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


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146

  
17 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2012-005026-30-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
2EUCTR2012-005026-30-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
3EUCTR2012-005026-30-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
4EUCTR2012-005026-30-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
5EUCTR2010-023802-10-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
6EUCTR2010-023802-10-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
7EUCTR2010-023802-10-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
8EUCTR2010-023802-10-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
9EUCTR2010-023802-10-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
10EUCTR2010-023802-10-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
11EUCTR2010-023802-10-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
12EUCTR2010-023802-10-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
13EUCTR2010-023802-10-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
14EUCTR2010-023802-10-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
15EUCTR2007-000255-34-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
16EUCTR2010-023802-10-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
17EUCTR2010-023802-10-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