107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04585711
(ClinicalTrials.gov)
July 20237/10/2020Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With ArthritisPharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With ArthritisJuvenile Idiopathic Arthritis;Rheumatoid Arthritis;ObesityDrug: Etanercept Optimal dosingDuke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruiting2 Years65 YearsAll30Phase 1United States
2EUCTR2017-002018-29-HU
(EUCTR)
04/01/202225/10/2021Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);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
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden
3EUCTR2021-004031-86-IT
(EUCTR)
21/12/202120/09/2021Efficacy and safety of anti TNF-alfa biosimilar compared to originators in Juvenile Idiopathic ArthritisA randomized, two-armed, single-blind, parallel, active controlled, and non-inferiority clinical trial to Compare Efficacy and Safety ofanti TNF-alfa biosimilar molecules to the originators in children with active Juvenile Idiopathic Arthritis” - CEST-JIA Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Adalimumab biosimilare
Product Code: [Adalimumab biosimilare]
INN or Proposed INN: ADALIMUMAB
Other descriptive name: biosimilar adalimumab
Product Name: Adalimumab biosimilare
Product Code: [Adalimumab biosimilare]
INN or Proposed INN: ADALIMUMAB
Other descriptive name: biosimilar adalimumab
Trade Name: 40 MG- SOLUZIONE INIETTABILE IN SIRINGHE PRE-RIEMPITE- USO SOTTOCUTANEO- SIRINGA PRERIEMPITA (0,4ML)- 2 SIRINGHE PRE-RIEMPITE + 2 TAMPONI IMBEVUTI DI ALCOOL
Product Name: Humira
Product Code: [Abalimumab bio-originatore]
INN or Proposed INN: ADALIMUMAB
Other descriptive name: originator adalimumab
Product Name: Etanercept biosimilare
Product Code: [Etanercept biosimilare]
INN or Proposed INN: ETANERCEPT
Other descriptive name: biosimilar Etanercept
Product Name: Etanercept biosimilare
Product Code: [Etanercept biosimilare]
INN or Proposed INN: ETANERCEPT
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 4Italy
4EUCTR2021-001577-24-ES
(EUCTR)
15/12/202125/08/2021A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE).
MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
5EUCTR2021-001577-24-PL
(EUCTR)
31/10/202128/09/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE).
MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Germany;Netherlands;China;Japan;Sweden
6EUCTR2017-002018-29-NL
(EUCTR)
19/10/202110/12/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);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
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden
7EUCTR2019-002788-88-NL
(EUCTR)
23/09/202118/02/2021Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Belgium;Austria;Netherlands;Italy
8NCT05027373
(ClinicalTrials.gov)
August 13, 202117/8/2021Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1ß Humanized Monoclonal Antibody InjectionA Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1ß Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy SubjectsSystemic Juvenile Idiopathic Arthritis;Periodic Fever SyndromeDrug: SSGJ-613;Drug: PlaceboSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.NULLRecruiting18 Years45 YearsAll34Phase 1China
9EUCTR2015-004000-35-IE
(EUCTR)
24/06/202119/02/2021A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Argentina;Poland;Bulgaria;Netherlands;Germany;Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada
10NCT04902807
(ClinicalTrials.gov)
June 202121/5/2021Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and InflammationConception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and InflammationAutoimmune Lymphoproliferative Syndrome;Autoimmune Cytopenia;Autoimmune Diseases;Autoimmune Anemia;Autoimmune Thrombocytopenia;Autoimmune Hepatitis;Autoimmune Diabetes;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Juvenile Idiopathic Arthritis;Hemophagocytic Lymphohistiocytoses;EBV Lymphoproliferation;RAS-Associated Autoimmune Leucoproliferative Disease;Primary Immunodeficiency;APECED;IPEX;BENTA;Enteropathy, Autoimmune;Combined Immunodeficiency;IBDBiological: Collection of samplesInstitut National de la Santé Et de la Recherche Médicale, FranceNULLNot yet recruiting1 Year18 YearsAll500NULL
11EUCTR2019-002788-88-FR
(EUCTR)
15/04/202118/12/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Belgium;Austria;Netherlands
12NCT04527380
(ClinicalTrials.gov)
April 13, 202124/8/2020A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisJuvenile Psoriatic Arthritis;Enthesitis Related ArthritisDrug: Ixekizumab;Drug: AdalimumabEli Lilly and CompanyNULLRecruiting2 Years17 YearsAll100Phase 3Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom
13EUCTR2019-002788-88-IT
(EUCTR)
11/03/202120/05/2021Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) - PEAPOD Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast 20 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE
Product Name: Apremilast 30 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast 10 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Spain;Belgium;Austria;Netherlands;Germany;Italy
14EUCTR2018-000681-10-CZ
(EUCTR)
25/02/202122/12/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
15EUCTR2017-002018-29-DE
(EUCTR)
02/02/202123/09/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);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
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Eritrea;South Africa;Netherlands;Germany;China;Sweden
16EUCTR2015-004000-35-BG
(EUCTR)
12/01/202112/11/2020A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Bulgaria;Netherlands;Germany
17NCT04775225
(ClinicalTrials.gov)
January 6, 202117/2/2021Hip Denervation in Juvenile Idiopathic Arthritis With Hip ArthritisHip Denervation in Juvenile Idiopathic ArthritisJuvenile Idiopathic Arthritis;Hip ArthritisDrug: Lidocaine;Drug: PlaceboSohag UniversityNULLCompleted2 Years18 YearsAll120Phase 3Egypt
18EUCTR2018-000681-10-IT
(EUCTR)
23/12/202024/05/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis - TALZ Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
INN or Proposed INN: ixekizumab
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: Adalimumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
19EUCTR2017-002018-29-IT
(EUCTR)
15/12/202006/11/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS - . Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: [CP-690, 550-10]
INN or Proposed INN: Tofacitinib
Product Name: tofacitinib citrate
Product Code: [CCP-690-550-10]
INN or Proposed INN: Tofacitinib
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Netherlands;Germany;China;Sweden
20EUCTR2018-000681-10-DK
(EUCTR)
14/12/202031/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
21EUCTR2017-002018-29-SK
(EUCTR)
09/12/202004/08/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;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
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden
22NCT04614311
(ClinicalTrials.gov)
December 1, 202028/10/2020Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA).Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): The MyJIA Trial.Juvenile Idiopathic ArthritisDrug: Triamcinolone Hexacetonide 20 MG/MLOslo University HospitalThe Research Council of Norway;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North Norway;Helse Stavanger HFRecruiting1 Year18 YearsAll202Phase 4Norway
23NCT04687930
(ClinicalTrials.gov)
December 1, 202019/12/2020Genicular Nerve Block in Juvenile Idiopathic ArthritisGenicular Nerve Block in Juvenile Idiopathic ArthritisJuvenile Idiopathic Arthritis;Persistent Knee Arthritis;no Intra-articular Injection in the Last 3 Months;no Other Cause for Chronic KneearthritisDrug: genicular nerve block;Drug: intra-articular steroid injectionSohag UniversityNULLCompletedN/A16 YearsAll104Phase 4Egypt
24EUCTR2018-000681-10-GB
(EUCTR)
24/11/202011/09/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom
25EUCTR2018-000681-10-DE
(EUCTR)
23/11/202007/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
26EUCTR2017-002018-29-PL
(EUCTR)
28/10/202009/08/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);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
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;South Africa;Netherlands;Germany;China;Sweden
27EUCTR2019-000889-38-NO
(EUCTR)
16/09/202018/06/2020Personalised treatment of my juvenile arthritisStrategies towards personalised treatment in Juvenile Idiopathic Arthritis (JIA): An open randomised multicentre blinded-assessor trial assessing the effectiveness of intra-articular glucocorticoid injections in JIA patients starting tumour necrosis factor inhibitor treatment - MyJIA Juvenile idiopathic arthritis is characterised by inflamed joints and is the most common chronic rheumatic disease in childhood and adolescence that potentially lead to disability due to joint damage. A prerequisite for the JIA diagnosis is the detection of inflammation of one or more joints (arthritis). Arthritis leads to pain, swelling and stiffness of the affected joints, caused by hypertrophy of the synovial lining of the joint and increased synovial fluid. Untreated, disability may follow.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Lederspan
INN or Proposed INN: TRIAMCINOLONE HEXACETONIDE
Oslo University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
202Phase 4Norway
28NCT04397107
(ClinicalTrials.gov)
August 15, 20206/5/2020The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic DiseasesThe Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)Systemic Lupus ErythematosusDrug: IL-2The First Hospital of Jilin UniversityNULLRecruitingN/A17 YearsAll46N/AChina
29NCT03816397
(ClinicalTrials.gov)
March 3, 202022/1/2019Adalimumab in JIA-associated Uveitis Stopping TrialAdalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping TrialUveitis;JIABiological: Adalimumab;Other: PlaceboNisha AcharyaChildren's Hospital of Philadelphia;Children's Hospital Medical Center, Cincinnati;Children's Mercy Hospital Kansas City;National Eye Institute (NEI);Great Ormond Street Hospital for Children NHS Foundation Trust;University Hospitals Bristol and Weston NHS Foundation Trust;Alder Hey Children's NHS Foundation Trust;Johns Hopkins University;Children's Hospital Los Angeles;Seattle Children's Hospital;Newcastle-upon-Tyne Hospitals NHS Trust;University Hospital Southampton NHS Foundation Trust;Sheffield Children's NHS Foundation Trust;Royal Children's Hospital;Children's Health;Sydney Children's Hospitals NetworkRecruiting2 YearsN/AAll118Phase 4United States;Australia;United Kingdom
30EUCTR2018-004284-30-DE
(EUCTR)
13/02/202029/07/2019Repsonse to Treatment with Canakinumab without steroids early after diagnosis of systemic onset juvenile idiopathic arthritis / juvenile Still’s diseaseEffectiveness of Canakinumab for first line steroid free treatment in systemic onset juvenile idiopathic arthritis / juvenile Still’s disease - CANAKINUMAB FIRST systemic juvenile idiopathic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ilaris
Product Name: Ilaris
Asklepios Klink Sankt AugustinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Germany
31NCT04088396
(ClinicalTrials.gov)
February 12, 202011/9/2019A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIARandomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic ArthritisSystemic Juvenile Idiopathic ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLRecruiting1 Year17 YearsAll103Phase 3Argentina;Austria;Belgium;Brazil;Czechia;Denmark;France;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom;Germany
32EUCTR2019-000119-10-DE
(EUCTR)
20/01/202025/06/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Spain;Germany;United Kingdom;Italy
33EUCTR2017-004495-60-PL
(EUCTR)
12/12/201923/10/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China
34EUCTR2017-004495-60-DK
(EUCTR)
20/11/201921/11/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Japan;China;Germany;Denmark;Brazil;Belgium;Poland;Argentina;Mexico;Czech Republic;France;India;Italy;United Kingdom;Israel;Russian Federation;Austria;Turkey;Spain;Czechia
35NCT03841357
(ClinicalTrials.gov)
October 29, 201930/1/2019Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)Juvenile Idiopathic ArthritisDrug: Abatacept Injection;Other: Usual CareDuke UniversityNULLRecruiting2 Years16 YearsAll306Phase 3United States
36EUCTR2019-000412-29-GB
(EUCTR)
18/10/201925/03/2019Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST) - ADJUST juvenile-idiopathic arthritispaediatric uveitis
MedDRA version: 20.0;Level: LLT;Classification code 10022557;Term: Intermediate uveitis;System Organ Class: 100000004853
MedDRA version: 20.0;Classification code 10033687;Term: Panuveitis;System Organ Class: 100000004853
MedDRA version: 20.1;Classification code 10036370;Term: Posterior uveitis;System Organ Class: 100000004862
MedDRA version: 20.1;Classification code 10066681;Term: Acute uveitis;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
F.I. Proctor Foundation, University of California San FranciscoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
118Phase 4United States;Australia;United Kingdom
37NCT04088409
(ClinicalTrials.gov)
October 16, 201911/9/2019A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive UveitisAn Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive UveitisUveitisDrug: Baricitinib;Drug: AdalimumabEli Lilly and CompanyNULLRecruiting2 Years17 YearsAll40Phase 3France;Germany;Italy;Spain;United Kingdom
38EUCTR2017-004471-31-FR
(EUCTR)
15/10/201905/08/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
39EUCTR2019-000119-10-IT
(EUCTR)
08/10/201917/06/2021A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
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: SUB180983
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: [Humira]
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: ADALIMUMAB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;European Union;Germany;United Kingdom;Italy
40EUCTR2017-004518-24-FR
(EUCTR)
03/10/201905/08/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
41EUCTR2017-004495-60-FR
(EUCTR)
24/09/201910/07/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
97Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan
42EUCTR2017-004495-60-IT
(EUCTR)
16/09/201917/06/2021A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less Than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;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
Product Name: OLUMIANT
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Product Name: OLUMIANT
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan
43EUCTR2017-004495-60-GB
(EUCTR)
19/08/201911/07/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China
44EUCTR2019-000119-10-FR
(EUCTR)
14/08/201929/05/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Germany;United Kingdom
45EUCTR2017-004471-31-BE
(EUCTR)
09/08/201906/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
410Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
46EUCTR2019-000119-10-GB
(EUCTR)
06/08/201917/04/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Germany;United Kingdom
47NCT04169828
(ClinicalTrials.gov)
August 2, 201918/11/2019The Ondansetron Premedication Trial in Juvenile Idiopathic ArthritisThe Ondansetron Premedication Trial in Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: Methotrexate;Drug: Ondansetron;Drug: Folic/folinic acidUniversity of British ColumbiaThe Arthritis Society, Canada;University of Calgary;IWK Health Centre;The Hospital for Sick Children;McGill University Health Centre/Research Institute of the McGill University Health Centre;London Health Sciences Centre;University of Manitoba;Children's Hospital of Eastern Ontario;Alberta Children's Hospital;McMaster University;McMaster Children's Hospital;Université de Montréal;Royal University Hospital Foundation;Memorial University of NewfoundlandRecruiting4 Years16 YearsAll176N/ACanada
48EUCTR2017-004471-31-DE
(EUCTR)
17/07/201903/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
236 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
49EUCTR2017-004518-24-BE
(EUCTR)
16/07/201914/08/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
50NCT04018599
(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
51EUCTR2017-004518-24-PL
(EUCTR)
09/07/201927/06/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
52EUCTR2017-004471-31-PL
(EUCTR)
02/07/201919/06/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
53EUCTR2017-004518-24-DE
(EUCTR)
27/06/201903/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
54NCT03725007
(ClinicalTrials.gov)
June 24, 201927/10/2018A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic ArthritisAn Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic ArthritisJuvenile Idiopathic Arthritis (JIA)Drug: UpadacitinibAbbVieNULLRecruiting2 Years17 YearsAll124Phase 1United States;Germany;Hungary;Israel;Italy;Puerto Rico;Spain
55EUCTR2017-004471-31-DK
(EUCTR)
13/06/201901/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Germany;Japan;China
56EUCTR2017-004518-24-DK
(EUCTR)
13/06/201930/04/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Germany;Japan;China
57NCT03984669
(ClinicalTrials.gov)
June 11, 201911/6/2019(1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy(1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort SudyJuvenile Idiopathic ArthritisDiagnostic Test: The Juvenile Disease Activity Score (JADAS);Biological: (1-3)-ß-D-Glucan (BDG) assay (Fungitell)Centre Hospitalier Universitaire, AmiensNULLRecruitingN/A18 YearsAll40N/AFrance
58NCT03769168
(ClinicalTrials.gov)
June 7, 201921/11/2018An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related ArthritisJuvenile Psoriatic Arthritis;Enthesitis Related ArthritisDrug: AIN457Novartis PharmaceuticalsNULLActive, not recruiting2 YearsN/AAll56Phase 3United States;Belgium;Germany;Italy;Poland;Russian Federation;South Africa;Spain;Turkey
59EUCTR2017-004471-31-GB
(EUCTR)
29/05/201913/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
60EUCTR2017-004518-24-CZ
(EUCTR)
27/05/201902/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) - JUVE-BASIS Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Germany;China;Japan
61EUCTR2017-004471-31-ES
(EUCTR)
27/05/201929/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
236 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
62EUCTR2017-004471-31-CZ
(EUCTR)
27/05/201903/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
63EUCTR2017-004518-24-AT
(EUCTR)
22/05/201907/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
64EUCTR2017-004518-24-ES
(EUCTR)
22/05/201927/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
65EUCTR2018-000715-25-ES
(EUCTR)
21/05/201927/05/2019Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis Polyarticular Course Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 1;Phase 3United States;Hungary;Spain;Germany;Italy
66EUCTR2017-004471-31-IT
(EUCTR)
21/05/201915/06/2021A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) - NA Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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]
Trade Name: Olumiant
Product Name: OLUMIANT
Product Code: [LY3009104]
Product Name: olumiant
Product Code: [LY3009104]
Product Name: Olumiant
Product Code: [LY3009104]
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
67EUCTR2017-004518-24-IT
(EUCTR)
17/05/201917/06/2021A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) - na Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: oluminant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: Baricitinib
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
68EUCTR2018-002521-30-DE
(EUCTR)
09/05/201908/01/2019An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 3United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy
69EUCTR2017-004518-24-GB
(EUCTR)
23/04/201907/02/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
70NCT04337437
(ClinicalTrials.gov)
April 22, 20191/4/2020Clinical Study of Genakumab for Injection in Chinese Healthy VolunteersThe Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Genakumab for Injection in Chinese Healthy VolunteersJuvenile Idiopathic ArthritisDrug: Genakumab;Drug: Placebo for this trialGeneScience Pharmaceuticals Co., Ltd.Peking Union Medical College HospitalRecruiting18 Years50 YearsAll40Phase 1China
71EUCTR2015-001438-46-PL
(EUCTR)
16/04/201930/01/2018Efficacy Study Of Tofacitinib In Pediatric JIA Population EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany
72EUCTR2018-002521-30-IT
(EUCTR)
16/04/201915/06/2021An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis - Secukinumab long-term safety, tolerability and efficacy in JPsA and ERA up to 4 years Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 2 SIRINGHE PRERIEMPITE
Product Name: -
Product Code: [-]
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: [AIN457]
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 3United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy
73EUCTR2018-000715-25-DE
(EUCTR)
16/04/201907/01/2019Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis Polyarticular Course Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1United States;Hungary;Spain;Germany;Italy
74NCT03932344
(ClinicalTrials.gov)
April 10, 201916/4/2019Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic ArthritisStill Disease, Juvenile OnsetDrug: AnakinraSwedish Orphan BiovitrumNULLCompletedN/AN/AAll306Italy
75NCT03773965
(ClinicalTrials.gov)
April 5, 201911/12/2018A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic ArthritisA Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic ArthritisDrug: BaricitinibEli Lilly and CompanyNULLRecruiting1 Year18 YearsAll190Phase 3Argentina;Australia;Austria;Belgium;Brazil;China;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom
76EUCTR2018-000715-25-IT
(EUCTR)
20/03/201917/06/2021Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis - na Polyarticular Course Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: Upadacitinib
Other descriptive name: na
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: Upadacitinib
Other descriptive name: na
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: Upadacitinib
Other descriptive name: na
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: Upadacitinib
Other descriptive name: na
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 1United States;Hungary;Spain;Germany;Italy
77EUCTR2018-000715-25-HU
(EUCTR)
18/03/201923/01/2019Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis Polyarticular Course Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
54 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Spain;Germany;Italy
78EUCTR2018-002521-30-ES
(EUCTR)
15/03/201927/03/2019An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
63 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Belgium;Spain;Turkey;Russian Federation;South Africa;Germany;Italy
79EUCTR2018-001931-27-IT
(EUCTR)
28/02/201911/10/2018Comparison of therapeutic strategies in childhood ARthritiSComparison of STep-up and step-down therapeutic strategies in childhood ARthritiS - the STARS trial Juvenile idiopathic arthritis (JIA) is an umbrella term that encompasses a heterogeneous group of disorders characterised by prolonged synovial inflammation that may cause destructive damage to joint structures. Permanent changes may also develop in extraarticular organs, particularly the eye (as a complication of chronic anterior uveitis), or may result from side effects of medications.
MedDRA version: 20.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Reumaflex
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
IRCCS Istituto Giannina GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Italy
80EUCTR2018-002245-11-NL
(EUCTR)
16/01/201920/08/2018A study to investigate Vitamin B3 concentrations in the joint after intake Assessing penetration of high dose Nicotinamide (Vitamin B3) in synovial fluid - B-Vit in the joint Juvenile Idiopathic Arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: nicotinamide
Product Code: 98-92-0
INN or Proposed INN: NICOTINAMIDE
Other descriptive name: Vitamin B3
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
6 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
81NCT03773978
(ClinicalTrials.gov)
December 17, 201811/12/2018A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic ArthritisA Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLCompleted2 Years17 YearsAll220Phase 3Argentina;Australia;Austria;Belgium;Brazil;China;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom
82NCT03833271
(ClinicalTrials.gov)
October 28, 201821/1/2019The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From HungaryThe Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy ControlJuvenile Idiopathic ArthritisBiological: Influenza vaccine, Immune functionUniversity of PecsNULLCompleted3 Years18 YearsAll62Early Phase 1Hungary
83NCT02991469
(ClinicalTrials.gov)
August 9, 201814/10/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension PhaseJuvenile Idiopathic ArthritisDrug: Sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsRecruiting1 Year17 YearsAll72Phase 2Argentina;Bulgaria;Canada;Czechia;Finland;France;Germany;Ireland;Italy;Russian Federation;Spain;United Kingdom;Chile;Estonia;Netherlands;Poland;United States
84EUCTR2016-004223-23-NL
(EUCTR)
09/08/201813/02/2018A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Novimmune SANULLNot RecruitingFemale: yes
Male: yes
10Phase 2France;United States;Canada;Spain;Germany;Netherlands;United Kingdom;Italy
85NCT03000439
(ClinicalTrials.gov)
May 10, 20189/11/2016A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIAEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTSArthritis Juvenile IdiopathicDrug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratioPfizerNULLRecruiting2 Years17 YearsAll100Phase 3United States;Argentina;Belgium;Brazil;Canada;China;Costa Rica;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Chile
86NCT03301883
(ClinicalTrials.gov)
April 26, 201821/9/2017A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: Tocilizumab;Drug: NSAIDs;Drug: CSs;Drug: MTXHoffmann-La RocheNULLActive, not recruiting2 Years17 YearsAll74Phase 4China
87EUCTR2015-001438-46-DE
(EUCTR)
16/04/201813/12/2017Efficacy Study Of Tofacitinib In Pediatric JIA PopulationEFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FORTREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHICARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany
88EUCTR2015-001438-46-ES
(EUCTR)
05/04/201821/12/2017Efficacy Study Of Tofacitinib In Pediatric JIA Population EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany;South Africa;Australia;Brazil;Belgium;Poland;Argentina;Canada;Mexico;United Kingdom;Switzerland;Chile;Israel;Russian Federation;Turkey;Ukraine;Spain;United States
89EUCTR2011-004915-22-GB
(EUCTR)
03/04/201821/12/2017A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3New Zealand;Germany;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;United Kingdom;Turkey;South Africa;Peru;Australia;Switzerland;Italy;Russian Federation;Chile;Israel;Ukraine;Spain;Slovakia;Taiwan;Philippines;United States
90EUCTR2015-001438-46-GB
(EUCTR)
27/03/201828/11/2017Efficacy Study Of Tofacitinib In Pediatric JIA PopulationEFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FORTREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHICARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Switzerland;United Kingdom;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;South Africa;Germany
91EUCTR2011-004915-22-BE
(EUCTR)
16/03/201802/01/2018A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNAFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;India;Peru;Australia;South Africa;Netherlands;China;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden
92NCT03311854
(ClinicalTrials.gov)
February 20, 201821/8/2017A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFN?) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset Still DiseaseDrug: EmapalumabSwedish Orphan BiovitrumNULLCompletedN/AN/AAll14Phase 2United States;France;Italy;Spain;United Kingdom;Netherlands
93EUCTR2015-001438-46-BE
(EUCTR)
19/02/201806/12/2017Efficacy Study Of Tofacitinib In Pediatric JIA Population EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany
94NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
95ChiCTR-OPB-17013704
2017-12-202017-12-05A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritisA phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis systemic juvenile idiopathic arthritisCase series:Tocilizumab;Children's Hospital of Chongqing Medical UniversityNULLRecruiting217BothCase series:65;Phase 4China
96EUCTR2015-004000-35-DE
(EUCTR)
16/11/201719/09/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands
97EUCTR2016-004223-23-ES
(EUCTR)
25/09/201709/06/2017A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Other descriptive name: NI-0501
Novimmune SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 2France;Spain;Netherlands;Germany;Italy;United Kingdom
98EUCTR2016-004223-23-GB
(EUCTR)
12/09/201702/03/2017A study to investigate a new medication, emapalumab, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Swedish Orphan Biovitrum AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Canada;Spain;Netherlands;Italy;United Kingdom
99NCT03092427
(ClinicalTrials.gov)
September 4, 201721/3/2017Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic ArthritisDietary Supplement: VSL#3;Other: PlaceboAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting1 Year7 YearsAll51N/AFrance
100ChiCTR-INR-17011829
2017-08-012017-07-02Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumabMultiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab Systemic onset juvenile idiopathic arthritisCase:Tocilizumab;Control:Conventional Treatment;Shenzhen Children's HospitalNULLPendingBothCase:75;Control:75;China
101EUCTR2016-003761-26-PL
(EUCTR)
30/06/201724/05/2017Secukinumab safety and efficacy in JPsA and ERAA three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Spain;Belgium;Poland;Turkey;South Africa;Russian Federation;Germany;United Kingdom;Italy
102EUCTR2016-003761-26-BE
(EUCTR)
15/06/201716/03/2017Secukinumab safety and efficacy in JPsA and ERAA three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;United Kingdom;Italy
103NCT03031782
(ClinicalTrials.gov)
May 23, 20172/11/2016Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related ArthritisJuvenile Psoriatic Arthritis;Enthesitis-related ArthritisDrug: AIN457;Other: Matched placeboNovartis PharmaceuticalsNULLCompleted2 Years17 YearsAll86Phase 3United States;Belgium;Germany;Italy;Poland;Russian Federation;South Africa;Spain;Turkey;United Kingdom
104NCT02840175
(ClinicalTrials.gov)
May 18, 201719/7/2016Treatment Tapering in JIA With Inactive DiseaseTreatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic TherapyJuvenile Idiopathic ArthritisDrug: etanercept;Drug: adalimumab;Drug: Abatacept;Drug: TocilizumabAssistance Publique - Hôpitaux de ParisNULLCompleted2 Years17 YearsAll62Phase 3France
105EUCTR2015-004000-35-NL
(EUCTR)
19/04/201707/12/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Netherlands;Germany
106EUCTR2016-004223-23-IT
(EUCTR)
14/04/201725/01/2017A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: NI-0501Novimmune SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 2France;Spain;Netherlands;Germany;United Kingdom;Italy
107EUCTR2016-003761-26-GB
(EUCTR)
10/03/201713/12/2016Secukinumab safety and efficacy in JPsA and ERAA three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy;United Kingdom
108EUCTR2016-003761-26-ES
(EUCTR)
01/03/201715/12/2016Secukinumab safety and efficacy in JPsA and ERAA three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 19.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Poland;Belgium;Spain;Turkey;South Africa;Russian Federation;Netherlands;Germany;United Kingdom;Italy
109EUCTR2015-004000-35-GB
(EUCTR)
24/02/201718/08/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands
110EUCTR2015-003999-79-DE
(EUCTR)
22/02/201714/07/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP Juvenile idiopathic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany
111EUCTR2015-004000-35-PL
(EUCTR)
13/02/201705/12/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
72Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany
112EUCTR2016-003761-26-DE
(EUCTR)
06/02/201712/12/2016Secukinumab safety and efficacy in JPsA and ERAA three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 3United States;Poland;Belgium;Spain;Turkey;Russian Federation;South Africa;Germany;Italy;United Kingdom
113NCT03069638
(ClinicalTrials.gov)
February 1, 201720/12/2016Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric PopulationIntranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric PopulationJuvenile Idiopathic Arthritis;Joint InflammationDrug: Dexmedetomidine;Drug: Sedatives/Hypnotics,OtherUniversity of OuluNULLRecruiting1 Year18 YearsAll109Phase 4Finland
114EUCTR2015-004000-35-FI
(EUCTR)
12/12/201606/10/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Bulgaria;Germany;Netherlands
115EUCTR2015-004000-35-EE
(EUCTR)
15/11/201604/10/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase Juvenile Idiopathic Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany
116EUCTR2015-004000-35-ES
(EUCTR)
10/11/201626/09/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase Juvenile Idiopathic Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany
117EUCTR2015-004000-35-IT
(EUCTR)
17/10/201607/09/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase Juvenile Idiopathic Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany
118EUCTR2015-004393-16-NL
(EUCTR)
04/10/201608/07/2016Biomarker-guided treatment-and-stop-strategy for short acting IL-1 blockade in patients with systemic Juvenile Idiopathic Arthritis.Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis. - ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA systemic Juvenile Idiopathic Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: kineret® or anakinra
Product Name: anakinra / kineret
Product Code: not applicable
INN or Proposed INN: ANAKINRA
Other descriptive name: rIL-1RA
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
119EUCTR2015-003999-79-NL
(EUCTR)
28/09/201601/06/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase Juvenile idiopathic arthritis
MedDRA version: 19.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany
120JPRN-UMIN000024178
2016/09/2828/09/2016Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis Systemic-onset juvenile idiopathic arthritis(sJIA)Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeksYokohama City University Hospital Department of PediatricsNULLRecruiting2years-oldNot applicableMale and Female5Not selectedJapan
121NCT02776735
(ClinicalTrials.gov)
September 6, 201616/5/2016An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension PhaseJuvenile Idiopathic ArthritisDrug: SarilumabSanofiRegeneron PharmaceuticalsActive, not recruiting2 Years17 YearsAll100Phase 2United States;Argentina;Canada;Chile;Czechia;Finland;France;Germany;Italy;Mexico;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Czech Republic;Estonia
122ChiCTR-OPC-17011391
2016-09-012017-05-12The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in ChinaThe efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China systemic juvenile idiopathic arthritistocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid;Children's Hospital of Chongqing Medical UniversityNULLCompleted216Bothtocilizumab group:36;glucocorticoid group:24;China
123EUCTR2015-003999-79-PL
(EUCTR)
22/08/201607/07/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase Juvenile idiopathic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Canada;Argentina;Poland;Netherlands;Germany;Mexico;Czech Republic;France;Italy;United Kingdom;Chile;Russian Federation;Spain;Finland;Estonia;United States
124EUCTR2016-000312-15-FR
(EUCTR)
12/08/201617/06/2016Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREMTreatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology.
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: ENBREL
Product Name: ENBREL
INN or Proposed INN: Etanercept
Other descriptive name: Etanercept
Trade Name: HUMIRA
Product Name: HUMIRA
INN or Proposed INN: adalimumab
Other descriptive name: adalimumab
Trade Name: ROACTEMRA
Product Name: ROACTEMRA
INN or Proposed INN: tocilizumab
Other descriptive name: tocilizumab
Trade Name: ORENCIA
Product Name: ORENCIA
INN or Proposed INN: abatacept
Other descriptive name: abatacept
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
230Phase 3France
125EUCTR2015-003999-79-IT
(EUCTR)
10/06/201607/03/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase Juvenile idiopathic arthritis
MedDRA version: 18.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany
126NCT02592434
(ClinicalTrials.gov)
June 10, 201614/8/2015Efficacy Study Of Tofacitinib In Pediatric JIA PopulationEFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTSJuvenile Idiopathic ArthritisDrug: CP-690,550 (tofacitinib);Other: placeboPfizerNULLCompleted2 Years17 YearsAll225Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Israel;Mexico;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom;Chile;Germany;South Africa;Switzerland
127EUCTR2015-003999-79-FI
(EUCTR)
23/05/201622/04/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP Juvenile idiopathic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands
128EUCTR2015-003999-79-CZ
(EUCTR)
11/05/201609/03/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase Juvenile idiopathic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany
129EUCTR2015-003999-79-ES
(EUCTR)
04/05/201618/03/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase Juvenile idiopathic arthritis
MedDRA version: 18.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany
130EUCTR2014-003260-20-NL
(EUCTR)
04/05/201617/11/2015CHAMP Trial: comparing monotherapy and polytherapy treatment strategies in newly diagnosed juvenile idiopathic arthritis.CHAMP: Children with Arthritis: Monotherapy or Polytherapy. A multicentre, single-blinded, randomized treat to target, one-year follow-up clinical trial in patients with recent onset Juvenile Idiopathic Arthritis (JIA). - CHAMP Juvenile idiopathic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: sulfasalazine
Product Name: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Other descriptive name: SULFASALAZINE
Trade Name: Hydroxychloroquine
Product Name: Hydroxychloroquine
INN or Proposed INN: HYDROXYCHLOROQUINE
Other descriptive name: HYDROXYCHLOROQUINE
Leiden University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 4Netherlands
131EUCTR2015-000435-33-GB
(EUCTR)
18/08/201517/07/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
132EUCTR2015-000435-33-BE
(EUCTR)
12/08/201519/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Spain;Belgium;Russian Federation;Germany;Italy;United Kingdom
133EUCTR2014-004887-39-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
134EUCTR2015-000435-33-DE
(EUCTR)
07/08/201510/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1United Kingdom;Italy;Germany;Russian Federation;Spain;Belgium;Poland;Hungary;France
135EUCTR2015-000435-33-HU
(EUCTR)
27/07/201510/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
136EUCTR2015-000435-33-PL
(EUCTR)
07/07/201503/07/2015A study to assess the pharmacokinetics and safety of tocilizumab inpatients less than 2 years old with Active Systemic Juvenile IdiopathicArthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Belgium;Spain;Poland;Russian Federation;Germany;Italy;United Kingdom
137EUCTR2015-001323-23-GB
(EUCTR)
03/07/201501/05/2015A study of Tocilizumab in patients with JIA associated Uveitis who have not responded to treatment with an anti-TNF. A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis. - APTITUDE Juvenile Idiopathic Arthritis with Associated Uveitis
MedDRA version: 18.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Tocilizumab
Product Name: Tocilizumab
Product Code: Ro 487-7533/F10
INN or Proposed INN: Tocilizumab
Other descriptive name: RoActemra
University Hospitals Bristol NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
22 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
138EUCTR2015-000435-33-ES
(EUCTR)
26/06/201529/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Roche Farma S.A en nombre de F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
139NCT02396212
(ClinicalTrials.gov)
May 7, 201525/2/2015Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIAAn Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisBiological: CanakinumabNovartis PharmaceuticalsNULLCompleted2 Years19 YearsAll19Phase 3Japan
140ChiCTR-OOC-15006228
2015-04-012015-04-09Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritisClinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritis systemic-onset juvenile idiopathic arthritisdisease active group,disease remission group:add heparin into neutrophils in vitro;Shanghai Children's Medical CenterNULLRecruiting316Bothdisease active group,disease remission group:30;China
141JPRN-JapicCTI-152865
01/4/2015Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIAAn Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) Systemic Juvenile Idiopathic ArthritisIntervention name : ACZ885
INN of the intervention : Canakinumab
Dosage And administration of the intervention : 4mg/kg every 4 weeks
Control intervention name : null
Novartis Pharma K.K.NULL219BOTH20Phase 3NULL
142EUCTR2013-004867-29-NL
(EUCTR)
23/12/201423/09/2014Study of efficacy and safety of dose reduction or dose interval prolongation of canakinumab in patients with SJIAAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885G2306 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 19.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
143NCT02277444
(ClinicalTrials.gov)
December 17, 201427/10/2014A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate TherapyA Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate TherapyArthritis, JuvenileDrug: Golimumab;Drug: MethotrexateJanssen Research & Development, LLCNULLActive, not recruiting2 Years17 YearsAll130Phase 3United States;Argentina;Brazil;Canada;Chile;Israel;Mexico;Russian Federation;South Africa;Puerto Rico
144EUCTR2013-004867-29-DE
(EUCTR)
28/11/201425/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
145NCT02296424
(ClinicalTrials.gov)
November 17, 201410/10/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic Arthritis (SJIA)Drug: ACZ885 150 mg (Canakinumab)Novartis PharmaceuticalsNULLCompleted2 Years20 YearsAll182Phase 3United States;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Turkey;Argentina;Hong Kong;Mexico
146EUCTR2013-004867-29-BE
(EUCTR)
07/11/201429/09/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
147EUCTR2013-004867-29-HU
(EUCTR)
04/11/201425/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
148NCT02334748
(ClinicalTrials.gov)
November 3, 201423/12/2014A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 StudiesA French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)Systemic Juvenile Idiopathic Arthritis;Hereditary Periodic FeversDrug: canakinumabNovartis PharmaceuticalsNULLCompleted5 Years20 YearsAll31Phase 3France
149EUCTR2013-004867-29-ES
(EUCTR)
20/10/201406/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
150EUCTR2013-004867-29-IT
(EUCTR)
03/10/201426/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
NOVARTIS FARMA S.p.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
151EUCTR2014-002872-95-FR
(EUCTR)
15/09/201418/06/2015A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1A French open-label extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who participated in the international phase III study CACZ885G2301E1 - CACZ885GFR01 Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma S.A.SNULLNot RecruitingFemale: yes
Male: yes
15Phase 4France
152EUCTR2013-004867-29-SE
(EUCTR)
10/09/201425/07/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
153EUCTR2013-004867-29-AT
(EUCTR)
04/09/201431/07/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
154NCT02165345
(ClinicalTrials.gov)
July 16, 201413/6/2014Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic ArthritisLong-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted2 Years18 YearsAll82Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
155EUCTR2013-005212-98-IT
(EUCTR)
09/07/201420/05/2014Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
96Phase 1United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
156EUCTR2013-005212-98-DE
(EUCTR)
30/06/201419/05/2014Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic ArthritisLONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
104Phase 1United States;France;Mexico;Canada;Argentina;Spain;Brazil;Australia;Russian Federation;Germany;United Kingdom;Italy
157EUCTR2013-005013-13-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
158EUCTR2013-005212-98-ES
(EUCTR)
16/06/201409/06/2014Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Roche Farma S.A. en nombre de F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
159EUCTR2013-005212-98-GB
(EUCTR)
21/05/201420/05/2014Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
104 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
160EUCTR2013-003956-18-NL
(EUCTR)
29/04/201413/01/2014Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA)Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA) - PREVENT-JIA juvenile idiopathic arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: enbrel
Product Name: enbrel
Product Code: EU/1/99/126/001
INN or Proposed INN: ETANERCEPT
Other descriptive name: enbrel
Trade Name: humira
Product Name: humira
Product Code: EU/1/03/256/001
INN or Proposed INN: ADALIMUMAB
Other descriptive name: humira
Trade Name: orencia
Product Name: orencia
Product Code: EU/1/07/389/001
INN or Proposed INN: ABATACEPT
Other descriptive name: orencia
Trade Name: methotrexate
Product Name: methotrexate
Product Code: RVG 28636
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Trade Name: methotrexate
Product Name: Methotrexate
Product Code: RVG 104433
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325United States;Canada;Latvia;Germany;Netherlands
161EUCTR2013-005013-13-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
162EUCTR2013-005013-13-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
163EUCTR2013-005013-13-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
164NCT02052167
(ClinicalTrials.gov)
April 201427/1/2014Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic ArthritisHuman Factors Study for the Evaluation of the Methotrexate Prefilled Pen (50 mg/mL) for Subcutaneous Injection in Pediatric and Adolescent Patients With Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDevice: methotrexate prefilled penmedac GmbHPPDCompleted2 Years20 YearsAll30Early Phase 1United States
165NCT02067962
(ClinicalTrials.gov)
March 5, 201413/2/2014Identification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome SequencingIdentification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome SequencingArthritis, Juvenile RheumatoidBiological: Blood sampleUniversity Hospital, MontpellierNULLCompleted1 Month40 YearsAll30N/ANULL
166EUCTR2012-002067-10-NL
(EUCTR)
30/01/201424/09/2013Adult bonemarrow stem cells for treatment of juvenile arthritis in childhoodMesenchymal stromal cells for treatment of drug resistantpediatric Juvenile idiopathic arthritis - MSC-JIA juvenile idiopathic arthritis
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Mesenchymal Stromal Cells
Product Code: TC-MSC
INN or Proposed INN: mesenchymal stromal cells
Other descriptive name: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
167NCT01603355
(ClinicalTrials.gov)
November 201318/5/2012Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated UveitisAn Open-label Trial to Assess the Efficacy and Safety of Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Vision-threatening Uveitis That is Refractory to Other Modes of Systemic ImmunosuppressionJuvenile Idiopathic Arthritis Associated UveitisDrug: TocilizumabEric B. SuhlerGenentech, Inc.Terminated2 Years17 YearsAll3Phase 1/Phase 2United States
168EUCTR2012-003195-39-IT
(EUCTR)
08/10/201322/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03. Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy
169EUCTR2012-003195-39-BE
(EUCTR)
07/10/201309/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11Site specific Protocol Amendment 13 dated 17-July-2015 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy
170EUCTR2012-003195-39-ES
(EUCTR)
17/09/201312/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy
171JPRN-JapicCTI-132119
12/9/201307/05/2013Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan.A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics. Juvenile Idiopathic Arthritis.Intervention name : Abatacept
INN of the intervention : Abatacept
Dosage And administration of the intervention : Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Bristol-Myers Squibb K.K.Ono Pharmaceutical Co., Ltd.complete417BOTH20Phase 3Japan
172EUCTR2012-003195-39-DE
(EUCTR)
26/08/201308/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11Site specific Protocol Amendment 13 dated 17-July-2015Site specific Protocol Amendment 12 dated 02-July-2015 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 18.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy
173EUCTR2012-003486-18-PL
(EUCTR)
19/08/201302/07/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Australia;Peru;Germany
174NCT01904292
(ClinicalTrials.gov)
August 15, 201314/6/2013A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic ArthritisA Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted1 Year17 YearsAll52Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
175EUCTR2012-005026-30-HU
(EUCTR)
15/08/201320/02/2013A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® 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 SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
498Phase 3Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
176NCT01835470
(ClinicalTrials.gov)
August 9, 201317/4/2013Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in JapanA Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or BiologicsJuvenile Idiopathic ArthritisDrug: AbataceptBristol-Myers SquibbOno Pharmaceutical Co. LtdCompleted4 Years17 YearsAll23Phase 3Japan
177EUCTR2012-003486-18-DE
(EUCTR)
08/08/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany;United States;Spain;Russian Federation;United Kingdom;Italy
178EUCTR2012-003490-26-DE
(EUCTR)
08/08/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
179EUCTR2011-004915-22-IT
(EUCTR)
22/07/201321/09/2012A long-term, open label, study for treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FORTREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
PFIZER INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Hungary;Mexico;Argentina;Poland;Russian Federation;Germany;Italy
180NCT01904279
(ClinicalTrials.gov)
July 201314/6/2013A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted1 Year17 YearsAll52Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom;Peru;Poland
181NCT01844518
(ClinicalTrials.gov)
June 28, 201329/4/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)Active Polyarticular Juvenile Idiopathic ArthritisBiological: AbataceptBristol-Myers SquibbNULLActive, not recruiting2 Years17 YearsAll187Phase 3United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation;South Africa;Spain
182EUCTR2012-003486-18-ES
(EUCTR)
28/06/201326/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany
183EUCTR2012-003490-26-ES
(EUCTR)
26/06/201326/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
184EUCTR2012-003486-18-GB
(EUCTR)
14/06/201320/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany
185EUCTR2012-003490-26-GB
(EUCTR)
14/06/201320/06/2013 A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
186EUCTR2012-003490-26-IT
(EUCTR)
11/06/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;United Kingdom;Italy
187EUCTR2012-003486-18-IT
(EUCTR)
11/06/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany
188NCT01734382
(ClinicalTrials.gov)
June 10, 201322/11/2012A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis (SJIA) Who Experience Laboratory Abnormalities During Treatment With TocilizumabJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted2 Years17 YearsAll35Phase 4United States;Argentina;Canada;Germany;Israel;Italy;Mexico;Russian Federation;Spain;United Kingdom;Australia;Norway;Sweden
189NCT02024334
(ClinicalTrials.gov)
June 201310/12/2013Efficacy Study of Leflunomide to Treat Juvenile Idiopathic ArthritisStudy of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: LeflunomideMashhad University of Medical SciencesNULLRecruiting2 Years19 YearsBoth30Phase 4Iran, Islamic Republic of
190EUCTR2012-005026-30-PL
(EUCTR)
17/05/201308/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® 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 SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
191EUCTR2012-005026-30-CZ
(EUCTR)
15/05/201322/02/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® 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 SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
192EUCTR2012-003054-92-CZ
(EUCTR)
18/04/201318/12/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;Sweden
193EUCTR2012-005026-30-BG
(EUCTR)
10/04/201305/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® 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 SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
194NCT01500551
(ClinicalTrials.gov)
March 18, 201322/12/2011Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)Juvenile Idiopathic ArthritisDrug: TofacitinibPfizerNULLRecruiting2 Years18 YearsAll340Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Germany;Israel;Mexico;Poland;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Chile;Hungary;Switzerland
195NCT01727986
(ClinicalTrials.gov)
March 20138/11/2012An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 StudyExtension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977)Juvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted9 Years18 YearsBoth11Phase 3Brazil
196NCT01513902
(ClinicalTrials.gov)
March 201317/1/2012Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)An Open-label Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Pediatric Patients From 2 To Less Than 18 Years Of Age With Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic ArthritisDrug: CP-690,550PfizerNULLCompleted2 Years17 YearsAll26Phase 1United States;Germany;Poland;Slovakia;Hungary
197EUCTR2012-003054-92-ES
(EUCTR)
28/01/201321/12/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ?-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
198EUCTR2012-003054-92-AT
(EUCTR)
24/01/201311/12/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: Ilaris
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Trade Name: ILARIS
Product Name: Ilaris
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
239United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;Sweden
199EUCTR2012-000444-10-IT
(EUCTR)
22/01/201311/01/2013A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden
200NCT01676948
(ClinicalTrials.gov)
January 201329/8/2012An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisDrug: ACZ885;Drug: CanakinumabNovartis PharmaceuticalsPRINTO/PRCSGWithdrawn2 Years20 YearsBoth0Phase 3Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
201EUCTR2012-000444-10-DE
(EUCTR)
30/11/201228/09/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
43Phase 4Sweden;Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom
202EUCTR2012-000444-10-ES
(EUCTR)
22/11/201214/09/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 15.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Mexico;Canada;Spain;Australia;Germany;Norway;Italy;United Kingdom;Sweden
203EUCTR2011-004914-40-IT
(EUCTR)
14/11/201221/09/2012A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients aged 2-18AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THEPHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 INPEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITHJUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Hungary;Mexico;Argentina;Poland;Russian Federation;Italy
204EUCTR2012-000444-10-GB
(EUCTR)
09/11/201221/08/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
43 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSweden;United Kingdom;Italy;Germany;Norway;Israel;Russian Federation;Australia;Spain;Canada;Mexico
205EUCTR2012-000444-10-SE
(EUCTR)
01/11/201204/10/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
43Phase 4Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;United Kingdom;Italy;Sweden
206NCT01455701
(ClinicalTrials.gov)
October 26, 201218/10/2011A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)Juvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompletedN/A24 MonthsAll11Phase 1United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;United Kingdom
207EUCTR2011-004914-40-PL
(EUCTR)
19/09/201216/05/2012A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 17.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy
208EUCTR2011-004915-22-DE
(EUCTR)
17/09/201211/06/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden
209EUCTR2011-004915-22-PL
(EUCTR)
14/09/201221/05/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Australia;Peru;South Africa;Bosnia and Herzegovina;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand
210NCT01694264
(ClinicalTrials.gov)
September 1, 201224/9/2012Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFaA Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa TreatmentChronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic ArthritisDrug: Entecavir;Drug: PlaceboSeoul National University HospitalKonkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro HospitalTerminated16 Years85 YearsAll43Phase 3Korea, Republic of
211EUCTR2011-004915-22-HU
(EUCTR)
03/08/201217/05/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 15.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Serbia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Germany;Italy
212EUCTR2011-004914-40-HU
(EUCTR)
03/08/201217/05/2012AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 15.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Poland;Russian Federation;Germany;Italy;Serbia;Czech Republic;Hungary;Slovakia;Mexico;Argentina
213EUCTR2011-004914-40-SK
(EUCTR)
31/07/201231/07/2012A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy
214EUCTR2011-004915-22-SK
(EUCTR)
31/07/201231/07/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;India;Australia;Peru;South Africa;Netherlands;China;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden
215EUCTR2010-023802-10-NL
(EUCTR)
07/05/201207/11/2011Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-typesof Childhood ArthritisAN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 Oligoarticular juvenile idiopathic arthritis, enthesistis related arthritis, or psoriatic arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ENBREL 25 mg/ml polvo y disolvente para solución inyectable para uso pediátrico
INN or Proposed INN: ETANERCEPT
Other descriptive name: ETANERCEPT
Trade Name: ENBREL 50 mg solución inyectable en jeringas precargadas
INN or Proposed INN: ETANERCEPT
Other descriptive name: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United StatesNULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Netherlands;Germany;Latvia;Norway
216NCT01563185
(ClinicalTrials.gov)
April 201220/3/2012Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic ArthritisA Multicenter, Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: 800 mg ibuprofen/26.6 mg famotidineHorizon Pharma Ireland, Ltd., Dublin IrelandPediatric Rheumatology Collaborative Study GroupCompleted10 Years16 YearsAll12Phase 4United States
217NCT01544114
(ClinicalTrials.gov)
April 201221/2/2012A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic Arthritis (JIA)Drug: VIMOVO 250/20;Drug: VIMOVO 375/20;Drug: VIMOVO 500/20Horizon Pharma Ireland, Ltd., Dublin IrelandNULLCompleted12 Years16 YearsAll46Phase 4United States
218NCT01550003
(ClinicalTrials.gov)
March 8, 20127/3/2012Pediatric Arthritis Study of Certolizumab PegolA Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA)Polyarticular-course Juvenile Idiopathic Arthritis (JIA)Drug: Certolizumab Pegol (CZP)UCB BIOSCIENCES GmbHPRA Health SciencesRecruiting2 Years17 YearsAll193Phase 3United States;Argentina;Brazil;Canada;Chile;Mexico;Russian Federation
219NCT01575769
(ClinicalTrials.gov)
March 201210/4/2012An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic ArthritisLong-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From Poland and Russia Who Completed the Global, Multinational Trial (WA19977).Juvenile Idiopathic ArthritisDrug: RoActemra/Actemra (tocilizumab)Hoffmann-La RocheNULLTerminated2 YearsN/AAll41Phase 3Poland;Russian Federation
220EUCTR2010-023802-10-NO
(EUCTR)
22/02/201213/02/2012Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands
221EUCTR2010-023802-10-IT
(EUCTR)
21/02/201202/04/2012Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-typesof Childhood Arthritis.AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDEDOLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Other descriptive name: NA
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Other descriptive name: NA
PFIZER INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
123Hungary;Colombia;Germany;Netherlands;Italy;Latvia;Australia;Lithuania;Russian Federation;Slovakia;Czech Republic;Mexico;Belgium;Slovenia;Spain
222NCT01673919
(ClinicalTrials.gov)
February 201223/8/2012A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core StudyLong-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)Juvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted4 YearsN/AAll7Phase 3France
223NCT01667471
(ClinicalTrials.gov)
January 201215/8/2012A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core StudyLong-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global, Multinational Trial (WA19977)Juvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted9 Years18 YearsAll6Phase 3Germany
224NCT01557452
(ClinicalTrials.gov)
December 201114/3/2012An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA)An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA) JIAJuvenile Idiopathic ArthritisDrug: GivinostatItalfarmacoParexelTerminated2 Years18 YearsBoth1N/ACzech Republic
225EUCTR2010-023802-10-BE
(EUCTR)
10/11/201109/06/2011Study Evaluation of the Long Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Czechia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway
226EUCTR2010-023802-10-LV
(EUCTR)
28/10/201106/09/2011Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Latvia;Germany;Netherlands;Norway
227EUCTR2011-001097-25-DE
(EUCTR)
19/10/201121/09/2011Tocilizumab i.v. monthly in patients with pcJIALong-term, interventional, open label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Germany who completed the global, multinational trial (WA19977) Polyarticular-course juvenile idiopathic arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: Ro-Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Pharma AGNULLNot RecruitingFemale: no
Male: no
Germany
228EUCTR2011-003341-18-CZ
(EUCTR)
14/10/201105/09/2011NAPAn Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) - - Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl- phenyl carbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride; monohydrate
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
3Czech Republic
229NCT01421069
(ClinicalTrials.gov)
October 10, 201118/8/2011Extension Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)Juvenile Idiopahtic ArthritisDrug: etanerceptPfizerNULLCompleted2 Years30 YearsAll109Phase 3Australia;Belgium;Colombia;Czechia;France;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Netherlands;Norway;Poland;Russian Federation;Serbia;Slovakia;Slovenia;Spain;Czech Republic
230EUCTR2010-023802-10-DE
(EUCTR)
29/09/201109/08/2011Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway
231EUCTR2010-023802-10-LT
(EUCTR)
16/09/201120/06/2011Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway
232EUCTR2010-023802-10-ES
(EUCTR)
15/09/201112/07/2011Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-typesof Childhood ArthritisAN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 Oligoarticular juvenile idiopathic arthritis, enthesistis related arthritis, or psoriatic arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ENBREL 25 mg/ml polvo y disolvente para solución inyectable para uso pediátrico
INN or Proposed INN: ETANERCEPT
Other descriptive name: ETANERCEPT
Trade Name: ENBREL 50 mg solución inyectable en jeringas precargadas
INN or Proposed INN: ETANERCEPT
Other descriptive name: ETANERCEPT
PFIZER, S.L.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
123Hungary;Colombia;Germany;Netherlands;Norway;France;Italy;Latvia;Australia;Lithuania;Slovakia;Russian Federation;Czech Republic;Serbia;Slovenia;Belgium;Mexico;Spain;Poland
233EUCTR2010-023802-10-CZ
(EUCTR)
08/09/201108/07/2011Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS OF THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway
234EUCTR2010-023802-10-SK
(EUCTR)
15/08/201121/06/2011Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS OF THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands
235EUCTR2010-023802-10-HU
(EUCTR)
29/07/201108/06/2011Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 14.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway
236EUCTR2010-023802-10-FR
(EUCTR)
27/07/201110/06/2011Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 14.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway
237EUCTR2010-023802-10-SI
(EUCTR)
14/07/201112/07/2011Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2 OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 14.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
123Phase 3Serbia;Slovakia;Slovenia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands
238NCT01385826
(ClinicalTrials.gov)
June 29, 201124/5/2011Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic ArthritisEvaluation of the Efficacy of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis: Randomized Double-blind Placebo-controlled TrialUveitis;Juvenile ArthritisDrug: Anti-tumor necrosis factor alpha monoclonal antibody;Drug: placeboAssistance Publique - Hôpitaux de ParisAbbottCompleted4 YearsN/AAll34Phase 2/Phase 3France
239EUCTR2010-021141-41-GB
(EUCTR)
24/06/201130/03/2011Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis. - SYCAMORERandomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis. - SYCAMORE Juvenile Idiopathic Arthritis Associated Uveitis
MedDRA version: 14.1;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders
Product Name: Adalimumab (40mg)
INN or Proposed INN: Adalimumab
Product Name: Adalimumab (20mg)
INN or Proposed INN: Adalimumab
University Hospitals Bristol NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
154 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
240EUCTR2009-015019-42-DE
(EUCTR)
10/05/201120/08/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands
241NCT01358383
(ClinicalTrials.gov)
May 201116/5/2011Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult VolunteersA Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult SubjectsJuvenile Idiopathic ArthritisDrug: naproxen;Drug: esomeprazoleAstraZenecaNULLCompleted18 Years55 YearsBoth28Phase 1United States
242EUCTR2009-015019-42-BE
(EUCTR)
04/04/201106/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany
243EUCTR2010-020423-51-DE
(EUCTR)
17/02/201127/09/2010Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy) - REMINDER-Study Active enthesitis-related arthrtitis as a category of juvenile idiopathic arthritis (ERA-JIA) as determined by International League of Associations for Rheumatology (ILAR) criteria.
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Enbrel
Product Name: ENBREL
Trade Name: Enbrel
Product Name: Enbrel
Asklepios Klinik Sankt AugustinNULLNot RecruitingFemale: yes
Male: yes
Germany
244NCT01287715
(ClinicalTrials.gov)
January 201131/1/2011Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic ArthritisWhen and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: etanerceptErasmus Medical CenterDutch Arthritis AssociationRecruiting4 Years17 YearsBoth50Phase 4Netherlands
245EUCTR2010-019094-15-BE
(EUCTR)
07/12/201020/05/2010A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentA multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Czech Republic;Slovenia;Spain;Belgium;Italy
246NCT01230827
(ClinicalTrials.gov)
December 201028/10/2010A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard TherapyJuvenile Idiopathic ArthritisDrug: CNTO 148 (Golimumab);Drug: Placebo;Drug: MethotrexateJanssen Research & Development, LLCSchering-PloughTerminated2 Years18 YearsAll173Phase 3United States;Austria;Belgium;Brazil;Canada;Finland;Germany;Lithuania;Mexico;Netherlands;Poland;Russian Federation;Argentina
247EUCTR2009-015019-42-FI
(EUCTR)
17/11/201027/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands
248EUCTR2009-015019-42-LT
(EUCTR)
02/11/201017/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
249EUCTR2009-015019-42-AT
(EUCTR)
05/10/201001/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
250NCT01261624
(ClinicalTrials.gov)
October 201015/12/2010Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic ArthritisA Multicenter, Open Label, Dose Finding Study to Evaluate Efficacy and Safety of Givinostat Administered in Two Different Doses in Patients With Poly JIA Not Adequately Responding to the Standard Treatment.Polyarticular Course Juvenile Idiopathic ArthritisDrug: GivinostatItalfarmacoNULLTerminated2 Years17 YearsAll16Phase 2Belgium;Czech Republic;Italy;Romania;Serbia;Slovenia;Spain
251EUCTR2010-019094-15-ES
(EUCTR)
06/09/201026/05/2010Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentEstudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Artritis Idiopática Juvenil de evolución poliarticular (AIJ poli) / Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
252EUCTR2010-019094-15-SI
(EUCTR)
17/08/201022/06/2010A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentA multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
253EUCTR2010-019094-15-IT
(EUCTR)
12/07/201027/05/2010A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36 polyarticular course Juvenile Idiopathic Arthritis in ethe following forms: - RF positive and negative polyarthritis - systemic arthritis without systemic features - extended oligoarthritis
MedDRA version: 12.1;Level: LLT;Classification code 10036036;Term: Polyarticular JCA
Product Code: Givinostat
INN or Proposed INN: Givinostat
ITALFARMACONULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
254EUCTR2010-019094-15-CZ
(EUCTR)
01/07/201017/05/2010A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentA multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
255EUCTR2008-005476-27-GR
(EUCTR)
15/06/201017/12/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
256EUCTR2008-008008-42-GR
(EUCTR)
15/06/201004/12/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
257NCT00637780
(ClinicalTrials.gov)
June 201011/3/2008Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic ArthritisAn Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic ArthritisArthritis, Juvenile RheumatoidDrug: SulfasalazinePfizerNULLTerminated6 Years17 YearsAll2Phase 4United States;Mexico;Canada
258EUCTR2009-013091-40-CZ
(EUCTR)
25/05/201023/02/2010Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
30France;Czech Republic;Germany;Sweden
259EUCTR2009-012520-84-NL
(EUCTR)
19/05/201012/10/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Netherlands;Germany;Latvia;Sweden
260EUCTR2009-013091-40-DE
(EUCTR)
17/05/201011/12/2009Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
30France;Czech Republic;Germany;Sweden
261EUCTR2009-013091-40-DK
(EUCTR)
05/05/201008/03/2010Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Czech Republic;Denmark;Germany;Sweden
262EUCTR2008-005479-82-GR
(EUCTR)
20/04/201004/12/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
263EUCTR2009-013091-40-SE
(EUCTR)
12/04/201004/02/2010Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
30France;Czech Republic;Germany;Sweden
264NCT01151644
(ClinicalTrials.gov)
April 201025/6/2010Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloActive, not recruitingN/AN/ABoth5000Phase 4Brazil
265EUCTR2009-012520-84-GR
(EUCTR)
22/03/201020/10/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Slovenia;Slovakia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden
266EUCTR2008-005476-27-GB
(EUCTR)
08/03/201011/09/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
267EUCTR2009-013091-40-SK
(EUCTR)
03/03/201004/02/2010Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Czech Republic;Slovakia;Denmark;Germany;Sweden
268NCT04200833
(ClinicalTrials.gov)
March 1, 20106/8/2019Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing AdalimumabGolimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing AdalimumabJIA Associated UveitisDrug: GolimumabMedical University of GrazNULLCompletedN/AN/AAll10NULL
269EUCTR2009-013091-40-FR
(EUCTR)
22/02/201010/12/2009Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Denmark;Germany;Sweden
270EUCTR2009-011593-15-NL
(EUCTR)
09/02/201030/09/2009A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritisA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis polyarticular-course juvenile idiopathic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: RoActemra
Product Code: Ro 487-7533/F01
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy
271EUCTR2009-012520-84-CZ
(EUCTR)
08/02/201031/07/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.0;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Latvia;Sweden
272EUCTR2009-012520-84-DK
(EUCTR)
08/02/201010/11/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., A Pfizer Company, Philadelphia, PA-19101, USANULLNot RecruitingFemale: yes
Male: yes
100Hungary;Germany;Netherlands;France;Italy;Latvia;Sweden;Lithuania;Czech Republic;Denmark;Belgium;Slovenia;Spain;Greece
273EUCTR2008-008008-42-AT
(EUCTR)
28/01/201030/12/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
304United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden
274EUCTR2009-012520-84-IT
(EUCTR)
28/01/201028/01/2010A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - NDA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - ND Extended Oligoarticular Juvenile Idiopathic Arthritis (JIA) Enthesitis-Related Arthritis (ERA) Psoriatic Arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246
Trade Name: ENBREL*BB SC 4FL 25MG 1ML+4SIR
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden
275EUCTR2009-012520-84-LT
(EUCTR)
30/12/200901/10/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.1;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Latvia;Netherlands;Norway;Sweden
276EUCTR2008-005479-82-AT
(EUCTR)
17/12/200902/12/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
277EUCTR2008-008008-42-GB
(EUCTR)
16/12/200911/09/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
304United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Netherlands;Norway;Germany;Sweden
278EUCTR2008-005479-82-GB
(EUCTR)
16/12/200911/09/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
279EUCTR2009-012520-84-DE
(EUCTR)
04/12/200907/07/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.1;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Latvia;Sweden
280EUCTR2009-012520-84-BE
(EUCTR)
03/12/200922/07/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.1;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNot RecruitingFemale: yes
Male: yes
100Phase 3Slovakia;Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Latvia;Sweden
281EUCTR2009-012520-84-LV
(EUCTR)
01/12/200916/10/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.0;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Latvia;Germany;Netherlands;Norway;Sweden
282EUCTR2009-012520-84-ES
(EUCTR)
30/11/200921/08/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis?ESTUDIO ABIERTO, DE DOS PARTES, PARA EVALUAR EL BENEFICIO CLÍNICO Y LA SEGURIDAD A LARGO PLAZO DE ETANERCEPT EN NIÑOS Y ADOLESCENTES CON ARTRITIS IDIOPÁTICA JUVENIL OLIGOARTICULAR EXTENDIDA, ARTRITIS ASOCIADA A ENTESITIS O ARTRITIS PSORIÁSICA? .A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis?ESTUDIO ABIERTO, DE DOS PARTES, PARA EVALUAR EL BENEFICIO CLÍNICO Y LA SEGURIDAD A LARGO PLAZO DE ETANERCEPT EN NIÑOS Y ADOLESCENTES CON ARTRITIS IDIOPÁTICA JUVENIL OLIGOARTICULAR EXTENDIDA, ARTRITIS ASOCIADA A ENTESITIS O ARTRITIS PSORIÁSICA? . Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)Artritis Idiopática Juvenil Oligoarticular Extendida, Artritis Asociada a Entesitis o Artritis Psoriásica.
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Slovenia;Slovakia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden
283NCT00988221
(ClinicalTrials.gov)
November 30, 20091/10/2009A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic ArthritisA 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: Tocilizumab;Drug: PlaceboHoffmann-La RocheNULLCompleted2 Years17 YearsAll188Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Netherlands
284EUCTR2008-005479-82-DE
(EUCTR)
24/11/200917/04/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
285EUCTR2008-005476-27-DE
(EUCTR)
24/11/200917/04/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
286EUCTR2008-008008-42-DE
(EUCTR)
24/11/200917/04/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Denmark;Peru;Netherlands;Germany;Norway;Sweden
287EUCTR2009-011593-15-FR
(EUCTR)
12/11/200904/12/2009A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritisA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis polyarticular-course juvenile idiopathic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: RoActemra
Product Code: Ro 487-7533/F01
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy
288EUCTR2008-008008-42-DK
(EUCTR)
10/11/200930/09/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88Hungary;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden
289EUCTR2008-008008-42-NL
(EUCTR)
05/11/200925/05/2009research with children with severe reumaAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Germany;Netherlands;Sweden
290EUCTR2008-005479-82-DK
(EUCTR)
28/10/200930/09/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden
291EUCTR2008-005476-27-DK
(EUCTR)
28/10/200928/09/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Sweden
292EUCTR2009-011593-15-ES
(EUCTR)
27/10/200929/07/2009Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritisEnsayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis Artritis idiopática juvenil activa de curso poliarticular/Polyarticular-course juvenile idiopathic arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185Phase 3France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
293EUCTR2009-011593-15-BE
(EUCTR)
19/10/200923/09/2009A two year study to evaluate the effect of tocilizumab in children who have arthritis in several jointsA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH Polyarticular-course juvenile idiopathic arthritis
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185Phase 3Canada;Argentina;Belgium;Poland;Brazil;Peru;Australia;Netherlands;Germany;Mexico;United States;Spain;Russian Federation;Italy;United Kingdom;France
294EUCTR2009-012520-84-SI
(EUCTR)
02/10/200919/08/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.0;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Latvia;Sweden
295EUCTR2009-012520-84-SE
(EUCTR)
23/09/200927/08/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., A Pfizer Company, Philadelphia, PA-19101, USANULLNot RecruitingFemale: yes
Male: yes
100Hungary;Germany;Netherlands;France;Italy;Latvia;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Denmark;Spain;Greece
296EUCTR2009-012520-84-FR
(EUCTR)
21/09/200906/08/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Hungary;Germany;Netherlands;France;Italy;Latvia;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Denmark;Spain;Greece
297EUCTR2009-011593-15-IT
(EUCTR)
11/09/200928/07/2009A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - NDA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - ND Polyarticular-course JIA (pcJIA) consisting of RF-positive, RF-negative, and extended oligoarticular subsets.
MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: RoActemra
Trade Name: RoActemra
Trade Name: RoActemra
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185France;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
298EUCTR2009-012520-84-SK
(EUCTR)
09/09/200916/09/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USANULLNot RecruitingFemale: yes
Male: yes
100Phase 3Slovakia;Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden
299EUCTR2009-011593-15-DE
(EUCTR)
08/09/200920/07/2009A two year study to evaluate the effect of tocilizumab in children who have arthritis in several jointsA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH Polyarticular-course juvenile idiopathic arthritis
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic 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
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;Peru;Germany;Netherlands
300NCT00891046
(ClinicalTrials.gov)
September 200929/4/2009An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without FeverSystemic Juvenile Idiopathic ArthritisDrug: CanakinumabNovartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompleted2 Years19 YearsAll270Phase 3United States;Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Peru;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;Denmark;Norway;South Africa
301NCT00962741
(ClinicalTrials.gov)
September 200913/8/2009Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic ArthritisArthritis, Juvenile IdiopathicDrug: EtanerceptPfizerNULLCompleted2 Years17 YearsAll127Phase 3Australia;Belgium;Colombia;Czech Republic;France;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Netherlands;Norway;Poland;Russian Federation;Serbia;Slovakia;Slovenia;Spain;Argentina;Brazil;Denmark;Greece;Sweden;Taiwan
302NCT00807846
(ClinicalTrials.gov)
September 200910/12/2008A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric SubjectsA Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.Arthritis, Juvenile RheumatoidDrug: Celecoxib;Drug: NaproxenPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted2 Years17 YearsAll201Phase 4United States;Chile;Costa Rica;Peru;Philippines;Russian Federation;Serbia;South Africa;Switzerland;Ukraine
303EUCTR2009-011593-15-GB
(EUCTR)
20/08/200906/07/2009 A two year study to evaluate the effect of tocilizumab in children who have arthritis in several jointsA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH Polyarticular-course juvenile idiopathic arthritis
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
185 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany
304EUCTR2009-012520-84-HU
(EUCTR)
19/08/200906/07/2009A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 9.1;Level: LLT;Classification code 10003246;Term: Arthritis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
100Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden
305EUCTR2008-005479-82-IT
(EUCTR)
20/07/200905/08/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: ILARIS
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
306EUCTR2008-005479-82-SE
(EUCTR)
16/07/200916/06/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
307EUCTR2008-008008-42-SE
(EUCTR)
16/07/200916/06/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
285United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Swaziland;Canada;Argentina;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden
308EUCTR2008-005476-27-SE
(EUCTR)
16/07/200918/06/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
309NCT00886769
(ClinicalTrials.gov)
July 200922/4/2009Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic ManifestationsSystemic Juvenile Idiopathic ArthritisDrug: Canakinumab;Drug: PlaceboNovartis PharmaceuticalsInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group;Southwest Pediatric Nephrology Study GroupTerminated2 Years19 YearsAll84Phase 3United States;Argentina;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Norway;Peru;Poland;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom
310NCT00889863
(ClinicalTrials.gov)
July 200921/4/2009Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic ManifestationsSystemic Juvenile Idiopathic Arthritis With Active FlareDrug: canakinumab;Drug: placeboNovartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompleted2 Years19 YearsAll177Phase 3United States;Argentina;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Peru;Poland;South Africa;Spain;Sweden;Switzerland;Turkey
311NCT01145352
(ClinicalTrials.gov)
July 20099/6/2010Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]Enbrel-JIA Use Results Survey [All-Case Surveillance]Juvenile Idiopathic ArthritisDrug: Etanercept (genetical recombination)PfizerNULLCompleted5 Years16 YearsAll113N/AJapan
312EUCTR2008-003280-40-NL
(EUCTR)
30/06/200923/02/2009Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed childrenResponse to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed children The effectiveness of Ambirix will be investigated in 2 groups:1) children with hiv-infection, with CD4 counts > 15%2) children with a rheumatic disease for which immune-suppressive medication is used.
MedDRA version: 9.1;Level: LLT;Classification code 10002725;Term: Anti-HIV positive
MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: Ambirix
Trade Name: Ambirix
Public Health Service AmsterdamNULLNot RecruitingFemale: yes
Male: yes
Netherlands
313EUCTR2008-008008-42-IT
(EUCTR)
22/06/200905/08/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - NDAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: canakinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
314EUCTR2008-005476-27-IT
(EUCTR)
22/06/200905/08/2009A randomized, double-blind, placebo controlled, singledose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - NDA randomized, double-blind, placebo controlled, singledose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: canakinumab
Product Code: ACZ885G
INN or Proposed INN: ILARIS
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
315EUCTR2008-008008-42-ES
(EUCTR)
12/06/200901/04/2009Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1 Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
316EUCTR2008-005479-82-ES
(EUCTR)
12/06/200905/03/2009Estudio doble ciego, randomizado, controlado con placebo, con diseño de retirada en la prevención de brotes con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301 Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas.
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
317EUCTR2008-005479-82-BE
(EUCTR)
04/06/200914/04/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Phase 3France;Hungary;Greece;Spain;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
318EUCTR2008-008008-42-BE
(EUCTR)
04/06/200909/04/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Ilaris
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Peru;Netherlands;Germany;Sweden
319EUCTR2008-005476-27-BE
(EUCTR)
04/06/200927/04/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
320EUCTR2008-005476-27-ES
(EUCTR)
14/05/200903/03/2009Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305 Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas.
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
122Phase 3France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
321EUCTR2008-005479-82-FR
(EUCTR)
07/05/200919/03/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestationsA randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Phase 3France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
322EUCTR2008-008008-42-FR
(EUCTR)
07/05/200919/03/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestationsAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
323EUCTR2008-005476-27-FR
(EUCTR)
07/05/200919/03/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestationsA randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Phase 3France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
324EUCTR2008-005479-82-HU
(EUCTR)
05/05/200906/04/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
325EUCTR2008-008008-42-HU
(EUCTR)
05/05/200907/04/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
304United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Netherlands;Germany;Sweden
326EUCTR2008-005476-27-HU
(EUCTR)
04/05/200907/04/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
327NCT00688545
(ClinicalTrials.gov)
April 200929/5/2008Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic ArthritisSINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDsArthritis, Juvenile RheumatoidDrug: Celecoxib;Drug: nsNSAIDsPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLTerminated2 Years17 YearsAll275United States
328NCT00775437
(ClinicalTrials.gov)
March 200917/10/2008Active Juvenile Idiopathic Arthritis (JIA) Compassionate UseCompassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg With Active Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic ArthritisDrug: AdalimumabAbbVie (prior sponsor, Abbott)NULLCompleted2 Years4 YearsAll32Phase 3Czech Republic;Denmark;France;Germany;Puerto Rico;Slovakia;Sweden;United States
329NCT00868751
(ClinicalTrials.gov)
March 200924/3/2009Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic ArthritisSingle Patient Use of Tocilizumab for Treatment of Steroid Dependent, Active Systemic Onset Juvenile Idiopathic ArthritisArthritis, Juvenile Rheumatoid;Still's Disease, Juvenile OnsetBiological: tocilizumabTufts Medical CenterHoffmann-La RocheTerminated2 Years16 YearsAll1N/AUnited States
330EUCTR2008-008169-36-NL
(EUCTR)
17/02/200929/12/2008Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV studyImmune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study Juvenile Idiopathic ArthritisSystemic lupus erythematosus childhood dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd
MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis
MedDRA version: 9.1;Classification code 10008521;Term: Childhood dermatomyositis
Trade Name: Cervarix suspensie voor injectie
Product Name: not applicable
Product Code: not applicable
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: no
Netherlands
331NCT00862758
(ClinicalTrials.gov)
February 200916/3/2009Request for Single Patient IND for Compassionate/Emergency Use of TocilizumabEmergency IND for Provision of TocilizumabJuvenile Idiopathic ArthritisDrug: TocilizumabUniversity of OklahomaHoffmann-La RocheNo longer available11 Years12 YearsMaleN/AUnited States
332EUCTR2006-006812-31-DE
(EUCTR)
03/12/200825/06/2008Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance studyMulticenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effectsOther descriptive name: METHOTREXATE DISODIUM
Trade Name: metoject
University of MunsterNULLNot RecruitingFemale: yes
Male: yes
120Phase 4Netherlands;Germany
333EUCTR2007-000872-18-NL
(EUCTR)
01/12/200806/03/2008A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumabA 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Tocilizumab Roche
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: MRA, Actemra
F. Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
334NCT00534495
(ClinicalTrials.gov)
November 200824/9/2007Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young AdultsRandomized Placebo Phase Study of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT)Juvenile Idiopathic ArthritisBiological: RilonaceptMontefiore Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Months19 YearsAll71Phase 2United States
335EUCTR2008-006741-70-IT
(EUCTR)
16/10/200817/03/2009Comparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial - NDComparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial - ND juvenile idiopatic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: METHOTREXATE*25CPR 2,5MG
INN or Proposed INN: Methotrexate
ISTITUTO GIANNINA GASLININULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
336EUCTR2007-000872-18-CZ
(EUCTR)
16/10/200826/02/2008The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
337EUCTR2007-000872-18-GB
(EUCTR)
03/10/200826/08/2009The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
108 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
338JPRN-UMIN000001457
2008/10/0128/10/2008The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial Adult Still's disease and systemic juvenile idiopathic arthritisTocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weightDivision of Rheumatology & Clinical Immunology, Jichi Medical UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female10Not selectedJapan
339EUCTR2007-000872-18-GR
(EUCTR)
09/09/200821/03/2008A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumabA 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Tocilizumab Roche
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab
Other descriptive name: MRA (Actemra)
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108Phase 3Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Norway;Germany;United Kingdom;Italy;Sweden
340EUCTR2007-000872-18-DE
(EUCTR)
11/07/200814/02/2008The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 14.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Norway;Sweden
341NCT00783510
(ClinicalTrials.gov)
July 11, 200828/10/2008Juvenile Idiopathic Arthritis (JIA) RegistryA Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) - STRIVEJuvenile Idiopathic Arthritis;JIABiological: adalimumab;Drug: MethotrexateAbbVieNULLActive, not recruiting2 Years17 YearsAll833United States;Australia;Austria;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Netherlands;Norway;Portugal;Puerto Rico;Slovakia;Spain;Sweden;Czech Republic
342JPRN-UMIN000001250
2008/07/0116/07/2008Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial Adult Still's disease or systemic juvenile idiopathic arthritisTocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks.Division of Rheumatology & Clinical Immunology, Jichi Medical UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female10Not selectedJapan
343EUCTR2007-000872-18-DK
(EUCTR)
27/06/200805/03/2008A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumabA 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Tocilizumab
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Other descriptive name: Actemra
F. Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
344EUCTR2007-000872-18-SK
(EUCTR)
09/06/200809/04/2008A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumabA 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
345EUCTR2007-000872-18-ES
(EUCTR)
23/05/200826/02/2008Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDEREstudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER Artritis idiopatica juvenil sistémica (sJIA)Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Tocilizumab Roche
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: Actemra
F. Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
346EUCTR2007-000872-18-IT
(EUCTR)
12/05/200823/03/2009A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - NDA 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: ACTEMRA
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab
ROCHENULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
347NCT00642460
(ClinicalTrials.gov)
May 200819/3/2008A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of TocilizumabJuvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroidsHoffmann-La RocheNULLCompleted2 Years17 YearsAll112Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France
348NCT00731965
(ClinicalTrials.gov)
May 20086/8/2008Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic ArthritisMulticenter Randomized Clinical Trial in Patients With Juvenile Idiopathic Arthritis: Safety and Efficacy of Vaccination With Live Attenuated Measles, Mumps, Rubella VaccineArthritis, Juvenile RheumatoidBiological: Measles, Mumps, Rubella vaccinationN.M. WulffraatUniversity Medical Centre Groningen;VU University Medical Center;Maastricht University Medical Center;Erasmus Medical CenterCompleted4 Years9 YearsBoth140Phase 4Netherlands
349EUCTR2007-000872-18-BE
(EUCTR)
15/04/200829/01/2008The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
350EUCTR2007-000872-18-SE
(EUCTR)
07/04/200805/02/2008A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumabA 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Tocilizumab Roche
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: MRA, Actemra
F. Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
351EUCTR2007-001861-14-NL
(EUCTR)
07/02/200829/02/2008Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine - safety and efficacy of MMR vaccination in JIA patientsMulticenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine - safety and efficacy of MMR vaccination in JIA patients Juvenile Idiopathic Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Bof-, Mazelen-, Rubellavaccin, poeder voor injectievloeistof
Trade Name: M-M-RVAXPRO
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
352NCT02196480
(ClinicalTrials.gov)
January 200816/7/201423-valent Polysaccharide Pneumococcal Vaccine in Juvenile Idiopathic Arthritis Patients Under Anti-TNF TherapyShort and Long-term Immunogenicity and Safety Following the 23-valent Polysaccharide Pneumococcal Vaccine in Juvenile Idiopathic Arthritis Patients Under Anti-TNF TherapyJuvenile Idiopathic ArthritisBiological: anti-TNFUniversity of Sao PauloNULLCompleted5 Years18 YearsBoth27Phase 4Brazil
353EUCTR2007-000255-34-DE
(EUCTR)
05/06/200709/05/2007a multicentre, open, uncontrolled phase IIIb study to evaluate the efficacy and safety of Etanercept 0,8 mg/kg body weight (bw) given once weekly to patients with polyarticular-course juvenile idiopathic arthritis (JIA) for 12 weeks - Etanercept 0,8 mg/kg bw (Enbrel®) once weekly for patients with JIAa multicentre, open, uncontrolled phase IIIb study to evaluate the efficacy and safety of Etanercept 0,8 mg/kg body weight (bw) given once weekly to patients with polyarticular-course juvenile idiopathic arthritis (JIA) for 12 weeks - Etanercept 0,8 mg/kg bw (Enbrel®) once weekly for patients with JIA children with juvenile idiopathic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Asklepios-Klinik Sankt AugustinNULLNot RecruitingFemale: yes
Male: yes
20Phase 3Germany
354EUCTR2006-006812-31-NL
(EUCTR)
04/06/200727/06/2007Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance studyMulticenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effectsOther descriptive name: METHOTREXATE DISODIUM
Trade Name: metoject
university medical centre utrechtNULLNot RecruitingFemale: yes
Male: yes
120Phase 4Germany;Netherlands
355NCT02263703
(ClinicalTrials.gov)
May 20073/10/2014Immunogenicity of HPV Vaccine in Immunosuppressed ChildrenImmunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV VaccineAutoimmune Disease;Juvenile Idiopathic Arthritis;Inflammatory Bowel Disease;Evidence of Liver Transplantation;Kidney Transplant Infection;Bone Marrow Transplant InfectionBiological: Quadrivalent HPV vaccineThe University of New South WalesSydney Children's Hospitals Network;Women's and Children's Hospital, AustraliaCompletedN/A18 YearsAll55Phase 3Australia
356NCT00443430
(ClinicalTrials.gov)
May 20072/3/2007Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic ArthritisTrial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid ArthritisDrug: methotrexate;Drug: methotrexate - etanercept - prednisolone armSeattle Children's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);AmgenCompleted2 Years17 YearsAll85Phase 4United States
357EUCTR2006-001834-42-GB
(EUCTR)
27/04/200714/10/2010A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885A2203A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885A2203 Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 8.1;Level: PT;Classification code 10059177;Term: Juvenile arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: ACZ885 Drug Substance
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
26 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Italy;United Kingdom
358EUCTR2006-001834-42-FR
(EUCTR)
17/04/200705/10/2006A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 8.1;Level: PT;Classification code 10059177;Term: Juvenile arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: ACZ885 Drug Substance
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
26France;United Kingdom;Italy
359NCT00426218
(ClinicalTrials.gov)
December 200623/1/2007Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Arthritis, Juvenile RheumatoidDrug: ACZ885NovartisNULLCompleted4 Years20 YearsBoth26Phase 1/Phase 2Italy
360EUCTR2006-001834-42-IT
(EUCTR)
13/10/200609/01/2007A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203 Sistemic Juvenile Idiopathic Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Code: ACZ885
Product Code: ACZ885
Product Code: ACZ885
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
United Kingdom;France;Italy
361EUCTR2006-000089-35-IT
(EUCTR)
17/08/200630/08/2006Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - NDPhase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND systemic onset juvenile idiopathic arthritis
Level: PTClassification code 10059177
Product Code: ITF2357
Product Code: ITF2357
Product Code: ITF2357
Product Code: ITF2357
Product Code: ITF2357
Product Code: ITF2357
ITALFARMACONULLNot RecruitingFemale: yes
Male: yes
16Phase 2Italy
362NCT00570661
(ClinicalTrials.gov)
August 200610/12/2007Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA)Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA)Active Systemic;Onset Juvenile Idiopathic ArthritisDrug: ITF2357ItalfarmacoNULLCompleted2 Years25 YearsBoth17Phase 2Serbia;Former Serbia and Montenegro
363NCT00415935
(ClinicalTrials.gov)
July 200622/12/2006PRINTO (the Paediatric Rheumatology International Trials Organisation)Juvenile Idiopathic ArthritisDrug: methotrexateInstitute of Child HealthNULLRecruitingN/A16 YearsBothN/AUnited Kingdom
364NCT00339157
(ClinicalTrials.gov)
June 200616/6/2006Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITISANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)Systemic-Onset Juvenile Idiopathic ArthritisDrug: Anakinra;Biological: Pneumo23Institut National de la Santé Et de la Recherche Médicale, FranceNULLCompleted2 Years20 YearsBoth24Phase 2/Phase 3France
365EUCTR2005-003129-23-GB
(EUCTR)
18/04/200624/02/2006To prevent and treat osteoporosis in children with rhuematic diseases taking steroidsPrevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) Vasculitis;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Risedronate Sodium
Product Code: 35mg
Other descriptive name: RISEDRONATE SODIUM
Product Name: Risedronate Sodium
Product Code: 5mg
Other descriptive name: RISEDRONATE SODIUM
Trade Name: One-Alpha drops
Product Name: One Alpha Drops
Product Code: alfacalcidol 2 micrograms/ml
INN or Proposed INN: ALFACALCIDOL
Other descriptive name: drops
Belfast Health and Social Care Trust, Musgrave Park HospitalNULLNot Recruiting Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
366NCT01803321
(ClinicalTrials.gov)
November 200528/2/2013Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisDrug: rilonacept (IL-1 Trap);Other: PlaceboRegeneron PharmaceuticalsNULLCompleted4 Years20 YearsBoth24Phase 1United States
367EUCTR2005-004008-36-IT
(EUCTR)
27/10/200530/01/2012Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritisEfficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
INN or Proposed INN: Anakinra
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Italy
368EUCTR2005-001086-34-ES
(EUCTR)
21/10/200520/06/2005A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patiebts with juvenile idiopathic arthritis in clinical remission.Ensayo aleatorizado de retirada de Metotrexate a los 6 meses versus a los 12 meses, en pacientes con Artritis Idiopática Juvenil (AIJ) en remisión clínica - MTX withdrawal studyA randomised trial of 6 months versus 12 months withdrawal of methotrexate in patiebts with juvenile idiopathic arthritis in clinical remission.Ensayo aleatorizado de retirada de Metotrexate a los 6 meses versus a los 12 meses, en pacientes con Artritis Idiopática Juvenil (AIJ) en remisión clínica - MTX withdrawal study The present study was designed for the follow up of two groups of patients with JIA, in whom remission was achieved using MTX. In group 1 treatment with MTX will be discontinued as early as 6 months after documentation of remission on medication. In group 2 treatment with MTX will be discontinued later than 12 mpnths after documentation of remission on medication.Trade Name: Metotrexato
Product Name: Methotrexate
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: L01BA01
Istituto Giannina Gaslini-PRINTONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Denmark;Spain;Italy
369EUCTR2005-001086-34-DK
(EUCTR)
21/09/200519/08/2005A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clincal remission - MTX withdrawal studyA randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clincal remission - MTX withdrawal study The present study was designed for the follow up of two groups of patients with JIA, in whom remission was achieved using MTX. In group 1 treatment with MTX will be discontinued as early as 6 months after documentation of remission on medication. In group 2 treatment with MTX will be discontinued later than 12 months after documentation of remission on medicationProduct Name: Methotrexate
Product Code: L01BA01
Product Name: Methotrexate
Product Code: L01BA01
ISTITUTO GIANNINA GASLINI-PRINTONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Denmark;Spain;Italy
370NCT00130637
(ClinicalTrials.gov)
August 200512/8/2005Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated UveitisTreatment of Active Anterior Uveitis Associated With JIA, Using Humanized Anti-Tac (HAT, Daclizumab)Anterior Uveitis;Arthritis, Juvenile Idiopathic;Iritis;ImmunosuppressionDrug: DaclizumabNational Eye Institute (NEI)The EMMES CorporationCompleted6 Years18 YearsAll6Phase 2United States
371EUCTR2005-001086-34-IT
(EUCTR)
13/06/200501/07/2005A randomised Phase III trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clinical remissionA randomised Phase III trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clinical remission juvenile idiopathic arthritis
MedDRA version: 6.1;Level: PT;Classification code 10059177
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Phase 3Denmark;Spain;Italy
372NCT00144625
(ClinicalTrials.gov)
February 20052/9/2005Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JPPolyarticular Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted2 Years19 YearsBoth19Phase 3NULL
373EUCTR2004-004153-25-GB
(EUCTR)
10/12/200417/02/2005Effect of recombinant growth hormone on growth and chondrocyte dynamics in children with juvenile idiopathic arthritis (JIA) and growth failure. - rhGH in JIAEffect of recombinant growth hormone on growth and chondrocyte dynamics in children with juvenile idiopathic arthritis (JIA) and growth failure. - rhGH in JIA Growth retardation secondary to juvenile idiopathic arthritisTrade Name: Norditropin SimpleXx 5mg/1.5ml
Product Name: Norditropin SimpleXx
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone
Royal Hospital For Sick Children, Yorkhill DivisionNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
374NCT00144664
(ClinicalTrials.gov)
November 20042/9/2005Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIASystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted2 Years19 YearsBoth19Phase 3NULL
375NCT00144612
(ClinicalTrials.gov)
July 20042/9/2005Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JPSystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted2 Years19 YearsBoth60Phase 3NULL
376NCT00144599
(ClinicalTrials.gov)
May 20042/9/2005Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIASystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab);Drug: placeboChugai PharmaceuticalNULLCompleted2 Years19 YearsBoth56Phase 3NULL
377NCT01015547
(ClinicalTrials.gov)
May 200317/11/2009Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic ArthritisComparison of Anti-TNF Therapy Plus Methotrexate, Combination Therapy of DMARDs, and Methotrexate Alone in Very Early Polyarticular Juvenile Idiopathic Arthritis. A National Randomized Multicenter Clinical Trial.Juvenile Idiopathic ArthritisDrug: Infliximab plus methotrexate;Drug: Combination of DMARDs;Drug: Methotrexate aloneHelsinki University Central HospitalFoundation for Paediatric Research, Finland;Päivikki and Sakari Sohlberg Foundation, Finland;Rheumatism Foundation Hospital;Scandinavian Rheumatology Research Foundation;Paijat-Hame Hospital DistrictCompleted4 Years15 YearsBoth60Phase 3Finland
378NCT00195377
(ClinicalTrials.gov)
April 200313/9/2005Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in SpainEvaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter StudyArthritis, Psoriatic;Arthritis, RheumatoidDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted4 YearsN/ABoth1000Spain
379NCT00048542
(ClinicalTrials.gov)
September 20021/11/2002Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic ArthritisArthritis, Juvenile IdiopathicBiological: Double-Blind Adalimumab/Placebo + MTX;Biological: Double-Blind Adalimumab/Placebo;Drug: OLE BSA Adalimumab +/- MTX;Drug: OLE FD Adalimumab +/- MTXAbbottNULLCompleted4 Years17 YearsAll171Phase 3United States;Belgium;Czech Republic;France;Germany;Italy;Slovakia;Spain
380NCT02784808
(ClinicalTrials.gov)
January 200025/5/2016Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)Juvenile Idiopathic ArthritisDrug: Biological DMARDs;Drug: Non-Biologic DMARDsHoffmann-La RocheNULLCompletedN/A18 YearsBoth4557N/ANULL
381NCT00420251
(ClinicalTrials.gov)
March 19969/1/2007Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic ArthritisRecombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone DevelopmentJuvenile Idiopathic Arthritis;Still Disease, Juvenile-OnsetDrug: GenotropinLudwig-Maximilians - University of MunichPfizerCompleted4 Years14 YearsBoth50Phase 3Germany
382NCT00404482
(ClinicalTrials.gov)
January 199127/11/2006Cyclosporine A in the Treatment of Juvenile Idiopathic Arthritis (JIA) Associated Chronic Anterior UveitisEfficacy and Adverse Effects of Cyclosporine A in the Treatment of Chronic Anterior Uveitis in Patients With Juvenile Idiopathic ArthritisUveitis;Juvenile Idiopathic ArthritisDrug: Cyclosporine ASt. Franziskus HospitalNULLCompletedN/A16 YearsBoth60N/AGermany
383EUCTR2021-001577-24-FR
(EUCTR)
27/08/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE).
MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
384EUCTR2011-004915-22-NL
(EUCTR)
05/02/2021A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNAFemale: yes
Male: yes
340Phase 2;Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany;Netherlands;China
385EUCTR2017-002018-29-BE
(EUCTR)
07/10/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);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
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLNAFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden
386EUCTR2009-013091-40-Outside-EU/EEA
(EUCTR)
07/02/2012Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNAFemale: yes
Male: yes
30NULL
387EUCTR2009-012520-84-Outside-EU/EEA
(EUCTR)
30/01/2012Study Evaluating Etanercept in 3 Subtypes of Childhood ArthritisA 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA)
MedDRA version: 14.1;Level: PT;Classification code 10003246;Term: Arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USANULLNAFemale: yes
Male: yes
100Australia;Colombia;Mexico;Russian Federation;Serbia
388EUCTR2008-008008-42-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIAAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis PharmaServices AGNULLNAFemale: yes
Male: yes
200Peru;Russian Federation;South Africa;Switzerland;Turkey;United States;Argentina;Brazil;Canada;Israel
389EUCTR2015-003999-79-Outside-EU/EEA
(EUCTR)
08/04/2016An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase Juvenile idiopathic arthritis
MedDRA version: 18.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: SARILUMAB
sanofi-aventis recherche & développementNULLNAFemale: yes
Male: yes
36Spain;United Kingdom;United States;Argentina;Canada;Chile;Czech Republic;Estonia;Finland;France;Germany;Italy;Mexico;Netherlands;Poland;Russian Federation
390EUCTR2008-005479-82-NO
(EUCTR)
12/03/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
214Phase 3France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
391JPRN-JapicCTI-050017
02/09/2005Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA) sJIAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion
Chugai Pharmaceutical Co., Ltd.NULL219Phase 3NULL
392EUCTR2012-003490-26-Outside-EU/EEA
(EUCTR)
22/08/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
48Phase 1Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico
393EUCTR2018-000681-10-NL
(EUCTR)
07/01/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Italy
394EUCTR2021-001577-24-IT
(EUCTR)
16/09/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE).
MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: [NI-0501]
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: [NI-0501]
INN or Proposed INN: Emapalumab
Product Name: Profilassi per Herpes Zoster
Product Code: [Profilassi per Herpes Zoster]
INN or Proposed INN: Antivirale ad uso diretto
Swedish Orphan Biovitrum AGNULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
395EUCTR2014-004105-32-Outside-EU/EEA
(EUCTR)
01/04/2015Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With Chronic Juvenile Arthritis (CJA) Treated by Corticosteroid TherapyPrevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor (Genotonorm) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-Term Corticosteroid Therapy. Extension of the Study Beyond Three Years. Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Pfizer IncNULLNAFemale: yes
Male: yes
21France
396EUCTR2014-004104-30-Outside-EU/EEA
(EUCTR)
01/04/2015Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and SafetyTreatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Pharmacia & Upjohn S.A.NULLNAFemale: yes
Male: yes
30France
397EUCTR2009-015019-42-Outside-EU/EEA
(EUCTR)
08/03/2012Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNAFemale: yes
Male: yes
170Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico
398EUCTR2016-003761-26-IT
(EUCTR)
10/11/2020Secukinumab safety and efficacy in JPsA and ERAA three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis - Secukinumab safety and efficacy in JPsA and ERA Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 1 SIRINGA PRERIEMPITA
Product Name: NA
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Spain;Poland;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy
399EUCTR2018-000681-10-FR
(EUCTR)
06/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
400EUCTR2008-005476-27-NO
(EUCTR)
09/03/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
122Phase 3France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
401EUCTR2021-001577-24-CZ
(EUCTR)
18/10/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE).
MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
402EUCTR2017-004495-60-AT
(EUCTR)
05/08/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan
403EUCTR2016-000940-32-Outside-EU/EEA
(EUCTR)
28/04/2016Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in JapanA Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents with Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response orIntolerance to Methotrexate or Biologics. Juvenile Idiopathic Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABATACEPT
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNAFemale: yes
Male: yes
23Phase 3Japan
404EUCTR2017-004495-60-DE
(EUCTR)
01/08/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
103Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan
405EUCTR2008-005479-82-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIAA randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
177Argentina;Brazil;Canada;Israel;Peru;Switzerland;Turkey;United States
406EUCTR2016-004223-23-FR
(EUCTR)
13/02/2017A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Other descriptive name: Fully human anti-interferon gamma monoclonal antibody
Novimmune SANULLNot RecruitingFemale: yes
Male: yes
10Phase 2United States;France;Canada;Spain;Netherlands;Italy;United Kingdom
407EUCTR2017-004471-31-AT
(EUCTR)
08/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic 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
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
236Phase 3Japan;China;Germany;Australia;Denmark;Belgium;Brazil;Poland;Argentina;Mexico;Czech Republic;France;India;Italy;United Kingdom;Russian Federation;Israel;Austria;Turkey;Spain;Czechia
408EUCTR2012-003054-92-BE
(EUCTR)
26/11/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Peru;Netherlands;Germany;Sweden
409EUCTR2018-001571-21-NL
(EUCTR)
23/05/2018Reducing side effects from methotrexate in juvenile arthritis treatmentTraining immune functions through pharmacotherapeutic conditioning injuvenile idiopathic arthritis - OPTI-MISS Juvenile Idiopathic Arthritis;Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]Trade Name: Methotrexate
Product Name: Methotrexate
Leiden UniversityNULLNAFemale: yes
Male: yes
132Phase 4Netherlands
410EUCTR2011-004915-22-SE
(EUCTR)
24/06/2021A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
340