Adalimumab    (DrugBank: Adalimumab)

16 diseases
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病2
37膿疱性乾癬(汎発型)1
40高安動脈炎1
41巨細胞性動脈炎1
46悪性関節リウマチ455
56ベーチェット病4
84サルコイドーシス5
96クローン病208
97潰瘍性大腸炎151
151ラスムッセン脳炎1
160先天性魚鱗癬1
164眼皮膚白皮症1
222一次性ネフローゼ症候群3
226間質性膀胱炎(ハンナ型)1
269化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群3
271強直性脊椎炎68

19. ライソゾーム病 [臨床試験数:784,薬物数:673(DrugBank:101),標的遺伝子数:68,標的パスウェイ数:184
Searched query = "Lysosomal storage disease", "Lysosomal disease", "Gaucher disease", "Niemann-Pick disease", "Niemann-Pick type C", "GM1-gangliosidosis", "GM1-gangliosidoses", "GM2-gangliosidosis", "GM2-gangliosidoses", "Tay-Sachs disease", "Sandhoff disease", "Krabbe disease", "Metachromatic leukodystrophy", "Multiple-sulfatase deficiency", "Farber disease", "Mucopolysaccharidosis type I", "Mucopolysaccharidosis I", "MPS I", "Hurler syndrome", "Scheie syndrome", "Mucopolysaccharidosis type II", "Mucopolysaccharidosis II", "MPS II", "Hunter syndrome", "Mucopolysaccharidosis type III", "Mucopolysaccharidosis III", "MPS III", "Sanfilippo syndrome", "Mucopolysaccharidosis type IV", "Mucopolysaccharidosis IV", "MPS IV", "MPS IVA", "Morquio syndrome", "Morquio A syndrome", "Mucopolysaccharidosis type VI", "Mucopolysaccharidosis VI", "MPS VI", "Maroteaux-Lamy syndrome", "Mucopolysaccharidosis type VII", "Mucopolysaccharidosis VII", "MPS VII", "Sly syndrome", "Mucopolysaccharidosis type IX", "Mucopolysaccharidosis IX", "MPS IX", "Hyaluronidase deficiency", "Sialidosis", "Galactosialidosis", "Mucolipidosis II", "Mucolipidosis type II", "I-cell disease", "Mucolipidosis III", "Mucolipidosis type III", "Alpha-Mannosidosis", "Alpha-Mannosidase Deficiency", "Beta-Mannosidosis", "Beta-Mannosidase Deficiency", "Fucosidosis", "Aspartylglucosaminuria", "Schindler disease", "Kanzaki disease", "Pompe disease", "Acid lipase deficiency", "Wolman disease", "Cholesterol ester storage disease", "Danon disease", "Free sialic acid storage disease", "Salla disease", "Ceroid lipofuscinosis", "Fabry disease", "Cystinosis"
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.
2 / 784 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
1NCT03153319
(ClinicalTrials.gov)
June 5, 201711/5/2017Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I and IIPhase 1/2 Study of the Effect of Adalimumab on Physical Function and Musculoskeletal Disease in Mucopolysaccharidosis Types I and IIMucopolysaccharidosis I;Mucopolysaccharidosis IIDrug: Adalimumab Injection [Humira];Drug: Saline Solution for InjectionLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterNULLRecruiting5 YearsN/AAll14Phase 1/Phase 2United States
2NCT02437253
(ClinicalTrials.gov)
May 20155/5/2015Effects of Adalimumab in Mucopolysaccharidosis Types I, II and VIPilot Study of the Effect of Adalimumab on Physical Function and Musculoskeletal Disease in Mucopolysaccharidosis Types I, II and VIMucopolysaccharidosis Type I;Mucopolysaccharidosis Type II;Mucopolysaccharidosis Type VIDrug: Adalimumab;Other: PlaceboLos Angeles Biomedical Research InstituteNULLCompleted5 YearsN/AAll2Phase 1/Phase 2United States

37. 膿疱性乾癬(汎発型) [臨床試験数:58,薬物数:50(DrugBank:18),標的遺伝子数:17,標的パスウェイ数:96
Searched query = "Generalised pustular psoriasis", "Pustular psoriasis", "Herpetic impetigo", "Generalization of acrodermatitis continua", "Generalization of dermatitis continua of the extremities"
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.
1 / 58 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02533375
(ClinicalTrials.gov)
September 28, 201520/8/2015Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular PsoriasisGeneralized Pustular Psoriasis (GPP);Adalimumab;JapaneseDrug: AdalimumabAbbVieNULLCompleted15 Years75 YearsAll10Phase 3Japan

40. 高安動脈炎 [臨床試験数:22,薬物数:46(DrugBank:20),標的遺伝子数:22,標的パスウェイ数:111
Searched query = "Takayasu arteritis", "Aortitis syndrome", "Pulseless disease"
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.
1 / 22 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04300686
(ClinicalTrials.gov)
March 1, 20205/3/2020A Pilot Study in Severe Patients With Takayasu Arteritis.A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA CohortTakayasu Arteritis;Tocilizumab;Adalimumab;TreatmentBiological: Tocilizumab;Biological: AdalimumabShanghai Zhongshan HospitalNULLRecruiting14 Years100 YearsAll40Phase 4China

41. 巨細胞性動脈炎 [臨床試験数:108,薬物数:111(DrugBank:32),標的遺伝子数:33,標的パスウェイ数:121
Searched query = "Giant cell arteritis", "Temporal arteritis"
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.
1 / 108 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00305539
(ClinicalTrials.gov)
May 200621/3/2006HECTHOR: Humira to Spare Steroids in Giant Cell ArteritisHECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell ArteritisGiant Cell ArteritisDrug: adalimumab;Drug: placeboAssistance Publique - Hôpitaux de ParisAbbottCompleted50 YearsN/ABoth69Phase 3France

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.
455 / 4,183 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04255134
(ClinicalTrials.gov)
September 7, 202014/11/2019Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV TrialRheumatoid ArthritisDrug: Abatacept Injection;Drug: Adalimumab InjectionSt George's, University of LondonNULLRecruiting18 Years75 YearsAll60Phase 4United Kingdom
2NCT04115423
(ClinicalTrials.gov)
April 1, 20202/10/2019A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving TocilizumabA Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance DatabaseInfection;Rheumatoid ArthritisDrug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)Sungkyunkwan UniversityMinistry of Food and Drug Safety, KoreaActive, not recruiting18 YearsN/AAll9508Korea, Republic of
3EUCTR2019-003700-12-FR
(EUCTR)
13/03/202004/06/2020Association 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: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System 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
4NCT04222920
(ClinicalTrials.gov)
March 1, 20207/1/2020Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease ActivityAdalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity: a Single Blind, Non-inferiority, Randomised Clinical TrialRheumatoid ArthritisOther: Dose reduction to 2mg/L;Other: Dose reduction to 5mg/L;Drug: AdalimumabReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and Development;Sint MaartenskliniekRecruiting18 YearsN/AAll89Phase 4Netherlands
5NCT04251741
(ClinicalTrials.gov)
March 1, 20208/1/2020Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab TreatmentUsing Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment: a Blinded Randomized Superiority TrialRheumatoid ArthritisDiagnostic Test: Adalimumab trough concentration;Other: Usual careReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and Development;Sint MaartenskliniekRecruiting18 YearsN/AAll84Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04194827
(ClinicalTrials.gov)
March 1, 20203/12/2019Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug MonitoringAdalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring (ADDORA): Multi-centre Open Label Randomised Controlled TrailRheumatoid ArthritisDiagnostic Test: Adalimumab serum trough concentration;Diagnostic Test: Disease activity;Drug: AdalimumabReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and Development;Sint MaartenskliniekRecruiting18 YearsN/AAll267Phase 4Netherlands
7EUCTR2019-000284-24-CZ
(EUCTR)
03/02/202017/10/2019A 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System 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
8NCT04230213
(ClinicalTrials.gov)
January 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
9EUCTR2019-000284-24-LT
(EUCTR)
18/12/201907/11/2019A 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System 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
10EUCTR2018-003351-37-LT
(EUCTR)
13/12/201929/08/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE 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]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-001754-25-NL
(EUCTR)
25/11/201925/11/2019Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatmentUsing adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch) rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Enbrel, Benepali, Erelzi
Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: RITUXIMAB
INN or Proposed INN: ABATACEPT
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
INN or Proposed INN: SARILUMAB
ReadeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 4Netherlands
12EUCTR2019-001793-28-NL
(EUCTR)
05/11/201905/11/2019Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW)Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial - ADDORA-Low Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]ReadeNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
89 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
13EUCTR2019-001554-25-NL
(EUCTR)
29/10/201929/10/2019 Adalimumab dose optimization in rheumatoid arthritis using drug concentration in blood (ADDORA): multi-center open label randomized controlled trail Adalimumab dose optimization in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-center open label randomized controlled trail - ADalimumab Dose Optimization in Rheumatoid Arthritis using (ADDORA) Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]ReadeNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
267 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
14EUCTR2018-003351-37-GR
(EUCTR)
13/09/201929/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE 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]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
15NCT04171414
(ClinicalTrials.gov)
September 9, 201918/9/2019A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid ArthritisA Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisBiological: CT-P17 SC AI (adalimumab)CelltrionPPDRecruiting18 Years70 YearsAll50Phase 3Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-003351-37-DK
(EUCTR)
29/08/201907/08/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE 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]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;South Africa;Germany;Netherlands
17EUCTR2018-003351-37-NL
(EUCTR)
29/08/201908/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE 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]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
18EUCTR2018-003351-37-GB
(EUCTR)
08/08/201916/05/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE 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]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
19EUCTR2018-003351-37-DE
(EUCTR)
02/08/201924/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE 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]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4South Africa;Germany;Netherlands;United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Australia;Denmark
20NCT04018599
(ClinicalTrials.gov)
July 15, 201911/7/2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesCompleted18 Years55 YearsAll216Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03619876
(ClinicalTrials.gov)
July 10, 20193/8/2018Effects of Abatacept on Myocarditis in Rheumatoid ArthritisEffects of Abatacept on Myocarditis in Rheumatoid ArthritisRheumatoid Arthritis;Myocardial InflammationDrug: Abatacept;Drug: AdalimumabColumbia UniversityBristol-Myers SquibbRecruiting18 YearsN/AAll20Phase 4United States
22EUCTR2019-000660-25-PL
(EUCTR)
09/07/201920/05/2019Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid ArthritisA Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe 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]
Product Name: CT-P17
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
CELLTRION, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Poland
23EUCTR2018-003053-21-PL
(EUCTR)
27/06/201916/04/2019A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid ArthritisRandomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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]
Product Code: ABBV-3373
INN or Proposed INN: ABBV-3373
Trade Name: Humira (adalimumab)
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Puerto Rico;Poland;Israel
24NCT03823391
(ClinicalTrials.gov)
March 27, 201929/1/2019A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid ArthritisRheumatoid Arthritis (RA)Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumabAbbVieNULLCompleted18 Years75 YearsAll48Phase 2United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico
25NCT03737708
(ClinicalTrials.gov)
February 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_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-001690-25-LT
(EUCTR)
08/02/201929/08/2018Evaluating 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: 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
27EUCTR2018-001690-25-PL
(EUCTR)
11/12/201825/09/2018Evaluating 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: 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
28EUCTR2018-001690-25-HU
(EUCTR)
13/11/201814/08/2018Evaluating 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: 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
29EUCTR2018-001690-25-BG
(EUCTR)
05/11/201819/09/2018Evaluating 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: 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
30NCT03505008
(ClinicalTrials.gov)
April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31JPRN-jRCT1031180088
18/04/201818/01/2019MIRACLE 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 applicableBoth300Phase 4South Korea;Taiwan;Japan
32JPRN-UMIN000030584
2018/04/1827/12/2017MIRACLE (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)
33NCT03100253
(ClinicalTrials.gov)
March 1, 201817/3/2017Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGationOpen-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNFRheumatoid ArthritisDrug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab PegolMario Negri Institute for Pharmacological ResearchNULLRecruiting18 YearsN/AAll208Phase 4Italy
34EUCTR2016-000568-41-NL
(EUCTR)
18/07/201729/06/2017Filgotinib 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
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
35JPRN-jRCT2071200057
08/07/201725/11/2020Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter studyA Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study Rheumatoid arthritis;D001172Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug
Yazawa RieNULLComplete>= 20age old< 45age oldMale130Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-000568-41-DE
(EUCTR)
19/04/201724/10/2016Filgotinib 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
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
37NCT03110094
(ClinicalTrials.gov)
March 13, 201710/3/2017Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid ArthritisInvestigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T SubpopulationsRheumatoid ArthritisOther: Adalimumab;Other: Healthy volunteersRennes University HospitalNULLUnknown status18 YearsN/AAll60N/AFrance
38EUCTR2016-002852-26-DE
(EUCTR)
09/03/201706/10/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
260Phase 3Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
39EUCTR2016-000568-41-CZ
(EUCTR)
05/01/201721/10/2016Filgotinib 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
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
40EUCTR2016-000568-41-GB
(EUCTR)
23/12/201613/10/2016Filgotinib 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-002852-26-LT
(EUCTR)
07/12/201624/10/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA 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]
Product Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
42NCT03016260
(ClinicalTrials.gov)
December 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
43EUCTR2016-002852-26-HU
(EUCTR)
15/11/201629/09/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA 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]
Product Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany;United Kingdom
44JPRN-UMIN000024025
2016/10/0101/10/2016The 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 applicableJapan
45NCT02833350
(ClinicalTrials.gov)
September 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02889796
(ClinicalTrials.gov)
August 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
47EUCTR2016-000335-40-BG
(EUCTR)
23/08/201608/07/2016A 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 Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
48EUCTR2015-003333-95-FI
(EUCTR)
10/08/201619/04/2016A 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: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
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
49EUCTR2015-003333-95-LT
(EUCTR)
21/07/201609/05/2016A 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
50EUCTR2015-003333-95-BG
(EUCTR)
13/07/201625/03/2016A 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2015-005307-83-PL
(EUCTR)
06/07/201601/06/2016Study 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: 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
52EUCTR2015-005307-83-HU
(EUCTR)
09/06/201628/04/2016Study 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: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: 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
53EUCTR2015-003433-10-CZ
(EUCTR)
08/06/201630/03/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
54EUCTR2015-003433-10-IT
(EUCTR)
08/06/201627/02/2018ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
HEXAL AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
55EUCTR2015-003433-10-HU
(EUCTR)
26/05/201614/04/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Malaysia;Poland;Romania;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
56EUCTR2015-003433-10-DE
(EUCTR)
25/05/201607/04/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
57NCT02760407
(ClinicalTrials.gov)
May 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
58EUCTR2015-003333-95-HU
(EUCTR)
18/05/201607/04/2016A 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: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
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
59EUCTR2015-003333-95-GR
(EUCTR)
12/05/201610/05/2016A 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
60EUCTR2015-003333-95-CZ
(EUCTR)
11/05/201622/04/2016A 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2015-003433-10-ES
(EUCTR)
09/05/201622/07/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
62EUCTR2015-003333-95-ES
(EUCTR)
06/05/201619/01/2016A 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: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
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
63EUCTR2015-003333-95-PT
(EUCTR)
06/05/201608/04/2016A 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
64NCT02668640
(ClinicalTrials.gov)
May 1, 201627/1/2016Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in ChinaReal-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study)Rheumatoid ArthritisBiological: AdalimumabAbbVieNULLCompleted18 YearsN/AAll55China
65EUCTR2015-003333-95-DE
(EUCTR)
25/04/201614/04/2016A 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2015-003333-95-IE
(EUCTR)
22/04/201608/04/2016A 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
67EUCTR2015-003333-95-LV
(EUCTR)
20/04/201612/04/2016A 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: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
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
68EUCTR2015-003333-95-AT
(EUCTR)
20/04/201612/04/2016A 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: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
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
69EUCTR2015-003333-95-DK
(EUCTR)
15/04/201607/04/2016A 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: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
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
70EUCTR2015-003333-95-GB
(EUCTR)
14/04/201611/04/2016A 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: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2015-003333-95-BE
(EUCTR)
13/04/201607/04/2016A 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: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
72NCT02750800
(ClinicalTrials.gov)
April 7, 201613/4/2016Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUERheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative ColitisBiological: Adalimumab;Behavioral: AbbVie Care 2.0AbbVieNULLCompleted18 Years99 YearsAll427Hungary
73EUCTR2015-003333-95-HR
(EUCTR)
05/04/201628/04/2016A 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
74NCT02722044
(ClinicalTrials.gov)
April 201623/3/2016Usability of an AI for M923 in Subjects With Moderate to Severe RAAn Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)Rheumatoid ArthritisBiological: M923;Device: AutoinjectorMomenta Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll33Phase 3United States
75NCT02744755
(ClinicalTrials.gov)
March 31, 201612/4/2016Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Adalimumab - GP2017;Biological: Adalimumab - US licensed HumiraSandozHexal AGCompleted18 YearsN/AAll353Phase 3United States;Czechia;Germany;Hungary;Italy;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2015-002634-41-DE
(EUCTR)
25/02/201610/11/2015 Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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]
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
77EUCTR2015-002634-41-BG
(EUCTR)
24/02/201621/12/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
78NCT02640612
(ClinicalTrials.gov)
January 22, 201618/12/2015Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid ArthritisLong-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With AdalimumabArthritis, RheumatoidDrug: BI 695501Boehringer IngelheimNULLCompleted18 Years80 YearsAll430Phase 3United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine
79EUCTR2015-002634-41-PL
(EUCTR)
20/01/201616/12/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of
80EUCTR2014-000358-13-DE
(EUCTR)
14/01/201631/07/2015A 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2015-002634-41-HU
(EUCTR)
07/01/201616/10/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
82NCT02878161
(ClinicalTrials.gov)
January 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
83EUCTR2014-000352-29-HR
(EUCTR)
29/12/201501/02/2016A 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 Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic 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
84JPRN-jRCT2071200058
21/12/201525/11/2020Bioequivalence study of FKB327 and adalimumab in healthy adult male subjectsA Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study Rheumatoid arthritis;D001172Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug
Yonemura TakumaNULLComplete>= 20age old< 45age oldMale130Phase 1Japan
85EUCTR2015-003333-95-SK
(EUCTR)
18/12/201504/11/2015A 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: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-004173-32-DK
(EUCTR)
18/12/201520/10/2015Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study. Rheumatic diseases
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Benepali
INN or Proposed INN: ETANERCEPT
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Department of Clinical Biochemestry, Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
500Phase 4Denmark
87EUCTR2015-002634-41-ES
(EUCTR)
17/12/201530/10/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
88NCT02629159
(ClinicalTrials.gov)
December 1, 201510/12/2015A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to MethotrexateA 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)Rheumatoid ArthritisDrug: Placebo for Adalimumab;Drug: Adalimumab;Drug: Placebo for Upadacitinib;Drug: UpadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll1629Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands
89EUCTR2013-002777-22-IT
(EUCTR)
19/11/201504/12/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 4France;Hungary;Spain;Denmark;Germany;Japan;United Kingdom;Italy
90NCT02557100
(ClinicalTrials.gov)
November 19, 20154/9/2015Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid ArthritisA Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: Abatacept;Drug: Adalimumab;Drug: MethotrexateBristol-Myers SquibbNULLCompleted18 YearsN/AAll80Phase 4United States;Canada;Mexico;Algeria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03172325
(ClinicalTrials.gov)
November 18, 201524/5/2017Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid ArthritisA Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid ArthritisActive Rheumatoid ArthritisDrug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PrednisoloneCinnagenNULLCompleted18 Years75 YearsAll136Phase 3NULL
92EUCTR2014-000352-29-BG
(EUCTR)
21/10/201531/08/2015A 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: 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.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
93EUCTR2014-000110-61-DE
(EUCTR)
15/10/201504/05/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
94JPRN-UMIN000020833
2015/10/0901/02/2016The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. Rheumatoid arthritisAdminister MTX 6-16mg/week for 12 weeks to patients with MDA-RA.
If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks.

Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks.
If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA.
Zenjinkai Shimin-no-mori HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female240Not selectedJapan
95EUCTR2015-002284-42-FI
(EUCTR)
18/09/201528/08/2015The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activitINTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specifyTrade Name: Enbrel
Product Name: etanercept
Trade Name: Humira
Product Name: adalimumab
Trade Name: Cimzia
Product Name: certolizumab pegol
Trade Name: Simponi
Product Name: golimumab
Trade Name: Remicade
Product Name: infliximab
READENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1650Phase 1Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02565810
(ClinicalTrials.gov)
September 201523/9/2015An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Adalimumab PFS and PenSamsung Bioepis Co., Ltd.NULLCompleted18 Years55 YearsAll49Phase 2Poland
97EUCTR2014-004887-39-PL
(EUCTR)
08/08/201507/07/2015A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., LtdNULLNot RecruitingFemale: yes
Male: yes
Poland
98EUCTR2014-000110-61-ES
(EUCTR)
06/07/201501/06/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
99NCT02480153
(ClinicalTrials.gov)
June 25, 201519/6/2015A 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 METHOTREXATERheumatoid ArthritisBiological: PF-06410293;Biological: AdalimumabPfizerNULLCompleted18 YearsN/AAll597Phase 3United States;Australia;Brazil;Bulgaria;Colombia;Czechia;Estonia;Georgia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Canada;Czech Republic
100EUCTR2014-000358-13-HR
(EUCTR)
08/06/201510/11/2015A 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: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1080Phase 3United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101JPRN-UMIN000017495
2015/06/0126/11/2015Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab rheumatoid arthritis(RA)dose maintain group: no change of treatment

MTX reducing group: reduce 2mg/week of MTX at ever 8 weeks. If remission is maintained at MTX 2mg/week, MTX will be stopped.

ADA spacing group: space the intervals of ADA for 1week at ever 8 weeks. If remission is maitained at the 6 weeks-intervals of ADA, ADA is stopped.
Keio University School of Medicine, Japan.NULLRecruitingNot applicableNot applicableMale and Female75Not selectedJapan
102EUCTR2014-000110-61-CZ
(EUCTR)
11/05/201504/05/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru
103EUCTR2014-002945-23-ES
(EUCTR)
30/04/201509/02/2015A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who?s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2Estonia;Czech Republic;Spain;Russian Federation;Latvia;United Kingdom
104NCT02393378
(ClinicalTrials.gov)
April 8, 201515/3/2015Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to MethotrexateA 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to MethotrexateRheumatoid ArthritisDrug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic AcidTakedaNULLTerminated18 YearsN/AAll7Phase 2Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic
105EUCTR2014-002541-22-DE
(EUCTR)
02/04/201509/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
540Phase 3United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;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
106JPRN-UMIN000016950
2015/03/2703/04/2015Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept rheumatoid arthritisInfliximab or adalimumab or golimumabOsaka Medical CollegeNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
107EUCTR2014-002541-22-GB
(EUCTR)
18/03/201509/01/2015Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
108EUCTR2014-000352-29-FR
(EUCTR)
16/03/201518/06/2015A 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 MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;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
109EUCTR2014-002945-23-GB
(EUCTR)
18/02/201504/11/2014 A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Takeda Development Centre Europe Ltd.NULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Czech Republic;Spain;Russian Federation;United Kingdom
110EUCTR2014-002945-23-CZ
(EUCTR)
18/02/201521/11/2014A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2Estonia;Czech Republic;Spain;Russian Federation;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2014-001114-26-SE
(EUCTR)
18/02/201526/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
112EUCTR2014-002541-22-ES
(EUCTR)
16/02/201522/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
340 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
113EUCTR2014-001114-26-NL
(EUCTR)
13/02/201524/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden
114EUCTR2014-002541-22-HU
(EUCTR)
11/02/201515/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
115NCT02332590
(ClinicalTrials.gov)
February 20155/1/2015Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Adalimumab;Drug: Placebo (for sarilumab);Drug: Placebo (for adalimumab)SanofiRegeneron PharmaceuticalsActive, not recruiting18 YearsN/AAll369Phase 3United States;Chile;Czechia;Germany;Hungary;Israel;Korea, Republic of;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2014-002541-22-CZ
(EUCTR)
26/01/201509/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
540Phase 3United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
117NCT02137226
(ClinicalTrials.gov)
January 26, 201512/5/2014BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid ArthritisEfficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator TrialArthritis, RheumatoidDrug: BI 695501;Drug: US-licensed Humira®Boehringer IngelheimNULLCompleted18 Years80 YearsAll645Phase 3United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;New Zealand;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine;Argentina;Colombia;Mexico;Philippines;South Africa
118EUCTR2013-004019-37-BG
(EUCTR)
26/01/201502/09/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
119EUCTR2014-000109-11-DE
(EUCTR)
22/01/201508/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
120EUCTR2014-000109-11-BG
(EUCTR)
21/01/201510/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2013-004019-37-DE
(EUCTR)
19/01/201524/07/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
122EUCTR2011-002067-20-FR
(EUCTR)
13/01/201523/08/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
123EUCTR2014-000358-13-ES
(EUCTR)
13/01/201522/09/2014A 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: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
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
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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
124NCT02198651
(ClinicalTrials.gov)
January 5, 201522/7/2014A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) SubjectsA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)Rheumatoid Arthritis;Musculoskeletal and Connective Tissue DiseasesBiological: Adalimumab;Other: PlaceboAbbVieNULLCompleted18 YearsN/AAll149Phase 4United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
125EUCTR2014-000352-29-EE
(EUCTR)
05/01/201507/08/2014A 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 MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE 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]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;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;Colombia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2014-000109-11-CZ
(EUCTR)
18/12/201409/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
127EUCTR2014-002945-23-EE
(EUCTR)
16/12/201427/11/2014A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. Rheumatoid Arthritis (RA)
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
9Phase 2Czech Republic;Estonia;Spain;Russian Federation;United Kingdom
128EUCTR2014-001114-26-GR
(EUCTR)
12/12/201402/12/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
129EUCTR2014-001114-26-IE
(EUCTR)
11/12/201414/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
130EUCTR2014-000352-29-DE
(EUCTR)
11/12/201413/10/2014A 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 MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE 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]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2014-000109-11-ES
(EUCTR)
09/12/201404/11/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
132EUCTR2014-000352-29-HU
(EUCTR)
05/12/201409/10/2014A 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 MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE 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]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
133EUCTR2014-000358-13-CZ
(EUCTR)
04/12/201404/08/2014A 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: 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]
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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
134EUCTR2014-000358-13-PL
(EUCTR)
03/12/201424/09/2014A 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: 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]
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
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
135EUCTR2013-001417-32-BG
(EUCTR)
27/11/201416/09/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2014-001114-26-GB
(EUCTR)
25/11/201414/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
137EUCTR2014-001114-26-ES
(EUCTR)
17/11/201401/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) Rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
138EUCTR2014-001114-26-FR
(EUCTR)
13/11/201418/06/2015A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden
139EUCTR2014-000358-13-EE
(EUCTR)
13/11/201407/08/2014A 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: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
140EUCTR2014-000358-13-GB
(EUCTR)
12/11/201412/09/2014A 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: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2014-001114-26-DE
(EUCTR)
10/11/201408/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
142EUCTR2014-000358-13-RO
(EUCTR)
10/11/201410/03/2015A 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: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1080Phase 3Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria
143EUCTR2014-000352-29-LT
(EUCTR)
06/11/201408/10/2014A 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 MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE 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]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
144EUCTR2014-000358-13-BG
(EUCTR)
06/11/201428/10/2014A 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: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
145EUCTR2014-001114-26-AT
(EUCTR)
05/11/201410/10/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2013-004019-37-HU
(EUCTR)
04/11/201431/07/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have 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] - Immune System Diseases [C20]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand;Poland;Czech Republic;Hungary;Canada
147EUCTR2014-001114-26-HU
(EUCTR)
04/11/201410/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
200Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
148JPRN-UMIN000015616
2014/11/0410/11/2014Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction rheumatoid arthritisAdalimumab plus Methotrexate
Tocilizumab plus Methotrexate
Biologic Mate Study GroupNULLComplete: follow-up complete20years-old75years-oldMale and Female300Not selectedJapan
149EUCTR2014-000352-29-GB
(EUCTR)
29/10/201409/10/2014A 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: 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]
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic 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
150EUCTR2014-000352-29-CZ
(EUCTR)
27/10/201405/08/2014A 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: 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]
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2014-000352-29-ES
(EUCTR)
23/10/201429/10/2014A 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 MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;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
152EUCTR2013-004019-37-RO
(EUCTR)
22/10/201405/03/2015A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Denmark;Australia;Bulgaria;Germany;New Zealand
153EUCTR2014-001114-26-IT
(EUCTR)
20/10/201416/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) Rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
154EUCTR2014-000358-13-LT
(EUCTR)
03/10/201411/09/2014A 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: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany
155NCT02150473
(ClinicalTrials.gov)
October 201427/2/2014The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) PatientsDelayed Gadolinium-enhanced Magnetic Resonance (MR) Imaging of Cartilage - A Pilot Study to Measure the Effect of Adalimumab Plus MTX Versus Placebo Plus MTX on Cartilage in Early RA PatientsRheumatoid ArthritisDrug: Adalimumab;Drug: PlaceboHeinrich-Heine University, DuesseldorfAbbottTerminated18 Years80 YearsAll21Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2014-000358-13-LV
(EUCTR)
26/09/201411/09/2014A 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: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 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
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
157EUCTR2012-002945-40-DE
(EUCTR)
22/09/201401/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
158NCT02097264
(ClinicalTrials.gov)
September 201424/3/2014A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to MethotrexateInflammation;Rheumatoid ArthritisDrug: NNC0109-0012;Drug: Adalimumab;Drug: placeboNovo Nordisk A/SNULLWithdrawn18 Years75 YearsBoth0Phase 2Ireland;Portugal;Spain;United Kingdom
159EUCTR2012-002945-40-BG
(EUCTR)
21/08/201405/08/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
160EUCTR2013-004604-19-DE
(EUCTR)
06/08/201403/06/2014Effect of Adalimumab plus Methortrexat (MTX) versus Placebo plus MTX on cartilage in early RA patientsDelayed Gadolinium-enhanced Magnetic resonance Imaging (MRI) of Cartilage - A pilot study to measure the effect of Adalimumab plus Methotrexat (MTX) versus Placebo plus MTX on cartilage in early rheumatoid arthritis (RA) patients patients with early progressive rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Trade Name: Humira 40mg Injektionslösung
Product Name: Humira
Heinrich-Heine-Universität DüsseldorfNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT02187055
(ClinicalTrials.gov)
August 20148/7/2014An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With MethotrexateA 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 ArthritisRhematoid ArthritisDrug: Tofacitinib with methotrexate;Drug: Tofacitinib without methotrexate;Biological: Adalimumab with methotrexatePfizerNULLCompleted18 YearsN/AAll1152Phase 4United States;Argentina;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Czechia;Estonia;Israel;Korea, Republic of;Latvia;Lithuania;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Croatia;Czech Republic;France
162EUCTR2012-002945-40-ES
(EUCTR)
07/07/201429/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial Rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
163JPRN-UMIN000016928
2014/07/0326/03/2015Targeted Ultrasound in Rheumatoid Arthritis Rheumatoid arthritisIf DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
Leeds UniversityNULLRecruiting18years-oldNot applicableMale and Female400Not selectedJapan,Europe
164NCT02141997
(ClinicalTrials.gov)
July 201416/5/2014A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateRheumatoid ArthritisBiological: adalimumab;Biological: ABT-122AbbVieNULLCompleted18 Years99 YearsAll222Phase 2Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey;United States
165EUCTR2013-001417-32-ES
(EUCTR)
30/06/201422/05/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2013-005013-13-PL
(EUCTR)
25/06/201431/03/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
167EUCTR2013-001417-32-LT
(EUCTR)
19/06/201407/04/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
168EUCTR2013-001417-32-DE
(EUCTR)
02/06/201418/02/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
169EUCTR2013-001417-32-HU
(EUCTR)
27/05/201417/03/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
170EUCTR2012-002945-40-HU
(EUCTR)
27/05/201404/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;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
171EUCTR2012-002945-40-EE
(EUCTR)
09/05/201410/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of
172NCT02167139
(ClinicalTrials.gov)
May 201416/6/2014A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: Humira (adalimumab);Drug: SB5 (proposed biosimilar to adalimumab)Samsung Bioepis Co., Ltd.NULLCompleted18 Years75 YearsAll544Phase 3Lithuania;Poland
173EUCTR2013-005013-13-BG
(EUCTR)
28/04/201423/04/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Phase 3Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
174EUCTR2013-005013-13-LT
(EUCTR)
08/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
175NCT02019472
(ClinicalTrials.gov)
April 4, 201418/12/2013A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidBiological: adalimumab 40 mg;Biological: sirukumab 100 mg;Biological: sirukumab 50 mg;Drug: PlaceboJanssen Research & Development, LLCGlaxoSmithKlineCompleted18 YearsN/AAll559Phase 3United States;Bulgaria;Chile;Colombia;Germany;Hungary;Lithuania;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;Argentina;Peru
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2013-005013-13-CZ
(EUCTR)
03/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
177EUCTR2013-000525-31-RO
(EUCTR)
24/03/201412/02/2015The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
178NCT02092467
(ClinicalTrials.gov)
March 14, 20143/3/2014Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid ArthritisPHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITISArthritis, RheumatoidDrug: tofacitinib;Biological: adalimumab;Biological: etanerceptPfizerNULLCompleted50 YearsN/AAll4368Phase 4United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden
179EUCTR2013-001492-20-PT
(EUCTR)
05/03/201424/01/2014A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateA randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate Rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Portugal;Spain;Ireland;United Kingdom
180EUCTR2013-001492-20-ES
(EUCTR)
31/01/201416/01/2014A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateA randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate Rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Portugal;Spain;Ireland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2013-000525-31-DE
(EUCTR)
10/01/201406/08/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
182EUCTR2013-001492-20-GB
(EUCTR)
24/12/201318/10/2013A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateA randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate Rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Portugal;Hungary;Czech Republic;Spain;Belgium;Poland;Ireland;Germany;Netherlands;Italy;United Kingdom
183EUCTR2013-002777-22-DE
(EUCTR)
17/12/201322/11/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLNot RecruitingFemale: yes
Male: yes
230Phase 4France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
184EUCTR2013-000525-31-BG
(EUCTR)
13/12/201321/11/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
185NCT02056184
(ClinicalTrials.gov)
December 201330/1/2014Targeted Ultrasound in Rheumatoid ArthritisTargeted Ultrasound in Rheumatoid ArthritisRheumatoid Arthritis;Targeted UltrasoundDrug: AdalimumabUniversity of LeedsAbbVie;TheoremCompleted18 YearsN/AAll183Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2013-000525-31-PL
(EUCTR)
17/11/201310/10/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
187EUCTR2013-002777-22-GB
(EUCTR)
14/11/201307/10/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLNot RecruitingFemale: yes
Male: yes
310Phase 4France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
188EUCTR2013-000525-31-CZ
(EUCTR)
21/10/201317/07/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
189EUCTR2013-000525-31-ES
(EUCTR)
12/10/201301/08/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
190NCT01970475
(ClinicalTrials.gov)
October 201323/10/2013Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid ArthritisArthritis, RheumatoidBiological: ABP 501;Biological: AdalimumabAmgenNULLCompleted18 Years80 YearsAll526Phase 3United States;Canada;Germany;United Kingdom;Bulgaria;Czech Republic;Hungary;Mexico;Poland;Romania;Russian Federation;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2013-000525-31-HU
(EUCTR)
26/09/201330/09/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
192EUCTR2012-001984-66-NO
(EUCTR)
11/09/201317/10/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5910United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Germany;Norway;New Zealand
193NCT01783015
(ClinicalTrials.gov)
September 201331/1/2013Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus MethotrexateA Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus MethotrexateRheumatoid ArthritisDrug: Etanercept;Drug: PlaceboPfizerNULLTerminated18 Years79 YearsAll16Phase 4Australia;Belgium;France;Hong Kong;Israel;Russian Federation;Spain;Netherlands
194EUCTR2013-000525-31-GB
(EUCTR)
27/08/201302/07/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
195EUCTR2012-003644-71-BE
(EUCTR)
08/07/201306/02/2013Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failureA Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2012-001984-66-LV
(EUCTR)
03/07/201325/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
197EUCTR2012-001984-66-IT
(EUCTR)
02/07/201307/05/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
198NCT01893996
(ClinicalTrials.gov)
July 20132/7/2013Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint DiseaseAdalimumab to Mitigate Cardiovascular Risk in RA Patients With Well-Controlled Joint DiseaseRheumatoid Arthritis;Cardiovascular DiseaseDrug: Adalimumab;Drug: PlaceboUniversity of California, San FranciscoAmerican College of Rheumatology Research and Education Foundation;AbbVieActive, not recruiting18 YearsN/AAll60Phase 4United States
199EUCTR2012-001984-66-DE
(EUCTR)
26/06/201306/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand
200EUCTR2012-001984-66-LT
(EUCTR)
20/06/201323/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;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
201EUCTR2012-004482-40-ES
(EUCTR)
18/06/201316/05/2013Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapiesEvaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized. Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: HUMIRA
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: ENBREL
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Trade Name: CIMZIA
Product Name: Certolizumab Pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: SIMPONI
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Product Name: Tocilizumab
INN or Proposed INN: TOCILIZUMAB
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
FRANCISCO J. BLANCO GARCÍANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
202EUCTR2012-001984-66-HU
(EUCTR)
06/06/201314/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - SARIL-RA-COMPARE Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
203NCT02132234
(ClinicalTrials.gov)
June 201328/4/2014Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisEffects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;HypertensionDrug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: InfliximabJagiellonian UniversityDepartmet of Rheumatology, J Dietl Hospital, Krakow, PolandRecruiting18 YearsN/ABoth100Phase 4Poland
204EUCTR2012-001984-66-FI
(EUCTR)
17/05/201324/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
205EUCTR2012-001984-66-GR
(EUCTR)
15/05/201323/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;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
206EUCTR2012-001984-66-CZ
(EUCTR)
13/05/201327/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand
207NCT01927757
(ClinicalTrials.gov)
May 6, 20135/6/2013Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to AdalimumabA Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic AgentModerate to Severe Rheumatoid ArthritisBiological: Etanercept;Drug: MethotrexateAmgenNULLTerminated18 YearsN/AAll90Phase 4United States;Canada;Puerto Rico
208NCT02035800
(ClinicalTrials.gov)
May 201310/12/2013Bone Resorption, Osteoclastogenesis and AdalimumabBone Resorption, Osteoclastogenesis and AdalimumabRheumatoId ArthritisDrug: AdalimumabUniversité de SherbrookeAbbVieUnknown status18 YearsN/AAll120Phase 4Canada
209EUCTR2012-001984-66-GB
(EUCTR)
25/04/201304/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
sanofi-aventis Recherche & DéveloppementNULLNot Recruiting Female: yes
Male: yes
5910 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
210EUCTR2012-001984-66-ES
(EUCTR)
25/04/201309/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;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
211EUCTR2012-002322-73-LT
(EUCTR)
16/04/201328/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
212EUCTR2012-003881-42-RO
(EUCTR)
09/04/201323/07/2014A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Puerto Rico;Romania;Germany
213NCT01764997
(ClinicalTrials.gov)
April 20138/1/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTXRheumatoid ArthritisDrug: Sarilumab;Drug: Etanercept;Drug: Methotrexate;Drug: Placebo (for sarilumab);Drug: Placebo (for etanercept);Drug: AdalimumabSanofiRegeneron PharmaceuticalsTerminated18 YearsN/AAll776Phase 3United States;Argentina;Australia;Brazil;Chile;Colombia;Czechia;Ecuador;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
214EUCTR2012-002322-73-SI
(EUCTR)
26/03/201319/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
215EUCTR2012-002322-73-DE
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2012-003881-42-DE
(EUCTR)
13/03/201309/01/2013A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Romania;Germany
217EUCTR2012-003644-71-ES
(EUCTR)
12/03/201321/12/2012Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failureA Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
168France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia
218EUCTR2012-002322-73-ES
(EUCTR)
20/02/201306/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
219EUCTR2012-002322-73-SK
(EUCTR)
12/02/201305/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
220NCT01768858
(ClinicalTrials.gov)
February 5, 201314/1/2013Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque PsoriasisDrug: AdalimumabAbbVieRaffeiner GmbHCompleted18 Years99 YearsAll96Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2012-002322-73-GR
(EUCTR)
24/01/201313/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Switzerland;France;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
222EUCTR2012-003881-42-BE
(EUCTR)
24/01/201318/12/2012A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Puerto Rico;Belgium;Romania;Germany
223EUCTR2012-003881-42-SK
(EUCTR)
23/01/201327/04/2016A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab 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: Body processes [G] - Immune system processes [G12]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Slovakia;Puerto Rico;Belgium;Romania;Germany
224EUCTR2012-002322-73-CZ
(EUCTR)
22/01/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
225EUCTR2012-002322-73-BE
(EUCTR)
21/01/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2012-002322-73-PT
(EUCTR)
18/01/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
227EUCTR2012-002322-73-NL
(EUCTR)
17/01/201317/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
228EUCTR2012-002322-73-HU
(EUCTR)
14/01/201327/11/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
229EUCTR2012-002322-73-LV
(EUCTR)
11/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
230EUCTR2011-002067-20-GR
(EUCTR)
10/01/201313/12/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2012-003644-71-NL
(EUCTR)
07/01/201307/01/2013Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failureA Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United StatesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands
232NCT01793519
(ClinicalTrials.gov)
January 201314/2/2013Stopping TNF Alpha Inhibitors in Rheumatoid ArthritisStopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical TrialRheumatoid ArthritisDrug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: PlaceboGeorgetown UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.Recruiting18 YearsN/AAll290Phase 4United States
233NCT01752855
(ClinicalTrials.gov)
December 201217/12/2012Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With AdalimumabRheumatoid ArthritisBiological: New formulation adalimumabAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll88Phase 2United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia
234EUCTR2012-000535-36-PL
(EUCTR)
18/10/201213/09/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
235EUCTR2012-002573-62-SE
(EUCTR)
12/10/201214/08/2012Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with AdalimumabDoppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab Rheumatoid arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: HumiraThe Karolinska Institute, ClinTRIDNULLNot RecruitingFemale: yes
Male: yes
120Phase 4Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT01736189
(ClinicalTrials.gov)
October 11, 201227/11/2012Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical PracticeAssessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)Rheumatoid ArthritisDrug: AdalimumabAbbVie (prior sponsor, Abbott)NULLCompleted16 Years99 YearsAll346Japan
237EUCTR2007-002066-35-SK
(EUCTR)
10/10/201215/04/2008A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
238JPRN-UMIN000010315
2012/10/0126/03/2013Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessmentPrediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study rheumatoid arthritisIn patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.Osaka City University Medical SchoolMetabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.The center for rheumatic diseases. Nara Medical University.Rheumatology. Kitano Hospital.Complete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
239NCT01609205
(ClinicalTrials.gov)
October 201229/5/2012Doppler Evaluation in RA Patients After Adalimumab.Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With AdalimumabRheumatoid ArthritisBiological: AdalimumabHamed RezaeiAbbottCompleted18 YearsN/AAll60Phase 4Sweden
240NCT01710358
(ClinicalTrials.gov)
October 201217/10/2012A Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate TherapyRheumatoid ArthritisDrug: Adalimumab;Drug: Baricitinib;Drug: Methotrexate;Drug: Adalimumab Placebo;Drug: Baricitinib PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll1307Phase 3United States;Argentina;Belgium;Canada;China;Croatia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;United Kingdom;Czech Republic;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2012-000535-36-DE
(EUCTR)
05/09/201215/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
242EUCTR2012-000535-36-BE
(EUCTR)
28/08/201205/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany
243EUCTR2012-000535-36-SK
(EUCTR)
23/08/201214/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
244EUCTR2011-002067-20-IT
(EUCTR)
23/08/201213/09/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwideA multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
UCB PHARMA SA/NV.NULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
245EUCTR2012-000535-36-CZ
(EUCTR)
02/08/201218/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2011-002067-20-GB
(EUCTR)
23/07/201213/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
UCB Pharma SANULLNot Recruiting Female: yes
Male: yes
892 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany
247EUCTR2011-002067-20-PT
(EUCTR)
06/07/201221/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
248EUCTR2011-002067-20-BG
(EUCTR)
28/06/201211/05/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
249EUCTR2011-002067-20-ES
(EUCTR)
26/06/201210/05/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
250EUCTR2011-002067-20-AT
(EUCTR)
26/06/201227/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2011-005204-15-AT
(EUCTR)
20/06/201215/05/2012Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und ImmunologieNULLNot RecruitingFemale: yes
Male: yes
110Phase 4Austria
252EUCTR2011-002067-20-CZ
(EUCTR)
19/06/201225/04/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
253EUCTR2011-002067-20-DE
(EUCTR)
13/06/201216/02/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
254EUCTR2011-002067-20-IE
(EUCTR)
01/06/201210/04/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany
255NCT01712178
(ClinicalTrials.gov)
June 201214/6/2012A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and SafetyStudy to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Adalimumab, current formulation;Biological: Adalimumab, new formulationAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll100Phase 2United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT01602302
(ClinicalTrials.gov)
June 201216/5/2012Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid ArthritisUltrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid ArthritisRheumatoid ArthritisDrug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)Medical University of GrazNULLTerminated18 Years90 YearsAll40Phase 4Austria
257EUCTR2011-002067-20-HU
(EUCTR)
30/05/201220/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
258EUCTR2011-002275-41-CZ
(EUCTR)
15/03/201228/12/2011A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Czech Republic;Belgium
259EUCTR2011-003953-25-DE
(EUCTR)
13/03/201204/01/2012A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
Product Code: L04 AB04
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Canada;Australia;Germany
260NCT01561313
(ClinicalTrials.gov)
March 201221/3/2012Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: AdalimumabAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll64Phase 2Belgium;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2011-002275-41-BE
(EUCTR)
31/01/201206/01/2012A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Czech Republic;Belgium
262NCT01502423
(ClinicalTrials.gov)
January 20121/12/2011A Crossover Study of the Safety and Tolerability of Two Formulations of AdalimumabA Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: AdalimumabAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll61Phase 2Australia;Canada;Germany
263NCT01500278
(ClinicalTrials.gov)
December 201122/12/2011Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to MethotrexateA Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to MethotrexateRheumatoid ArthritisBiological: Certolizumab Pegol (CZP);Biological: Adalimumab (ADA);Drug: Methotrexate (MTX)UCB Pharma SAParexelCompleted18 YearsN/AAll915Phase 4United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Monaco;Poland;Portugal;Romania;Spain;Switzerland;United Kingdom;Czech Republic
264EUCTR2010-023956-99-CZ
(EUCTR)
29/11/201117/06/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 (v1.0, dated 09-Oct-2014) RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of;United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil
265NCT01592292
(ClinicalTrials.gov)
November 201111/4/2012An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha TherapyA Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF AgentRheumatoid ArthritisDrug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: InfliximabHoffmann-La RocheNULLCompleted20 YearsN/AAll90N/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
266NCT01954381
(ClinicalTrials.gov)
October 201113/10/2011Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid ArthritisImpact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid ArthritisRheumatoid ArthritisDevice: transthoracic echocardiographic;Device: Doppler ultrasound.;Biological: blood samplesAssistance Publique Hopitaux De MarseilleNULLCompleted18 YearsN/ABoth60Phase 3France
267EUCTR2010-023956-99-DE
(EUCTR)
22/09/201101/06/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
268EUCTR2010-023692-26-SK
(EUCTR)
09/09/201113/09/2011Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
269EUCTR2010-023587-40-NL
(EUCTR)
06/09/201111/05/2011A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain
270EUCTR2010-023956-99-HU
(EUCTR)
17/08/201118/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT01295151
(ClinicalTrials.gov)
August 201111/2/2011SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking DrugRheumatoid ArthritisDrug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: GolimumabJulia BrownNULLCompleted18 YearsN/ABoth122Phase 4United Kingdom
272JPRN-UMIN000013750
2011/07/3121/04/2014Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis Rheumatoid arthritis, PeriodontitisIL-6 receptor inhibition group:
Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

TNF inhibition group:
Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.
Division of Periodontology, Niigata University Graduate School of Medical and Dental SciencesNULLComplete: follow-up completeNot applicableNot applicableMale and Female80Not selectedJapan
273EUCTR2010-023956-99-NL
(EUCTR)
28/07/201130/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Protocol Amendment 03 (v1.0, dated 08-Mar-2011) RHEUMATOID ARTHRITIS,NOS
MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
274EUCTR2010-023956-99-BE
(EUCTR)
20/07/201124/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
275EUCTR2010-023956-99-ES
(EUCTR)
20/07/201103/11/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) - RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
677Phase 2Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2010-023956-99-IT
(EUCTR)
11/07/201101/03/2012A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal
Product Code: BMS-945429
INN or Proposed INN: NA
Other descriptive name: anti IL 6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: NA
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
BRISTOL-M.SQUIBBNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
277JPRN-JapicCTI-111628
01/7/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate. Rheumatoid ArthritisIntervention name : Clazakizumab
Dosage And administration of the intervention : Injection, 25 mg, 100 mg, 200 mg
Control intervention name : Methotrexate,Adalimumab
Dosage And administration of the control intervention : Methotrexate:Oral,7.5 mg, Adalimumab:Injection,40mg
Bristol-Myers K.K.NULL18BOTH406Phase 2NULL
278EUCTR2010-023587-40-DE
(EUCTR)
14/06/201102/03/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
279NCT01373151
(ClinicalTrials.gov)
June 201113/6/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.Rheumatoid ArthritisDrug: BMS-945429 Placebo;Biological: BMS-945429;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: Adalimumab Placebo;Drug: AdalimumabCSL BehringNULLCompleted18 YearsN/AAll418Phase 2United States;Argentina;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Czech Republic;Peru
280EUCTR2010-023587-40-GR
(EUCTR)
10/05/201116/05/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. Adult Rheumatoid Arthritis (RA)
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2010-023587-40-SE
(EUCTR)
04/05/201114/03/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA randomized, open-label, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
96United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
282NCT01283971
(ClinicalTrials.gov)
May 201125/1/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-InhibitorA Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF InhibitorRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folateHoffmann-La RocheNULLTerminated18 YearsN/AAll96Phase 4United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom
283NCT01405326
(ClinicalTrials.gov)
May 201130/6/2011REstore Working Ability in RheumatoiD ArthritisThe Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to WorkRheumatoid ArthritisBiological: adalimumabThe Rheumatological Center of HelsinkiAbbottRecruiting25 Years55 YearsBoth160Phase 4Finland
284EUCTR2010-023587-40-DK
(EUCTR)
28/04/201112/04/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 4United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden
285EUCTR2010-019514-24-CZ
(EUCTR)
21/04/201106/12/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX Goldshield Tablets
INN or Proposed INN: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2010-023587-40-FI
(EUCTR)
15/04/201124/02/2011A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
96Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
287EUCTR2010-023587-40-ES
(EUCTR)
13/04/201117/02/2011A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF. Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Finland;Germany;Netherlands;Spain;Italy;Greece;Sweden
288EUCTR2010-023692-26-GB
(EUCTR)
07/04/201118/11/2010Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany
289EUCTR2010-019514-24-DE
(EUCTR)
04/04/201108/11/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO Rheumatoid Arthritis.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380United States;Czech Republic;Puerto Rico;Canada;Argentina;Spain;Austria;Germany
290EUCTR2010-021577-37-BG
(EUCTR)
24/03/201104/02/2011A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti Lymphotoxin Alpha
Product Code: MLTA3698A
Other descriptive name: Anti lymphotoxin alpha
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Mexico;Spain;Peru;Chile;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2010-023692-26-BG
(EUCTR)
17/03/201124/02/2011Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
370Phase 2Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany
292EUCTR2010-021577-37-DE
(EUCTR)
17/03/201129/10/2010A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Spain;Bulgaria;Germany
293EUCTR2010-023587-40-IT
(EUCTR)
10/03/201127/04/2011A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - NDA randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
294EUCTR2010-023692-26-CZ
(EUCTR)
16/02/201122/12/2010Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
295EUCTR2010-023692-26-HU
(EUCTR)
04/02/201108/02/2011Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 Rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT02092961
(ClinicalTrials.gov)
February 201119/3/2014Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-StudyA Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-StudyRheumatoid ArthritisDrug: Fostamatinib;Drug: Adalimumab;Drug: Placebo of Fostamatinib;Drug: Placebo of AdalimumabAstraZenecaNULLTerminated18 YearsN/AAll198Phase 2United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;South Africa;United Kingdom
297EUCTR2010-021577-37-ES
(EUCTR)
27/01/201123/11/2010ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Artritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Germany;Bulgaria;Spain
298EUCTR2010-019514-24-ES
(EUCTR)
27/01/201130/11/2010Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTOEstudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO Rheumatoid Arthritis. Artritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METOTREXATO
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380Czech Republic;Spain;Austria;Germany
299EUCTR2010-019514-24-AT
(EUCTR)
27/01/201121/12/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Austria;Germany
300EUCTR2010-019514-24-BE
(EUCTR)
25/01/201125/11/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO Rheumatoid Arthritis.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380Phase 3United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT01264770
(ClinicalTrials.gov)
January 201117/12/2010Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Fostamatinib and placebo injections;Drug: Adalimumab and placebo of fostamatinib;Drug: Placebo of fostamatinib, fostamatinib, and placebo injectionsAstraZenecaNULLTerminated18 YearsN/AAll644Phase 2United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Ukraine;United Kingdom
302NCT01382160
(ClinicalTrials.gov)
January 20112/12/2010Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)Rheumatoid ArthritisBiological: adalimumabUniversity Hospital, ToursNULLCompleted18 YearsN/ABoth69Phase 4France
303NCT01270035
(ClinicalTrials.gov)
January 20114/1/2011Efficacy and Safety of Adalimumab 80 mg Every Other Week With MethotrexateRheumatoid ArthritisDrug: AdalimumabKeio UniversitySaitama Medical UniversityRecruitingN/AN/ABoth40Phase 4Japan
304EUCTR2010-021577-37-HU
(EUCTR)
16/12/201027/10/2010A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Spain;Bulgaria;Germany
305NCT01225393
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placeboGenentech, Inc.NULLCompleted18 Years75 YearsBoth211Phase 2Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2010-021449-28-FR
(EUCTR)
04/10/201009/08/2010Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORAValeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORA Polyarthrite rhumatoïde
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB
CHRU de TOURSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
307EUCTR2009-015845-21-GR
(EUCTR)
04/10/201004/10/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
308EUCTR2009-015845-21-PT
(EUCTR)
01/10/201022/07/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
309NCT01185301
(ClinicalTrials.gov)
October 201018/8/2010Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)Early Rheumatoid ArthritisBiological: adalimumab;Drug: methotrexateAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll395Phase 3United States;Argentina;Austria;Belgium;Canada;Czech Republic;Germany;Poland;Puerto Rico;Spain
310NCT01197144
(ClinicalTrials.gov)
October 20103/9/2010Pain Modulation in Rheumatoid Arthritis (RA) - Influence of AdalimumabPain Modulation in RA - Influence of Adalimumab. A Randomized, Placebo-controlled Study Using Functional Magnetic Resonance Imaging (PARADE)Arthritis, Rheumatoid;Pain;FatigueDrug: adalimumab;Drug: PlaceboKarolinska InstitutetAbbott;Swedish Foundation for Strategic Research;The Swedish Research CouncilCompleted18 YearsN/AAll70N/ASweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT01162421
(ClinicalTrials.gov)
September 201025/5/2010A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid ArthritisRadiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: adalimumab;Drug: MethotrexateAbbVie (prior sponsor, Abbott)Mount Sinai Hospital, CanadaCompleted18 Years99 YearsAll77Phase 4Canada
312NCT01185288
(ClinicalTrials.gov)
September 201018/8/2010A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA)Rheumatoid ArthritisBiological: Adalimumab;Drug: MethotrexateAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll309Phase 4United States;Puerto Rico
313EUCTR2009-015845-21-DE
(EUCTR)
22/07/201018/03/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden
314EUCTR2009-015845-21-CZ
(EUCTR)
16/07/201026/03/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
315EUCTR2009-015845-21-SE
(EUCTR)
06/07/201010/05/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316JPRN-UMIN000003880
2010/07/0107/07/2010Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area Rheumatoid arthritisDAS28>3.2 at 24 weeks
Switching to another biologics
DAS28>3.2 at 24 weeks
Dose up of MTX or addition of other DMARDs
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every two week
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every four week
Osaka City University Medical SchoolHigashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu HospitalRecruiting20years-oldNot applicableMale and Female100Not applicableJapan
317EUCTR2009-015845-21-FI
(EUCTR)
16/06/201030/04/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
318EUCTR2009-010582-23-GR
(EUCTR)
15/06/201030/12/2009A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?) Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal
Product Name: Golimumab prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
319EUCTR2009-015845-21-BE
(EUCTR)
08/06/201004/05/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
320EUCTR2009-017163-42-SE
(EUCTR)
18/05/201023/03/2010Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADEPain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Humira.Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Karolinska InstituteNULLNot RecruitingFemale: yes
Male: yes
Phase 4Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2009-015845-21-GB
(EUCTR)
13/05/201017/03/2010A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritisA multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
322EUCTR2009-015740-42-DE
(EUCTR)
12/05/201012/01/2010A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETROA PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Prednisolon
Product Code: Prednisolon
INN or Proposed INN: PREDNISOLONE
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
Other descriptive name: AZATHIOPRINE
Trade Name: Immunosporin
Product Name: Immunosporin
INN or Proposed INN: CICLOSPORIN
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: GOLIMUMAB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Product Name: Quensyl
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: REMICADE
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Lantarel
Product Name: Lantarel
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Lantarel
Trade Name: Arava
Product Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Metex 2,5mg
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Metex 2,5mg
Universitätsklinkum ErlangenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Germany
323EUCTR2009-015845-21-ES
(EUCTR)
12/05/201012/01/2012A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity.A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis. Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Portugal;Germany;Switzerland;Turkey;Sweden;Australia;Brazil;Finland;United Kingdom;Czech Republic;Mexico;Belgium;Spain;Greece;United States
324NCT01119859
(ClinicalTrials.gov)
May 20101/4/2010A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid ArthritisA Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Tocilizumab;Drug: Adalimumab;Drug: Placebo to tocilizumab;Drug: Placebo to adalimumabHoffmann-La RocheNULLCompleted18 YearsN/AAll326Phase 4United States;Australia;Belgium;Brazil;Czech Republic;Finland;Germany;Greece;Mexico;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom;Norway
325NCT01163617
(ClinicalTrials.gov)
May 20104/5/2010The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis PatientsA Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis PatientsRheumatoid ArthritisDevice: Adalimumab delivered in current syringe;Device: Adalimumab delivered in Physiolis syringe;Device: Adalimumab delivered in current autoinjector;Device: Adalimumab delivered in Physiolis autoinjectorAbbVie (prior sponsor, Abbott)NULLCompleted18 YearsN/AAll85Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326EUCTR2009-017379-90-IT
(EUCTR)
27/04/201031/03/2010Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - NDCharacterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
INN or Proposed INN: ETANERCEPT AZIENDA OSPEDALIERA SENESENULLNot RecruitingFemale: yes
Male: yes
Italy
327NCT01060098
(ClinicalTrials.gov)
April 201029/1/2010T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF BlockadeT Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha AgentsRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: anti-TNF therapy (etanercept or adalimumab)Imperial College LondonNULLCompleted18 Years80 YearsAll48United Kingdom
328NCT01021735
(ClinicalTrials.gov)
April 201027/11/2009Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic TherapyOptimal Management of Rheumatoid Arthritis Patients Requiring Biologic TherapyRheumatoid ArthritisDrug: etanercept or adalimumab;Drug: RituximabUniversity of GlasgowArthritis Research Campaign;NHS Lothian;NHS Grampian;NHS Tayside;NHS Borders;NHS FifeCompleted18 YearsN/ABoth302Phase 4United Kingdom
329EUCTR2009-010582-23-IT
(EUCTR)
10/03/201008/01/2010A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - NDA Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: golimumab
Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: golimumab
CENTOCORNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
330EUCTR2009-017325-19-FI
(EUCTR)
11/02/201028/12/2009The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work”The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work” Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Term: Rheumatoid arthritis
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB
Helsingin reumakeskusNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331EUCTR2009-010582-23-BE
(EUCTR)
10/02/201023/09/2009Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
332EUCTR2009-010582-23-DE
(EUCTR)
04/01/201022/09/2009A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
333EUCTR2009-010582-23-GB
(EUCTR)
31/12/200928/06/2010Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen Biologics B.V.NULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGreece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden
334EUCTR2009-011268-13-GB
(EUCTR)
31/12/200915/03/2010Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT studyOptimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: MabThera
Product Name: Rituximab
Trade Name: Enbrel
Product Name: Etanercept
Trade Name: Humira
Product Name: Adalimumab
NHS Greater Glasgow and ClydeUniversity of GlasgowNot RecruitingFemale: yes
Male: yes
United Kingdom
335EUCTR2009-010582-23-SE
(EUCTR)
16/12/200923/10/2009A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT01000441
(ClinicalTrials.gov)
December 200922/10/2009Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRheumatoid ArthritisDrug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumabUniversity Hospital, Strasbourg, FranceNULLRecruiting18 YearsN/ABoth300Phase 4France;Monaco
337NCT01004432
(ClinicalTrials.gov)
December 200929/10/2009Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)Arthritis;Arthritis, Rheumatoid;Autoimmune DiseasesDrug: Golimumab 50 mg SC;Drug: Golimumab 2 mg/kg IV;Drug: Methotrexate (MTX);Drug: Placebo SC;Drug: Placebo IVJanssen Biotech, Inc.Merck Sharp & Dohme Corp.Completed18 YearsN/AAll433Phase 3United States;Austria;Belgium;Canada;Germany;Greece;Sweden;United Kingdom;France;Spain
338NCT01029613
(ClinicalTrials.gov)
December 20099/12/2009Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating BiomarkersAdalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble BiomarkersRheumatoid ArthritisDrug: AdalimumabGlostrup University Hospital, CopenhagenNULLCompleted18 Years85 YearsBoth40N/ADenmark
339EUCTR2009-010582-23-AT
(EUCTR)
26/11/200912/10/2009Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
340EUCTR2007-003288-36-GB
(EUCTR)
04/11/200903/10/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Centocor BVNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2008-005450-20-BE
(EUCTR)
29/10/200901/10/2009The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME) Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade (infliximab)
INN or Proposed INN: INFLIXIMAB
Other descriptive name: remicade
Trade Name: Humira (adalimumab)
INN or Proposed INN: ADALIMUMAB
Trade Name: Enbrel (etanercept)
INN or Proposed INN: ETANERCEPT
Other descriptive name: Enbrel
Trade Name: Mabthera (rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: Mabthera
Trade Name: Orencia (abatacept)
INN or Proposed INN: ABATACEPT
Other descriptive name: Orencia
Radboud University Nijmegen Medical Centre, department of Rheumatic DiseasesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Belgium
342EUCTR2009-014394-41-DK
(EUCTR)
12/10/200923/09/2009Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)