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 : 292 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142

  
51 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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agemin
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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
2EUCTR2021-004031-86-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
3EUCTR2018-001931-27-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
4NCT02840175
(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
5EUCTR2016-000312-15-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
6EUCTR2013-003956-18-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
7EUCTR2012-005026-30-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
8EUCTR2012-005026-30-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
9EUCTR2012-005026-30-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
10EUCTR2012-005026-30-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
11EUCTR2010-023802-10-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
12EUCTR2010-023802-10-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
13EUCTR2010-023802-10-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
14EUCTR2010-023802-10-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
15EUCTR2010-023802-10-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
16NCT01421069
(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
17EUCTR2010-023802-10-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
18EUCTR2010-023802-10-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
19EUCTR2010-023802-10-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
20EUCTR2010-023802-10-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
21EUCTR2010-023802-10-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
22EUCTR2010-023802-10-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
23EUCTR2010-023802-10-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
24EUCTR2010-023802-10-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
25EUCTR2010-020423-51-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
26NCT01287715
(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
27EUCTR2009-012520-84-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
28EUCTR2009-012520-84-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
29EUCTR2009-012520-84-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
30EUCTR2009-012520-84-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
31EUCTR2009-012520-84-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
32EUCTR2009-012520-84-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
33EUCTR2009-012520-84-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
34EUCTR2009-012520-84-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
35EUCTR2009-012520-84-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
36EUCTR2009-012520-84-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
37EUCTR2009-012520-84-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
38EUCTR2009-012520-84-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
39EUCTR2009-012520-84-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
40EUCTR2009-012520-84-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
41NCT00962741
(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
42EUCTR2009-012520-84-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
43NCT01145352
(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
44EUCTR2007-000255-34-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
45NCT00443430
(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
46NCT00195377
(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
47EUCTR2009-012520-84-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
48EUCTR2012-001171-37-Outside-EU/EEA
(EUCTR)
07/03/2012Study evaluating safety and effectiveness in children with childhood arthritisA Phase IV Registry of Etanercept in Children With Juvenile Rheumatoid Arthritis Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320NULLNAFemale: yes
Male: yes
594Phase 4Canada;United States
49EUCTR2010-023802-10-Outside-EU/EEA
(EUCTR)
30/01/2012Study 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: 14.1;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
Trade Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNAFemale: yes
Male: yes
123Russian Federation;Serbia;Australia;Colombia;Mexico
50EUCTR2010-023802-10-PL
(EUCTR)
20/09/2011Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood ArthritisAN OPEN-LABEL EXTENSION STUDY TO ASSESS 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
51EUCTR2012-001145-40-Outside-EU/EEA
(EUCTR)
07/03/2012Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritisOpen-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320NULLNAFemale: yes
Male: yes
783Canada;United States