NCT00596206
(ClinicalTrials.gov)
December 20074/1/2008Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid ArthritisAssessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-PatientsArthritis, RheumatoidDrug: leflunomideSanofiNULLCompleted18 YearsN/ABoth124Phase 3Czech Republic;Italy;Korea, Republic of;Portugal;Romania
395EUCTR2006-006373-25-CZ
(EUCTR)
14/11/200720/09/2007A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396EUCTR2007-000886-40-PT
(EUCTR)
09/11/200707/08/2007Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
sanofi-aventis groupeNULLNot RecruitingFemale: yes
Male: yes
200Portugal;Italy
397EUCTR2007-002945-18-CZ
(EUCTR)
15/10/200727/08/2007A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDsA double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
Genmab A/SNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Czech Republic
398NCT00531817
(ClinicalTrials.gov)
October 200718/9/2007A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll619Phase 3United States;Puerto Rico
399EUCTR2007-000886-40-CZ
(EUCTR)
17/07/200730/05/2007Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
sanofi-aventis groupeNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Czech Republic;Italy
400NCT00664716
(ClinicalTrials.gov)
July 200721/4/2008Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) PatientsAssessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.Rheumatoid ArthritisBiological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfaBiogen IdecNULLCompleted18 Years75 YearsBoth391Phase 2Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401EUCTR2006-005466-39-HU
(EUCTR)
25/06/200722/03/2007A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD TherapyA Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
380Phase 2bHungary;United Kingdom
402NCT00422227
(ClinicalTrials.gov)
June 200711/1/2007Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific RegionA Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomideWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll300Phase 4Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
403NCT00521924
(ClinicalTrials.gov)
June 200727/8/2007Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapyRheumatoid ArthritisBiological: infliximab;Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.Merck Sharp & Dohme Corp.AESCA Pharma GmbHTerminated19 Years65 YearsAll8Phase 3Austria
404EUCTR2006-006373-25-SE
(EUCTR)
04/05/200716/03/2007A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UKNULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
405EUCTR2006-006373-25-SK
(EUCTR)
20/04/200703/04/2007A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/AA PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UKNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406EUCTR2006-005466-39-GB
(EUCTR)
12/04/200707/01/2007A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD TherapyA Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Biogen Idec LtdNULLNot Recruiting Female: yes
Male: yes
380Phase 2Hungary;United Kingdom
407EUCTR2006-006373-25-ES
(EUCTR)
23/03/200724/01/2007ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR).CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
408EUCTR2006-003146-41-DE
(EUCTR)
08/03/200723/11/2006A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARDA CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD Musculoskeletal disorders
MedDRA version: 8.1;Level: LLT;Classification code 10048592;Term: Musculoskeletal disorder
Trade Name: Humira
Product Name: HUMIRA
INN or Proposed INN: Adalimumab
Trade Name: Metex
Product Name: Metex
Charité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical ImmunologyNULLNot RecruitingFemale: yes
Male: yes
Germany
409NCT00913432
(ClinicalTrials.gov)
March 20073/6/2009Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid ArthritisA 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF AlphaRheumatoid ArthritisDrug: masitinibAB ScienceNULLCompleted18 YearsN/AAll20Phase 2NULL
410EUCTR2006-006373-25-AT
(EUCTR)
15/02/200712/02/2007A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UKNULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411EUCTR2006-006186-16-NL
(EUCTR)
30/01/200716/07/2007IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVEDIMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED rheumatoid arthritis and undifferentiated arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Methotrexate
Product Code: MTX
INN or Proposed INN: METHOTREXATE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Product Name: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Trade Name: hydroxychloroquine
Product Name: hydroxychloroquine
Product Code: HCQ
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
Trade Name: Humira
Product Name: adalimumab
Leiden University Medical Center, department of rheumatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
412NCT00484289
(ClinicalTrials.gov)
December 20067/6/2007A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid ArthritisA Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD FailuresRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNULLCompleted20 YearsN/AAll217Phase 3Japan
413EUCTR2004-001490-26-EE
(EUCTR)
01/09/200608/03/2006A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RAA MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA RHEUMATOID ARTHRITISTrade Name: Persantin 100 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Dipyridamole and Amoxapine
Trade Name: Defanyl 50 and 100 mg
Product Name: N/A
Product Code: CRx-150
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
72United Kingdom;Estonia
414NCT01308255
(ClinicalTrials.gov)
September 20063/3/2011Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acidUniversity of LeedsNULLCompleted18 Years80 YearsAll112Phase 4United Kingdom
415NCT02006706
(ClinicalTrials.gov)
August 10, 20065/12/2013A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD TherapyAn Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment FailureRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisoloneHoffmann-La RocheNULLCompleted18 Years80 YearsAll15Phase 3Serbia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416EUCTR2004-001930-18-EE
(EUCTR)
17/04/200619/01/2006A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RAA MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA RHEUMATOID ARTHRITISTrade Name: Persantin 100 mg and
Product Name: N/A
Product Code: CRx-102
INN or Proposed INN: prednisolone & dipyridamole
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
60Estonia
417EUCTR2004-005102-68-CZ
(EUCTR)
14/04/200614/04/2006A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy
418EUCTR2004-004995-35-DK
(EUCTR)
10/04/200620/09/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISProduct Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;Germany;United Kingdom;Denmark;Italy
419EUCTR2005-005013-37-GB
(EUCTR)
06/04/200620/01/2006A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEAA multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA Early Rheumatoid ArthritisUniversity of LeedsNULLNot Recruiting Female: yes
Male: yes
112Phase 4United Kingdom
420EUCTR2004-004995-35-GB
(EUCTR)
24/02/200616/03/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISTrade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421EUCTR2005-003436-21-CZ
(EUCTR)
15/02/200607/11/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib
Dainippon Sumitomo Pharma Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Germany;United Kingdom;Czech Republic
422NCT00296257
(ClinicalTrials.gov)
February 200622/2/2006Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.Rheumatoid Arthritis (RA)Drug: SMP-114Dainippon Sumitomo Pharma Europe LTd.NULLTerminated18 YearsN/ABoth312Phase 2Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom
423EUCTR2005-003436-21-DE
(EUCTR)
18/01/200624/10/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib
Dainippon Sumitomo Pharma Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Czech Republic;United Kingdom;Germany
424NCT02922192
(ClinicalTrials.gov)
January 200628/9/2016Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisIncidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisRheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing SpondylitisDrug: TNF-a antagonists, non-TNFs, DMARD non-biologicsBiologics & Biosimilars Collective Intelligence ConsortiumHealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC;HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMCActive, not recruiting18 YearsN/ABoth100000N/ANULL
425NCT00254293
(ClinicalTrials.gov)
January 200615/11/2005Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)Rheumatoid ArthritisDrug: Abatacept or Placebo (both as IV & SC Solution);Drug: Abatacept or Placebo (both as IV & SC solution);Drug: AbataceptBristol-Myers SquibbNULLCompleted18 YearsN/AAll87Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426EUCTR2005-003436-21-HU
(EUCTR)
15/12/200511/10/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073
Product Name: SMP-114
Product Code: SMP-114
Sumitomo Pharmaceuticals Europe LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Czech Republic;Germany;United Kingdom
427EUCTR2004-005210-37-FI
(EUCTR)
17/11/200514/03/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
428EUCTR2004-005102-68-BE
(EUCTR)
15/11/200525/07/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008) RHEUMATOID ARTHRITIS,NOSTrade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
429EUCTR2004-004995-35-IT
(EUCTR)
08/11/200502/02/2007A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARDA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment.
MedDRA version: 6.1;Level: PT;Classification code 10039073
INN or Proposed INN: Paroxetine
INN or Proposed INN: Paroxetine
Trade Name: Prednisolene tablets BP 1 mg
INN or Proposed INN: Prednisolone
COMBINATORX, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 2Czech Republic;Germany;United Kingdom;Denmark;Italy
430EUCTR2004-005102-68-IT
(EUCTR)
03/11/200504/11/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic OptionsA Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options Rheumatiod arthritis
MedDRA version: 6.1;Level: HLT;Classification code 10039075
Product Name: abatacept
Product Code: BMS-188667
BRISTOL-M.SQUIBBNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT00292422
(ClinicalTrials.gov)
November 200515/2/2006Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid ArthritisA Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD TherapyRheumatoid ArthritisDrug: BG9924Biogen IdecNULLCompleted18 Years75 YearsBoth50Phase 2United States;Poland
432EUCTR2005-003436-21-GB
(EUCTR)
26/10/200505/09/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib
Dainippon Sumitomo Pharma Europe LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Czech Republic;Germany;United Kingdom
433EUCTR2004-004995-35-AT
(EUCTR)
16/10/200509/11/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISTrade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom
434EUCTR2004-005102-68-DE
(EUCTR)
15/09/200515/07/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;United Kingdom;Germany;Belgium;Spain;Ireland;Italy
435EUCTR2004-005102-68-GB
(EUCTR)
01/09/200527/05/2005 A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RHEUMATOID ARTHRITIS,NOSBristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436EUCTR2004-004995-35-CZ
(EUCTR)
30/08/200530/08/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISTrade Name: Prednisolone Tablets BP 1 mg
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Germany;United Kingdom;Czech Republic;Denmark;Italy
437EUCTR2004-005102-68-ES
(EUCTR)
16/08/200517/06/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Ireland;Spain;Italy
438EUCTR2004-005102-68-IE
(EUCTR)
05/08/200502/06/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
439EUCTR2004-004995-35-DE
(EUCTR)
14/07/200517/03/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISProduct Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: Prednisolone
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: paroxetine
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;United Kingdom;Germany;Denmark;Italy
440EUCTR2004-005210-37-CZ
(EUCTR)
01/07/200530/06/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Germany;Czech Republic;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT00503425
(ClinicalTrials.gov)
June 30, 200517/7/2007A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha AgentRheumatoid ArthritisDrug: Rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/AAll215Phase 3Israel
442EUCTR2004-005210-37-DE
(EUCTR)
04/05/200510/03/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
443EUCTR2004-005210-37-SE
(EUCTR)
26/04/200510/03/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
444NCT00124982
(ClinicalTrials.gov)
April 200530/6/2005Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF TherapyA Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic OptionsRheumatoid ArthritisDrug: Abatacept;Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD);Drug: Anti-Tumor Necrosing Factor (TNF) TherapyBristol-Myers SquibbNULLCompleted18 YearsN/AAll1286Phase 3United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada
445NCT00106574
(ClinicalTrials.gov)
April 200525/3/2005A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD TherapyRheumatoid ArthritisDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth1220Phase 3United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446EUCTR2004-005210-37-ES
(EUCTR)
29/03/200504/11/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
447NCT00747214
(ClinicalTrials.gov)
November 20043/9/2008A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RAA Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RARheumatoid ArthritisDrug: CRx-102;Drug: Placebo;Drug: DMARD TherapyZalicusNULLCompleted18 YearsN/AAll59Phase 2NULL
448EUCTR2004-001490-26-GB
(EUCTR)
15/09/200401/06/2005A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RAA SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA RHEUMATOID ARTHRITISTrade Name: Asendis 50 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Amoxapine & dipyridamole
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
Estonia;United Kingdom
449NCT00831922
(ClinicalTrials.gov)
September 200428/1/2009Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid ArthritisA Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)Rheumatoid ArthritisDrug: masitinib (AB1010)AB ScienceNULLCompleted18 YearsN/AAll43Phase 2NULL
450NCT00117091
(ClinicalTrials.gov)
September 200430/6/2005Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Anakinra (Kineret®)AmgenNULLCompleted18 YearsN/ABothPhase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT00089921
(ClinicalTrials.gov)
July 200417/8/2004SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving MethotrexateA 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than HydroxychloroquineArthritis, RheumatoidDrug: SCIO-469;Drug: PlaceboScios, Inc.NULLCompleted18 YearsN/ABoth302Phase 2United States
452NCT00162201
(ClinicalTrials.gov)
October 20039/9/2005An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF TherapyAn Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF TherapyRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNULLCompleted18 YearsN/AAll16Phase 1United Kingdom
453NCT00548834
(ClinicalTrials.gov)
June 200315/10/2007Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisEfficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARDRheumatoid ArthritisDrug: CDP870UCB PharmaNULLCompleted18 Years75 YearsBoth220Phase 3NULL
454NCT00563849
(ClinicalTrials.gov)
May 200321/11/2007Leflunomide + Methotrexate in Rheumatoid ArthritisAn Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.Rheumatoid ArthritisDrug: LeflunomideSanofiNULLCompleted18 Years75 YearsBoth74Phase 4Korea, Republic of
455NCT02214888
(ClinicalTrials.gov)
May 200312/8/2014Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets in Patients With Active Rheumatoid ArthritisA 12 Week Double-blind, Randomized, Placebo-controlled Trial to Investigate Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets at Doses of 50 and 70 mg Administered Twice a Day in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARDArthritis, RheumatoidDrug: BIRB 796 BS, low dose;Drug: BIRB 796 BS, high dose;Drug: PlaceboBoehringer IngelheimNULLTerminated18 Years75 YearsBoth170Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT00908089
(ClinicalTrials.gov)
March 200322/5/2009TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid ArthritisUse of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placeboHelsinki UniversitySeinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-HameActive, not recruiting18 Years60 YearsBoth100Phase 4Finland
457NCT00048581
(ClinicalTrials.gov)
December 20022/11/2002Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) TherapyRheumatoid ArthritisDrug: Abatacept;Drug: PlaceboBristol-Myers SquibbNULLCompleted18 YearsN/AAll738Phase 3United States
458NCT00764725
(ClinicalTrials.gov)
December 20021/10/2008Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTXRheumatoid ArthritisDrug: conventional DMARD combination;Biological: MTX plus anti-TNFKarolinska InstitutetNULLCompleted18 YearsN/ABoth487Phase 4NULL
459NCT00116727
(ClinicalTrials.gov)
October 200230/6/2005Rheumatoid Arthritis DMARD Intervention and UtilizationStudyRheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)Rheumatoid ArthritisDrug: ENBREL®AmgenImmunex Corporation;Wyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/ABoth5103N/AUnited States
460NCT00116714
(ClinicalTrials.gov)
October 200130/6/2005Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudyRheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)Rheumatoid ArthritisDrug: DMARDAmgenImmunex Corporation;Wyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/ABoth4968N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT02209779
(ClinicalTrials.gov)
May 20015/8/2014Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid ArthritisA Randomised, Parallel, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of Different Doses (5, 10, 20 and 30 mg) of BIRB 796 BS Administered Twice a Day Orally Over 4 Weeks in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARDArthritis, RheumatoidDrug: BIBR 796 BS;Drug: PlaceboBoehringer IngelheimNULLCompleted18 Years75 YearsBoth167Phase 2NULL
462NCT00579878
(ClinicalTrials.gov)
December 199917/12/2007Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid ArthritisTriple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-HydroxychloroquineUniversity of NebraskaNULLCompleted19 Years80 YearsAll69Phase 3United States
463EUCTR2012-001145-40-Outside-EU/EEA
(EUCTR)
07/03/2012Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritisOpen-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320NULLNAFemale: yes
Male: yes
783Canada;United States
464EUCTR2019-000868-18-LT
(EUCTR)
19/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of