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

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
1592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04196868December 3, 20205/12/2019Methotrexate and Metformin in Rheumatoid Arthritis PatientsRandomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis PatientsArthritis, RheumatoidDrug: Metformin treatment;Other: Placebo;Drug: Methotrexate treatmentUniversity Hospital, BordeauxMinistry for Health and Solidarity, FranceRecruiting18 YearsN/AAll128Phase 2France
2NCT04649697December 1, 202026/10/2020Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis PatientsEvaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical TrialRheumatoid ArthritisDrug: Rebamipide;Drug: Nanoparticulated Rebamipide;Drug: Clobetasol PropionateCairo UniversityNULLNot yet recruiting20 Years70 YearsAll39Phase 3NULL
3NCT04470453November 20209/7/2020Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological DrugAssociation Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological DrugRheumatoid ArthritisBiological: Blood sample;Diagnostic Test: CRQCentre Hospitalier Universitaire de Saint EtienneNULLNot yet recruiting18 YearsN/AAll60Phase 4France
4EUCTR2020-000658-83-BG21/10/202007/10/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexateA randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate Rheumatoid arthritis
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2Poland;Ukraine;Georgia;Bulgaria
5NCT04577781October 12, 202030/9/2020A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to MethotrexateArthritis, RheumatoidDrug: GLPG3970;Drug: PlaceboGalapagos NVNULLRecruiting18 Years64 YearsAll25Phase 2Georgia;Poland;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04311567October 7, 20205/3/2020Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung DiseaseEffects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV TrialRheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILDDrug: Tofacitinib;Drug: MethotrexateVastra Gotaland RegionGöteborg UniversityNot yet recruiting18 Years80 YearsAll48Phase 4Sweden
7JPRN-jRCTs04120004802/10/202002/10/2020Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-stateCertolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study Rheumatoid arthritis1) MTX*
- Continued group:
Continued at a stable dose and interval throughout the cours of the study.
Folic acid is continued if concomitantly used.
- Withdrawn group:
Week 0 to 12
Reduced after registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Kojima ToshihisaNULLRecruiting>= 20age oldNot applicableBoth114N/AJapan
8ChiCTR20000376752020-10-012020-08-30Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1''Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1'' Rheumatoid arthritiscontrol group:Methotrexate;experimental group:Qianghuo Dihuang Decoction + Methotrexate;Shanghai Traditional Chinese Medicine HospitalNULLRecruitingBothcontrol group:72;experimental group:72;China
9EUCTR2019-002205-22-FR01/10/202013/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
10EUCTR2019-002676-14-BG20/08/202027/05/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-002205-22-DE12/08/202007/07/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
12NCT04413617July 29, 202019/5/2020TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATEA 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATERheumatoid ArthritisDrug: PF-06650833;Drug: PF-06651600;Drug: TofacitinibPfizerNULLRecruiting18 Years70 YearsAll450Phase 2Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine
13EUCTR2019-002676-14-CZ07/07/202011/05/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
14EUCTR2019-002676-14-HU18/06/202014/04/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
15EUCTR2019-002676-14-SE01/06/202014/04/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-002205-22-GB01/05/202007/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
17EUCTR2019-002205-22-ES06/04/202023/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
18EUCTR2019-002205-22-PL29/03/202007/02/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom
19NCT04247815March 16, 202016/1/2020Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RAA Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: ATI-450;Drug: Placebo oral tablet;Drug: MethotrexateAclaris Therapeutics, Inc.NULLActive, not recruiting18 Years70 YearsAll19Phase 2United States
20EUCTR2019-003700-12-FR13/03/202004/06/2020Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patientsAssociation between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug rheumatoid arthritis
MedDRA version: 21.0Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Methotrexate
Product Code: MTX
Other descriptive name: METHOTREXATE DISODIUM
Product Code: bDMARD
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: CERTOLIZUMAB PEGOL
INN or Proposed INN: GOLIMUMAB
CHU Saint-EtienneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21JPRN-jRCT104119012509/03/202009/03/2020PRECIOUS-B studyPatient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study Rheumatoid arthritis1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Takahashi NobunoriNULLPending>= 20age oldNot applicableBoth51N/AJapan
22EUCTR2018-004558-30-PT03/02/202021/05/2019A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. rheumatoid arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Ledertrexato
Product Name: Metotrexato
Product Code: Metotrexato
INN or Proposed INN: metotrexato
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Metex Pen
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez DíazNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
186Phase 4Portugal;Spain
23EUCTR2019-000284-24-CZ03/02/202017/10/2019A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS. Moderately to severely active Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 4United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina
24NCT04230213January 13, 202014/1/2020A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid ArthritisA RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITISRheumatoid ArthritisDrug: PF-06410293;Drug: adalimumabPfizerNULLRecruiting18 Years70 YearsAll420Phase 3United States;Bosnia and Herzegovina;Bulgaria;Czechia;Lithuania;Poland;Russian Federation;Serbia;South Africa;Ukraine
25EUCTR2019-004179-38-SE10/01/202019/11/2019Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritisEffects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA Patients with early active rheumatoid arthritis
MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Västra GötalandsregionenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
145 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesSweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-000284-24-LT18/12/201907/11/2019A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS. Moderately to severely active Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina
27EUCTR2019-000797-39-GB22/11/201910/06/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation
28EUCTR2018-004287-56-FR21/11/201931/01/2020Methotrexate and Metformin in rheumatoid arthritis patientsRandomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2 rheumatoid arthritis (RA)
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]
CHU de BordeauxNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance
29NCT04227366November 19, 201925/12/2019Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisAn International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: BCD-089;Biological: Placebo;Drug: MethotrexatBiocadNULLActive, not recruiting18 YearsN/AAll150Phase 3Russian Federation
30EUCTR2019-000797-39-PL18/11/201915/07/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2019-000797-39-ES14/11/201909/07/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
32NCT04038970November 8, 201929/7/2019Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateA Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving MethotrexateRheumatoid ArthritisBiological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: MethotrexateJiangsu Alphamab Biopharmaceuticals Co., LtdNULLRecruiting18 YearsN/AAll141Phase 2China
33NCT04170504November 201914/11/2019Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid ArthritisEfficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled TrialRheumatoid ArthritisDrug: Qing Re Huo Xue (QRHX);Drug: Methotrexate;Drug: dummy Qing Re Huo Xue (QRHX)Guang'anmen Hospital of China Academy of Chinese Medical SciencesNULLNot yet recruiting18 YearsN/AAll204Phase 2/Phase 3NULL
34EUCTR2019-000797-39-HU24/10/201928/10/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China
35EUCTR2019-000797-39-LT11/10/201919/07/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04120831October 7, 20194/10/2019TOLERA: Tolerance Enhancement in RASequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing MethotrexateRheumatoid ArthritisDrug: Abatacept InjectionUniversity of Erlangen-Nürnberg Medical SchoolNULLRecruiting18 YearsN/AAll20Phase 2Germany
37EUCTR2019-000797-39-CZ19/09/201918/09/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China
38EUCTR2018-004677-27-BE16/09/201925/03/2019Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. Rheumatoid Arthritis
MedDRA version: 21.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
AbivaxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Hungary;Belgium
39EUCTR2019-000797-39-LV13/09/201925/06/2019Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
1700Phase 3United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
40NCT04136262September 1, 201921/10/2019Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid ArthritisTripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled TrialRheumatoid ArthritisDrug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF)Guang'anmen Hospital of China Academy of Chinese Medical SciencesNULLRecruitingN/AN/AFemale300Phase 2/Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41JPRN-JapicCTI-19492826/8/201922/08/2019-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 Rheumatoid ArthritisIntervention name : methotrexate
INN of the intervention : methotrexate
Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg.
Control intervention name : methotrexate
INN of the control intervention : methotrexate
Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.
medac GmbHNULLcomplete2075BOTH100Japan
42NCT04179513August 15, 201925/11/2019A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis PatientsPhase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose GroupsRheumatoid ArthritisBiological: GB224 10mg;Biological: GB224 20mgGenor Biopharma Co., Ltd.NULLRecruiting18 Years45 YearsAll24Phase 1China
43EUCTR2018-004677-27-HU25/07/201925/07/2019Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. Rheumatoid Arthritis
MedDRA version: 21.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
AbivaxNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noHungary
44ChiCTR19000242612019-07-152019-07-03Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in ChinaEfficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China rheumatoid arthritisA:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week);The Second Hospital of Shanxi Medical UniversityNULLPending1865BothA:30;B:30;China
45EUCTR2016-003682-26-PL11/07/201917/05/2018Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid ArthritisA Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis Early Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CF101
Product Code: CF101
INN or Proposed INN: Piclidenoson
Other descriptive name: IB-MECA
Product Name: CF101
Product Code: CF101
INN or Proposed INN: Piclidenoson
Other descriptive name: IB-MECA
Product Name: METHOTREXATE
Product Code: METHOTREXATE
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Can-Fite BioPharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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46NCT04464642July 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
47NCT03813199July 4, 201915/1/2019Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid ArthritisPhase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfa) Therapy, or Intolerance to Anti-Tnfa TherapyRheumatoid ArthritisDrug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: MethotrexateAbivax S.A.NULLRecruiting18 Years75 YearsAll60Phase 2Belgium;Czechia;France;Hungary;Poland
48EUCTR2018-003877-91-DE13/06/201926/02/2019B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapySequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA Active rheumatoid arthritis with ACPA antibodies failing methotrexate
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Universitätsklinikum ErlangenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Germany
49NCT03980483May 16, 201915/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateArthritis, RheumatoidBiological: GSK3196165;Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acidGlaxoSmithKlineIqvia Pty LtdRecruiting18 YearsN/AAll1500Phase 3United States;Argentina;Canada;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom
50ChiCTR20000325342019-05-152020-05-01Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control studyPharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study Rheumatoid arthritisExperimental group:Anbainuo plus methotrexate;Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine;The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.NULLCompletedBothExperimental group:47;Control group:43;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
51NCT03944096April 30, 20198/5/2019Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to MethotrexateEfficacy and Safety of Faecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate: a 24-week, Double-Blind, Randomised TrialRheumatoid ArthritisProcedure: FMT+MTXPeking Union Medical College HospitalNULLRecruiting18 Years65 YearsAll30Phase 2China
52EUCTR2018-002202-31-BG27/03/201930/11/2018A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid ArthritisA Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BAT1806
INN or Proposed INN: BAT1806
Other descriptive name: TOCILIZUMAB
Trade Name: RoActemra
Product Name: RoActerma
INN or Proposed INN: RoActemra
Other descriptive name: TOCILIZUMAB
Bio-Thera Solutions, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
612Phase 3Poland;Ukraine;Georgia;Bulgaria;China
53ChiCTR19000216862019-03-152019-03-05A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritisA observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis Rheumatoid arthritisCase Series:IGU combined with MTX ;Nanjing Drum Tower HospitalNULLPending1870BothCase Series:30;China
54NCT03813771March 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
55NCT03737708February 13, 20198/11/2018A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical TrialRheumatoid Arthritis (RA)Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abataceptAstellas Pharma Korea, Inc.NULLCompleted19 Years75 YearsAll22Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
56EUCTR2018-001690-25-LT08/02/201929/08/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe Active Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
648Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria
57NCT03830203December 19, 201822/1/2019Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to MethotrexateA Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to MethotrexateRheumatoid ArthritisDrug: BAT1806;Drug: Actemra(EU-licensed)Bio-Thera SolutionsNULLActive, not recruiting18 YearsN/AAll621Phase 3China
58EUCTR2018-001690-25-PL11/12/201825/09/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe Active Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
564Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Korea, Republic of;Bosnia and Herzegovina
59NCT04204603November 30, 201817/12/2019A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to MethotrexateA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisDrug: CKD-506;Drug: PlaceboChong Kun Dang PharmaceuticalNULLCompleted18 Years65 YearsAll122Phase 2Czechia;Georgia;Poland;Russian Federation;Ukraine
60NCT03789292November 26, 201827/12/2018A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisBiological: CT-P17 SC;Biological: Humira SCCelltrionNULLActive, not recruiting18 Years75 YearsAll564Phase 3Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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61NCT03852888November 14, 20187/2/2019Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant PatientsKinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant PatientsRheumatoid ArthritisBiological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate levelCHU de ReimsNULLRecruiting18 YearsN/AAll60N/AFrance
62EUCTR2018-001690-25-HU13/11/201814/08/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe Active Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
564Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina
63NCT03707535November 12, 201812/10/2018To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: CT-P13;Biological: RemicadeCelltrionNULLActive, not recruiting18 Years75 YearsAll270Phase 3China
64EUCTR2018-001690-25-BG05/11/201819/09/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe Active Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
648Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria;Korea, Republic of
65ChiCTR19000260792018-10-252019-09-20Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical studyWangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study Rheumatoid ArthritisExperimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets;Longhua Hospital Shanghai University of Traditional Chinese MedicineNULLRecruiting1870BothExperimental group:60;Control group:60;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
66EUCTR2018-001377-24-CZ09/10/201814/10/2019Not available.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate 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]
Chong Kun Dang Pharmaceutical Corporation (CKD)NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Poland;Ukraine;Russian Federation;Georgia
67JPRN-JapicCTI-18403102/10/201809/07/2018A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) TherapyA Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy Rheumatoid Arthritis (RA)Intervention name : TS-152
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection every 4 weeks
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Taisho Pharmaceutical co., LTDNULLcomplete20BOTH135Phase 3Japan
68NCT03660059September 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
69JPRN-JapicCTI-18402904/9/201809/07/2018A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) TherapyA Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy Rheumatoid Arthritis (RA)Intervention name : TS-152
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection every 4 weeks
Control intervention name : Placebo
INN of the control intervention : Placebo
Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain
Taisho Pharmaceutical co., LTDNULLcomplete2075BOTH370Phase 2/3Japan
70NCT03605251August 30, 20183/7/2018Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: PlacebosTaiho Pharmaceutical Co., Ltd.NULLCompleted20 Years64 YearsAll91Phase 2Japan
No.TrialIDDate_
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71EUCTR2015-004386-91-PL26/08/201820/07/2016Study 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: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
72NCT03535519August 7, 201814/5/2018Rheumatoid Arthritis Response to MethotrexateRheumatoid Arthritis Ultrasound Response to MethotrexateRheumatoid ArthritisDrug: MethotrexateJuan Carlos NietoNordic Pharma SASRecruiting18 YearsN/AAll50Spain
73NCT04066803August 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
74NCT03445871July 2, 201820/2/2018Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable MethotrexateAssociation Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable MethotrexateRheumatoid ArthritisBiological: Blood sample;Diagnostic Test: CRQCentre Hospitalier Universitaire de Saint EtienneNULLCompleted18 YearsN/AAll60Phase 4France
75NCT03589833July 20185/7/2018Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RAEffectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid ArthritisArthritis, RheumatoidDrug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: YisaipuPeking Union Medical College HospitalNULLUnknown status18 Years65 YearsAll504Phase 2China
No.TrialIDDate_
enrollment
Date_
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76NCT02885597July 201818/8/2016Juanbi Pill for Rheumatoid ArthritisJuanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical TrialsJuanbi Pill;Rheumatoid ArthritisDrug: Juanbi pill;Drug: Juanbi pill placebo;Drug: MethotrexateCui xuejunShanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicineUnknown status18 Years80 YearsAll120Phase 2/Phase 3China
77NCT03173040July 201830/5/2017The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid ArthritisThe Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical TrialNiu Bang Zi Pill;Rheumatoid ArthritisDrug: NiuBangZi pill or NiuBangZi pill placeboCui xuejunShanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Seventh People's HospitalUnknown status18 Years80 YearsAll100Phase 2/Phase 3China
78EUCTR2016-002344-16-GB28/06/201829/11/2017Targeted 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
106 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom
79NCT03649061June 8, 201830/7/2018COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RAEffectiveness 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 TrialArthritis, RheumatoidDrug: Etanercept 50 MG/ML;Drug: Leflunomide 10 milligram (MG)P. VerschuerenBelgium Health Care Knowledge CentreActive, not recruiting18 YearsN/AAll284Phase 4Belgium
80NCT03535402June 1, 20189/5/2018Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to BiologicsMeasurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.Rheumatoid ArthritisDrug: SarilumabGaylis, Norman B., M.D.NULLActive, not recruiting18 YearsN/AAll20Phase 3United States
No.TrialIDDate_
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PhaseCountries
81NCT03522415May 28, 201829/4/2018Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to MethotrexateModerately to Severely Active Rheumatoid ArthritisDrug: HLX01;Drug: Methotrexate(MTX)Shanghai Henlius BiotechNULLCompleted18 Years75 YearsAll275Phase 3China
82NCT03492658May 17, 20183/4/2018Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA).Rheumatoid Arthritis;Rheumatic DiseasesDrug: Abatacept;Drug: MethotrexateLeiden University Medical CenterNULLRecruiting18 YearsN/AAll46Phase 4Netherlands
83EUCTR2017-004054-41-BE07/05/201815/03/2018COBRA-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
440 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesBelgium
84NCT03505008April 18, 201816/4/2018Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and TaiwanMIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) StudyRheumatoid ArthritisDrug: Methotrexate;Drug: AdalimumabKeio UniversityEisai Co., Ltd.Active, not recruiting18 YearsN/AAll300Phase 4Japan;Korea, Republic of;Taiwan
85JPRN-jRCT103118008818/04/201818/01/2019MIRACLE StudyMIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study Rheumatoid Arthritis
Rheumatoid Arthritis
Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period).
To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle.
If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1).
If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3).
The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week.
Subjects in whom MTX at a dosage >=
Kaneko YukoEisai Co., Ltd.Not Recruiting>= 18age oldNot applicableBoth300South Korea;Taiwan;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
86JPRN-UMIN0000305842018/04/1827/12/2017MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) StudyMIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study Rheumatoid ArthritisStudy treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1).
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated.
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage
Keio University School of MedicineDivision of Rheumatology, Department of Internal MedicineEisai Co., Ltd.Complete: follow-up continuing18years-oldNot applicableMale and Female300Not selectedJapan,Asia(except Japan)
87NCT03478111March 30, 201816/3/2018CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid ArthritisA Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to RemicadeRheumatoid ArthritisDrug: CMAB008;Drug: MTX;Drug: RemicadeShanghai Biomabs Pharmaceutical Co., Ltd.NULLCompleted18 YearsN/AAll390Phase 3China
88NCT03449758March 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
89EUCTR2017-004348-39-FR15/02/201816/01/2018Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patientsAssociation between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU rheumatoid arthritis
MedDRA version: 20.0Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: methotrexate
Product Code: 1
CHU Saint-EtienneNULLNot RecruitingFemale: yes
Male: yes
60Phase 4France
90EUCTR2017-002878-38-NL07/02/201812/09/2017Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid ArthritisAbatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis
MedDRA version: 20.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Orencia 125 mg
INN or Proposed INN: ABATACEPT
Leiden University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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agemin
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PhaseCountries
91NCT02795299January 20182/5/2016Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid ArthritisPhase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa AntagonistRheumatoid ArthritisDrug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PlaceboBird Rock Bio, Inc.Techtrials Pesquisa e Tecnologia Ltda;PharmagenixWithdrawn18 Years80 YearsAll0Phase 2NULL
92NCT04312815December 28, 201716/3/2020A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTXA Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving MethotrexateRheumatoid Arthritis(RA)Drug: SM03;Drug: Placebo;Drug: MTXSinoMab Pty LtdNULLRecruiting18 Years70 YearsAll510Phase 3China
93EUCTR2017-000384-32-BG02/11/201712/07/2017Phase IIb in Rheumatoid ArthritisA Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
363Phase 2United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan
94NCT03440892November 1, 201714/2/2018Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis PatientsLongitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of SurvivinRheumatoid ArthritisDrug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinibVastra Gotaland RegionNULLRecruiting20 YearsN/AAll2500Sweden
95NCT02647762October 30, 201716/12/2015CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid ArthritisA Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid ArthritisRheumatoid ArthritisDrug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTXCan-Fite BioPharmaNULLActive, not recruiting18 Years75 YearsAll525Phase 3Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2016-004834-11-GB23/10/201716/08/2017A 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: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
97NCT03163966October 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
98NCT03254589October 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
99NCT03257852September 29, 201720/8/2017A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on MethotrexateA Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis (RA)Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapyAstellas Pharma IncNULLCompleted20 YearsN/AAll66Phase 2Japan
100EUCTR2017-000384-32-CZ26/09/201726/07/2017Phase IIb in Rheumatoid ArthritisA Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A 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]
Merck KGaANULLNot Recruiting Female: yes
Male: yes
363 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT03233230September 18, 201725/7/2017Phase IIb Study of Evobrutinib in Subjects With Rheumatoid ArthritisA Phase IIb, Randomized, Double-blind Study in Subjects With Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared With Placebo in Subjects With an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: M2591 25 mg QD;Drug: M2951 75 mg QD;Drug: M2951 50 mg BID;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted18 Years75 YearsAll390Phase 2United States;Argentina;Bulgaria;Chile;Colombia;Czechia;Mexico;Poland;Russian Federation;Serbia;South Africa;Ukraine;Brazil;Germany;Hungary;Romania;Slovakia;Spain
102EUCTR2016-004834-11-PL05/09/201717/07/2017A 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
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
103EUCTR2016-004834-11-BG04/09/201701/06/2017A 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
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
104NCT04177173September 1, 20177/4/2019Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid ArthritisComparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.Arthritis, RheumatoidDrug: Simvastatin 20 mg;Drug: Methotrexate 10 mgKing Edward Medical UniversityNULLCompleted18 YearsN/AAll100Phase 4Pakistan
105EUCTR2016-004834-11-CZ16/08/201702/08/2017A 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
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
106NCT03155347August 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
107EUCTR2016-000568-41-NL18/07/201729/06/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
108EUCTR2016-004834-11-DK06/07/201711/05/2017A 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
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
109NCT03120949July 4, 20177/2/2017Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Olokizumab 64 mg SC q4w;Drug: Olokizumab 64 mg SC q2w;Drug: MethotrexateR-PharmQuintiles, Inc.;OCT Clinical Trials;Mene ResearchRecruiting18 YearsN/AAll1880Phase 3United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom
110EUCTR2016-001825-15-IT28/06/201716/02/2018A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinb
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
PFIZER INCNULLNot RecruitingFemale: yes
Male: yes
580Phase 3Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2016-001825-15-DE26/06/201701/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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]
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
580 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
112EUCTR2015-002887-17-FR19/06/201716/02/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
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]
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
610 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
113JPRN-UMIN0000277192017/06/1212/06/2017Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. rheumatoid arthritis/remissionadd-on iguratimod
tapering MTX
continuing the treatment
Osaka Medical CollegeNULLRecruiting20years-old100years-oldMale and Female100Not selectedJapan
114EUCTR2016-002337-30-HR05/06/201712/09/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
115NCT03139136May 30, 201726/4/2017Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid ArthritisA 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving MethotrexateRheumatoid ArthritisDrug: MBS2320;Drug: PlaceboModern Biosciences plcNULLCompleted18 Years75 YearsAll121Phase 2Georgia;Moldova, Republic of;Romania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2016-002337-30-DE24/05/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
269 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
117JPRN-UMIN0000272502017/05/1508/05/2017Precision medicine of methotrexate in the patients with rheumatoid arthritis Rheumatoid arthritisMTX administrationKeio UniversityFukuoka Tokushukai HospitalNULLComplete: follow-up complete20years-old90years-oldMale and Female50Not selectedJapan
118NCT03131973May 13, 201725/4/2017Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and PravastatinEffects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy ParticipantsRheumatoid ArthritisDrug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: PravastatinBristol-Myers SquibbNULLCompleted18 Years50 YearsAll26Phase 1United States
119EUCTR2016-000897-39-DE10/05/201727/10/2016An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
120EUCTR2016-001825-15-BE08/05/201728/02/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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]
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;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
121EUCTR2016-002337-30-CZ03/05/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
122EUCTR2016-001825-15-HU01/05/201722/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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]
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
580 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
123EUCTR2016-000568-41-DE19/04/201724/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
124EUCTR2016-000570-37-DE19/04/201724/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
125EUCTR2016-002337-30-BG11/04/201730/01/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2016-001825-15-BG11/04/201707/02/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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]
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
127EUCTR2016-002337-30-SK10/04/201708/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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]
Pfizer Inc.,NULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
128EUCTR2016-001825-15-GB03/04/201701/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
680Phase 3;Phase 4Korea, Republic of;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany
129EUCTR2016-000897-39-BE03/04/201702/02/2017An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. Rheumatoid Arthritis
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
130NCT03275025April 1, 201728/8/2017A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)Rheumatoid ArthritisDrug: YRA-1909 low dose;Drug: YRA-1909 mid dose;Drug: YRA-1909 high dose;Drug: PlaceboYungjin Pharm. Co., Ltd.NULLRecruiting19 Years80 YearsAll200Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2016-001825-15-PL29/03/201708/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
680Phase 3;Phase 4Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of
132EUCTR2016-002862-30-PL28/03/201703/04/2017A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
133EUCTR2016-002337-30-ES27/03/201710/03/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
134EUCTR2011-004720-35-NL22/03/201722/02/2017A 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 treatment.A 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 treatment. - NORD-STAR Rheumatoid arthritis (RA)
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
INN or Proposed INN: PREDNISOLONE
The Karolinska Institute, ClinTRIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Iceland;Netherlands;Sweden
135EUCTR2016-002862-30-CZ22/03/201714/12/2016A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2016-001825-15-CZ21/03/201721/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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]
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
137EUCTR2016-000570-37-BG21/03/201713/02/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
138EUCTR2016-000568-41-BG21/03/201724/01/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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
1650 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
139EUCTR2016-002337-30-HU16/03/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
140EUCTR2016-002862-30-DE15/03/201726/01/2017A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2016-001825-15-ES09/03/201710/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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] - Immune System Diseases [C20]
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
580 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
142EUCTR2015-005307-83-LV03/03/201716/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 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]
R-PharmNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
143NCT03161457February 27, 201721/4/2017A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) TherapyRheumatoid Arthritis;Arthritis, RheumatoidBiological: JHL1101;Biological: MabTheraJHL Biotech, Inc.NULLTerminated18 Years80 YearsAll153Phase 1Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom
144EUCTR2014-004868-38-DE23/02/201725/05/2016A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
145EUCTR2016-002862-30-BG16/02/201710/01/2017A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2016-001825-15-SK16/02/201714/12/2016A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION Rheumatoid Arthritis
MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
147EUCTR2016-002862-30-SK16/02/201714/12/2016A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
148EUCTR2016-000568-41-PL15/02/201714/02/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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
1650 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
149EUCTR2016-000570-37-PL15/02/201713/02/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
150EUCTR2016-002862-30-HU31/01/201723/11/2016A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 19.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2016-000570-37-BE30/01/201717/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy 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
1200 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
152NCT03028467January 24, 201710/1/2017Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid ArthritisA Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With MethotrexateArthritis, RheumatoidDrug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acidGlaxoSmithKlineNULLCompleted20 YearsN/AAll15Phase 1/Phase 2Japan
153EUCTR2016-000570-37-ES13/01/201713/01/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy 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]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
154EUCTR2016-000568-41-ES13/01/201713/01/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
155EUCTR2016-000897-39-HU09/01/201719/10/2016An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2016-000568-41-CZ05/01/201721/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
157EUCTR2016-000570-37-CZ05/01/201722/11/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy 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
1200 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
158EUCTR2016-000568-41-BE04/01/201717/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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
1650 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
159EUCTR2016-000568-41-GB23/12/201613/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
160NCT03001219December 22, 201620/12/2016A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha TherapyA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha InhibitorsRheumatoid ArthritisDrug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520Hoffmann-La RocheNULLTerminated18 YearsN/AAll109Phase 2United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2016-001496-75-CZ20/12/201630/09/2016A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
162NCT02969044December 20, 201617/11/2016Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To MethotrexateA Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: PF-06651600PfizerNULLCompleted18 Years75 YearsAll70Phase 2United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia
163NCT02862574December 15, 20168/8/2016Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid ArthritisEvaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF InhibitorGilead SciencesNULLTerminated18 Years80 YearsAll15Phase 2United States;Australia;Hungary;Taiwan
164EUCTR2016-001496-75-PL13/12/201603/11/2016A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
165EUCTR2016-000570-37-HU02/12/201619/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2016-000568-41-HU02/12/201619/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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
1650 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
167NCT03016260December 20164/1/2017RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid ArthritisProof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination.RheumatoId ArthritisBiological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilarTcLand Expression S.A.European CommissionTerminated18 YearsN/AAll250Czechia;France;Israel;Netherlands;Turkey;Czech Republic
168EUCTR2016-000570-37-SK29/11/201604/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy 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
1200 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
169NCT02874092November 15, 201617/8/2016Ticagrelor in Methotrexate-Resistant Rheumatoid ArthritisTicagrelor in Methotrexate-Resistant Rheumatoid ArthritisRheumatoid ArthritisDrug: Ticagrelor;Drug: MTX therapyNYU Langone HealthNULLCompleted18 YearsN/AAll9Phase 4United States
170EUCTR2016-000570-37-GB14/11/201617/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT02996500November 10, 201613/10/2016Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To MethotrexateA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATERheumatoid ArthritisDrug: PF-06650833;Drug: Placebo;Drug: TofacitinibPfizerNULLCompleted18 Years75 YearsAll269Phase 2United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine
172EUCTR2015-005307-83-DE10/11/201624/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 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]
R-PharmNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
173EUCTR2015-003334-27-FI02/11/201617/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
975Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;New Zealand;Japan
174NCT02960438November 2, 20163/11/2016A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to MethotrexateA Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to MethotrexateRheumatoid ArthritisDrug: E6011;Drug: PlaceboEisai Co., Ltd.NULLCompleted18 Years75 YearsAll190Phase 2Japan
175JPRN-jRCTs04118007113/10/201607/03/2019T-ReX studyTocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study Rheumatoid arthritisAt week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.Kojima ToshihisaNULLComplete>= 20age oldNot applicableBoth51N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2016-000568-41-SK11/10/201604/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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
1650 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
177NCT03403140October 6, 201630/11/2017Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: EtanerceptGema Biotech S.A.QUID Quality in Drugs and Devices Latin American Consulting SRLUnknown status19 Years99 YearsAll141Phase 3Argentina
178JPRN-UMIN0000240252016/10/0101/10/2016The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA studyThe clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study - ALIBABA study Rheumatoid Arthritisreceiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week)
receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week)
Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and WelfareNULLRecruiting20years-oldNot applicableMale and Female80Not appl1cableJapan
179NCT02037737September 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
180NCT02885181September 21, 201626/8/2016Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With MethotrexateA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With MethotrexateRheumatoid ArthritisDrug: GS-9876;Drug: Filgotinib;Drug: GS-9876 placebo;Drug: Filgotinib placebo;Drug: MethotrexateGilead SciencesNULLCompleted18 Years75 YearsAll83Phase 2United States;Bulgaria;Czechia;Georgia;Moldova, Republic of;Poland;Ukraine;Czech Republic;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT02884635September 16, 201626/8/2016A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking MethotrexatePhase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)Rheumatoid ArthritisDrug: ASP1707;Drug: Placebo;Drug: MethotrexateAstellas Pharma IncNULLCompletedN/AN/AFemale72Phase 2Japan
182NCT02833350September 9, 201612/7/2016Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2)Rheumatoid ArthritisDrug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: PlaceboGenentech, Inc.NULLCompleted18 Years75 YearsAll578Phase 2United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile
183EUCTR2015-003334-27-SI07/09/201614/12/2015A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
184NCT02831855September 1, 201611/7/2016Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid ArthritisA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATIONRheumatoid ArthritisDrug: CP-690,550;Drug: Methotrexate;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll694Phase 4United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom
185NCT02897011September 20167/9/20162-week dc of MTX and Influenza Vaccination in RAEffect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical TrialRheumatoid Arthritis;Influenza;MethotrexateDrug: MethotrexateSeoul National University HospitalNULLRecruiting18 Years65 YearsBoth318N/AKorea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT02930343September 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
187NCT02889796August 30, 201631/8/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinib;Drug: Adalimumab;Drug: Placebo to match adalimumab;Drug: MTXGilead SciencesGalapagos NVCompleted18 YearsN/AAll1759Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic;France
188EUCTR2015-003334-27-LT30/08/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
189EUCTR2016-000335-40-BG23/08/201608/07/2016A Study examining the treatment effect and Safety of GDC-0853 when compared With Placebo and a biologic therapy (Adalimumab) in Rheumatoid Arthritis Patients who have not responded or intolerance to Previous therapies. A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB IN PATIENTS WITH AN INADEQUATE RESPONSE TO PREVIOUS METHOTREXATE THERAPY (COHORT 1) AND COMPARED WITH PLACEBO IN PATIENTS WITH AN INADEQUATE RESPONSE OR INTOLERANCE TO PREVIOUS TNF THERAPY (COHORT 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] - Immune System Diseases [C20]
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
190EUCTR2015-004386-91-DE22/08/201618/05/2016Study 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
40 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited 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
191EUCTR2015-003334-27-BG18/08/201618/07/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
192EUCTR2016-000064-42-BG11/08/201628/06/2016 Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A 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]
Merck KGaANULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria
193EUCTR2015-003333-95-FI10/08/201619/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
194NCT02886728August 8, 201629/8/2016Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX TherapyA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX TherapyRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTXGilead SciencesGalapagos NVCompleted18 YearsN/AAll1252Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
195EUCTR2016-000064-42-HU05/08/201606/06/2016Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 2Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;Bulgaria;South Africa
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2015-005307-83-BG04/08/201617/06/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely Active 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]
R-Pharm International LLCNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
197EUCTR2015-003376-75-BG02/08/201618/07/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
198NCT02940561August 201615/9/2016BE Study in Patients - Methotrexate TabletsA Multicenter, Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single-dose, Two-way, Crossover, Bioequivalence Study of Methotrexate Tablets USP, 2.5 mg Manufactured by Amneal Pharmaceuticals, With Methotrexate Tablets USP 2.5 mg Manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in Patients With Mild to Severe Psoriasis or Rheumatoid Arthritis, Who Are Already on Established Regimens of 2.5 mg Every 12 Hours Under Fasting Condition.Psoriasis;Rheumatoid ArthritisDrug: Methotrexate - Amneal;Drug: Methotrexate - DAVAAmneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Recruiting18 Years65 YearsBoth48Phase 1India
199NCT02722694August 201610/3/2016A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateA Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept 125mg Administered Subcutaneously in Chinese Subjects With Active Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to MethotrexateRheumatoid Arthritis (RA)Drug: Subcutaneous(SC) Abatacept;Other: Placebo;Drug: MethotrexateJiangsu Simcere Pharmaceutical Co., Ltd.Bristol-Myers SquibbRecruiting18 YearsN/ABoth360Phase 3China
200NCT02784106July 31, 201624/5/2016Safety and Efficacy Study of M2951 in Participants With Rheumatoid ArthritisPhase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate TherapyRheumatoid ArthritisDrug: Placebo;Drug: M2951EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted18 Years75 YearsAll65Phase 2United States;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2015-003376-75-GR28/07/201613/05/2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Japan;New Zealand;Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary
202JPRN-JapicCTI-16331728/7/201613/07/2016Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors Rheumatoid ArthritisIntervention name : BMS-986142
INN of the intervention : -
Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified
Bristol-Myers Squibb K.K.NULLcomplete18120BOTH408Phase 2Japan, Asia except Japan, North America, South America, Europe, Oceania
203EUCTR2015-003334-27-CZ27/07/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
204EUCTR2016-000064-42-SK27/07/201603/05/2016Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 2Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
205EUCTR2015-003376-75-CZ27/07/201603/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT02867306July 25, 201611/8/2016A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid ArthritisA Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ASP1707;Drug: methotrexate (MTX)Astellas Pharma Global Development, Inc.NULLCompleted18 Years65 YearsAll10Phase 1Moldova, Republic of
207JPRN-UMIN0000212472016/07/2222/07/2016Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-stateTocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study) Rheumatoid arthritisDouble the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained.Nagoya University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female51Not selectedJapan
208EUCTR2015-003333-95-LT21/07/201609/05/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
209ChiCTR-IPR-160087932016-07-152016-06-10A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritisA multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis Rheumatoid arthritisexperimental group:ZHENGQING FENGTONGNING sustained release tablets; control group:methotrexate;The combined treatment group:ZHENGQING FENGTONGNING sustained release tablets combine methotrexate;The First Affiliated Hospital of Third Military Medical UniversityNULLRecruiting1875Bothexperimental group:80; control group:80;The combined treatment group:80;China
210EUCTR2015-003334-27-HU13/07/201610/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2015-003333-95-BG13/07/201625/03/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
212EUCTR2015-003334-27-ES08/07/201619/01/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 15 mg Once Daily Monotherapy and ABT-494 30 mg Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Egypt;Hungary;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;New Zealand;Japan
213EUCTR2015-005307-83-PL06/07/201601/06/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira)
Product Code: LO4AB04
R-PharmNULLNot RecruitingFemale: yes
Male: yes
1575Phase 3United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
214EUCTR2015-003376-75-HU06/07/201609/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
215EUCTR2015-003376-75-PL28/06/201608/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2015-003334-27-PL28/06/201608/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
217EUCTR2015-003376-75-ES23/06/201619/01/2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand
218EUCTR2015-003334-27-GR22/06/201613/05/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;New Zealand;Japan
219EUCTR2016-000064-42-CZ21/06/201608/06/2016Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 2Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
220EUCTR2015-003334-27-IE17/06/201607/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2015-003376-75-PT17/06/201609/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
222EUCTR2015-003334-27-PT17/06/201609/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3United States;Belarus;Portugal;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
223EUCTR2015-003334-27-LV17/06/201608/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Kazakhstan;New Zealand;Japan;United States
224EUCTR2015-003334-27-GB15/06/201609/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
225NCT02799472June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2015-003376-75-AT10/06/201628/06/2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
227EUCTR2015-005308-27-HU09/06/201628/04/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 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]
R-PharmNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of
228EUCTR2015-005307-83-HU09/06/201628/04/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
R-PharmNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1575Phase 3United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
229EUCTR2015-001275-50-NL08/06/201610/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
230EUCTR2015-003334-27-HR08/06/201606/07/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2015-005307-83-CZ07/06/201618/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 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]
R-Pharm International LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
232EUCTR2015-003334-27-BE07/06/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia
233EUCTR2015-002887-17-BE07/06/201616/02/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
234EUCTR2015-003376-75-BE07/06/201606/06/2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
235NCT02760407May 24, 201629/4/2016Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active DiseaseA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyRheumatoid ArthritisDrug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2wR-PharmQuintiles, Inc.;OCT Clinical TrialsActive, not recruiting18 YearsN/AAll1575Phase 3United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2015-003333-95-HU18/05/201607/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
237EUCTR2014-004719-36-BG14/05/201605/04/2016Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1 Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Olokizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLNot RecruitingFemale: yes
Male: yes
420Phase 3Belarus;Turkey;Russian Federation;Bulgaria
238EUCTR2015-003333-95-GR12/05/201610/05/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
239EUCTR2015-003333-95-CZ11/05/201622/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
240EUCTR2015-003333-95-ES06/05/201619/01/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;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
241EUCTR2015-003333-95-PT06/05/201608/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Serbia;Belarus;United States;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
242EUCTR2015-005307-83-LT04/05/201625/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely Active 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]
R-PharmNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
243NCT02760368May 201629/4/2016Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active DiseaseA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyRheumatoid ArthritisDrug: Olokizumab;Drug: PlaceboR-Pharm International, LLCQuintiles, Inc.;OCT Clinical Trials;Mene ResearchCompleted18 YearsN/AAll428Phase 3Belarus;Bulgaria;Russian Federation;Turkey
244EUCTR2015-003333-95-DE25/04/201614/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
245EUCTR2015-003333-95-IE22/04/201608/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;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
246EUCTR2015-003333-95-LV20/04/201612/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;Germany;New Zealand
247EUCTR2015-003333-95-AT20/04/201612/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
248EUCTR2015-002887-17-NL20/04/201622/02/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
249EUCTR2014-004868-38-IT16/04/201606/11/2020A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. - A study comparing the use of etanercept and methotrexate, used either alone or in combination, for m Rheumatoid arthritis
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL
Product Name: Enbrel
Product Code: [NA]
INN or Proposed INN: ETANERCEPT
Trade Name: METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP
Product Name: methotrexate
Product Code: [NA]
INN or Proposed INN: METOTREXATO
AMGEN INC.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;Hungary;Czech Republic;Greece;Spain;Bulgaria;Germany;United Kingdom;Italy
250EUCTR2015-003333-95-DK15/04/201607/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;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
251EUCTR2015-003333-95-GB14/04/201611/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
252EUCTR2015-003333-95-BE13/04/201607/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
253EUCTR2015-003333-95-HR05/04/201628/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
254NCT02715908April 201617/3/2016A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002Rheumatoid ArthritisDrug: LBEC0101LG Life SciencesNULLCompleted20 Years75 YearsAll148Phase 3Korea, Republic of
255NCT02746380April 20165/4/2016A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyMulti-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTXArthritis, RheumatoidDrug: LBAL;Drug: Humira®LG Life SciencesMochida Pharmaceutical Company, Ltd.Active, not recruiting20 Years75 YearsAll380Phase 3Japan;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
256EUCTR2015-002887-17-AT29/03/201618/01/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986142
Product Code: BMS-986142
INN or Proposed INN: BMS986142
Product Name: BMS-986142
Product Code: BMS-986142
INN or Proposed INN: BMS986142
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
257EUCTR2015-002887-17-ES28/03/201613/01/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
258NCT02706951March 23, 201618/2/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTXRheumatoid ArthritisDrug: Methotrexate;Drug: Upadacitinib;Drug: Placebo Upadacitinib;Drug: Placebo MethotrexateAbbVieNULLActive, not recruiting18 Years99 YearsAll648Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Czechia;Estonia;Greece;Hungary;Israel;Italy;Japan;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;Colombia;Czech Republic;New Zealand
259EUCTR2014-004868-38-PT07/03/201618/12/2015A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;United States;Portugal;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
260JPRN-UMIN0000211572016/03/0129/02/2016Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate Rheumatoid arthritisadministration of weekly MTX dose at once.
administration by dividing three times of weekly MTX dose.
Yokohama Minami Kyousai HospitalAYUMI Pharmaceutical corporationComplete: follow-up completeNot applicableNot applicableMale and Female120Not appl1cableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT02714634March 20161/2/2016Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to MethotrexateRandomized Controlled Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to MethotrexateRheumatoid Arthritis;Insufficient Response to Methotrexate.Drug: Methotrexate + biologic administration;Drug: methotrexate + salazopyrine + hydroxychloroquine administrationUniversity Hospital, Strasbourg, FranceNULLNot yet recruiting18 YearsN/ABoth286Phase 4NULL
262NCT02698657February 23, 201610/2/2016A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on MethotrexateA Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis (RA)Drug: ASP5094;Drug: PlaceboAstellas Pharma Global Development, Inc.NULLCompleted18 Years65 YearsAll30Phase 1United States;Poland
263NCT02706873February 23, 201618/2/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken MethotrexateA Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Upadacitinib Placebo;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: UpadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll1002Phase 3United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Kazakhstan;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Malaysia;Netherlands
264NCT02638948February 16, 201621/12/2015Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF InhibitorsRheumatoid ArthritisDrug: BMS-986142;Drug: Placebo;Drug: MethotrexateBristol-Myers SquibbNULLCompleted18 Years120 YearsAll508Phase 2United States;Argentina;Austria;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Belgium
265EUCTR2015-001275-50-RO10/02/201622/02/2016Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266EUCTR2014-004868-38-HU09/02/201611/12/2015A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;United States;Czech Republic;Hungary;Greece;Canada;Argentina;Spain;Bulgaria;Germany
267EUCTR2015-001275-50-HU09/02/201604/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
268EUCTR2014-004868-38-BG02/02/201622/12/2015A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
269NCT03332719February 201621/4/2016Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid ArthritisMulticentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: Etanercept;Drug: MethotrexateGema Biotech S.A.QUID-Quality in Drugs and Devices Latin American Consulting SRLCompleted19 Years99 YearsAll168Phase 3Argentina
270NCT02683564February 20169/2/2016BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM StudyA Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM StudyRheumatoid ArthritisDrug: BOW015;Drug: RemicadeEpirus Biopharmaceuticals (Switzerland) GmbHNULLNot yet recruiting18 Years80 YearsBoth548Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2014-004868-38-GR26/01/201602/12/2015A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
720Phase 3France;Portugal;United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria;Germany
272EUCTR2014-004868-38-ES19/01/201613/01/2016A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
720 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
273EUCTR2014-000358-13-DE14/01/201631/07/2015A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Zostavax®
Product Name: Zostavax
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
274EUCTR2014-004868-38-FR12/01/201618/01/2016A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
720 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;France;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
275NCT02762838January 20164/4/2016Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisInternational Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acidBiocadNULLCompleted18 Years75 YearsAll426Phase 3Belarus;India;Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT02878161January 201612/7/2016Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real WorldScreening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal PathwayRheumatoid ArthritisDrug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)Fen LiNULLEnrolling by invitation18 Years75 YearsBoth240Phase 4NULL
277NCT02608112December 31, 201516/11/2015Study to Describe Real World Drug Retention Rate of the Tocilizumab at One YearSubcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 YearRheumatoid ArthritisDrug: Methotrexate;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll291France
278NCT02644499December 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
279EUCTR2014-000352-29-HR29/12/201501/02/2016A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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]
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
280EUCTR2014-004868-38-CZ21/12/201503/12/2015A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
358 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;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
281EUCTR2015-001275-50-AT20/12/201523/11/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
282EUCTR2015-003333-95-SK18/12/201504/11/2015A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
283EUCTR2015-001275-50-IT17/12/201505/11/2020Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis.A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive - ND Early Rheumatoid Arthritis
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: [BMS-188667]
INN or Proposed INN: ABATACEPT
Other descriptive name: ND
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Product Code: [na]
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Product Code: [na]
INN or Proposed INN: METOTREXATO
Other descriptive name: METHOTREXATE
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
284EUCTR2015-001275-50-ES15/12/201510/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
285EUCTR2015-003334-27-SK11/12/201504/11/2015A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2015-001275-50-SE09/12/201504/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
287EUCTR2015-001275-50-FI08/12/201508/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive - Early Rheumatoid Arthritis
MedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
288EUCTR2015-001275-50-GB04/12/201526/11/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
289EUCTR2015-001275-50-DE01/12/201524/11/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: