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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04585711 (ClinicalTrials.gov) | July 2023 | 7/10/2020 | Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis | Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis | Juvenile Idiopathic Arthritis;Rheumatoid Arthritis;Obesity | Drug: Etanercept Optimal dosing | Duke University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not yet recruiting | 2 Years | 65 Years | All | 30 | Phase 1 | United States |
| 2 | EUCTR2021-004031-86-IT (EUCTR) | 21/12/2021 | 20/09/2021 | Efficacy and safety of anti TNF-alfa biosimilar compared to originators in Juvenile Idiopathic Arthritis | A 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 POLICLINICO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 4 | Italy | ||
| 3 | EUCTR2018-001931-27-IT (EUCTR) | 28/02/2019 | 11/10/2018 | Comparison of therapeutic strategies in childhood ARthritiS | Comparison 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 Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | Italy | ||
| 4 | NCT02840175 (ClinicalTrials.gov) | May 18, 2017 | 19/7/2016 | Treatment Tapering in JIA With Inactive Disease | Treatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic Therapy | Juvenile Idiopathic Arthritis | Drug: etanercept;Drug: adalimumab;Drug: Abatacept;Drug: Tocilizumab | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 2 Years | 17 Years | All | 62 | Phase 3 | France |
| 5 | EUCTR2016-000312-15-FR (EUCTR) | 12/08/2016 | 17/06/2016 | Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM | Treatment 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) | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | France | ||
| 6 | EUCTR2013-003956-18-NL (EUCTR) | 29/04/2014 | 13/01/2014 | Prevention 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 Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | United States;Canada;Latvia;Germany;Netherlands | |||
| 7 | EUCTR2012-005026-30-HU (EUCTR) | 15/08/2013 | 20/02/2013 | 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 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | ||
| 8 | EUCTR2012-005026-30-PL (EUCTR) | 17/05/2013 | 08/03/2013 | A Study Comparing SB4 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 9 | EUCTR2012-005026-30-CZ (EUCTR) | 15/05/2013 | 22/02/2013 | A Study Comparing SB4 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 10 | EUCTR2012-005026-30-BG (EUCTR) | 10/04/2013 | 05/03/2013 | A Study Comparing SB4 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 11 | EUCTR2010-023802-10-NL (EUCTR) | 07/05/2012 | 07/11/2011 | Study 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 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 States | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Netherlands;Germany;Latvia;Norway | ||
| 12 | EUCTR2010-023802-10-NO (EUCTR) | 22/02/2012 | 13/02/2012 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands | ||
| 13 | EUCTR2010-023802-10-IT (EUCTR) | 21/02/2012 | 02/04/2012 | Study 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 123 | Hungary;Colombia;Germany;Netherlands;Italy;Latvia;Australia;Lithuania;Russian Federation;Slovakia;Czech Republic;Mexico;Belgium;Slovenia;Spain | |||
| 14 | EUCTR2010-023802-10-BE (EUCTR) | 10/11/2011 | 09/06/2011 | Study Evaluation of the Long Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Czechia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway | ||
| 15 | EUCTR2010-023802-10-LV (EUCTR) | 28/10/2011 | 06/09/2011 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Latvia;Germany;Netherlands;Norway | ||
| 16 | NCT01421069 (ClinicalTrials.gov) | October 10, 2011 | 18/8/2011 | Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | AN 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 Arthritis | Drug: etanercept | Pfizer | NULL | Completed | 2 Years | 30 Years | All | 109 | Phase 3 | Australia;Belgium;Colombia;Czechia;France;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Netherlands;Norway;Poland;Russian Federation;Serbia;Slovakia;Slovenia;Spain;Czech Republic |
| 17 | EUCTR2010-023802-10-DE (EUCTR) | 29/09/2011 | 09/08/2011 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway | ||
| 18 | EUCTR2010-023802-10-LT (EUCTR) | 16/09/2011 | 20/06/2011 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway | ||
| 19 | EUCTR2010-023802-10-ES (EUCTR) | 15/09/2011 | 12/07/2011 | Study 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 123 | Hungary;Colombia;Germany;Netherlands;Norway;France;Italy;Latvia;Australia;Lithuania;Slovakia;Russian Federation;Czech Republic;Serbia;Slovenia;Belgium;Mexico;Spain;Poland | |||
| 20 | EUCTR2010-023802-10-CZ (EUCTR) | 08/09/2011 | 08/07/2011 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway | ||
| 21 | EUCTR2010-023802-10-SK (EUCTR) | 15/08/2011 | 21/06/2011 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands | ||
| 22 | EUCTR2010-023802-10-HU (EUCTR) | 29/07/2011 | 08/06/2011 | Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway | ||
| 23 | EUCTR2010-023802-10-FR (EUCTR) | 27/07/2011 | 10/06/2011 | Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Germany;Latvia;Netherlands;Norway | ||
| 24 | EUCTR2010-023802-10-SI (EUCTR) | 14/07/2011 | 12/07/2011 | Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovakia;Slovenia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands | ||
| 25 | EUCTR2010-020423-51-DE (EUCTR) | 17/02/2011 | 27/09/2010 | Remission 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 Augustin | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 26 | NCT01287715 (ClinicalTrials.gov) | January 2011 | 31/1/2011 | Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis | When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: etanercept | Erasmus Medical Center | Dutch Arthritis Association | Recruiting | 4 Years | 17 Years | Both | 50 | Phase 4 | Netherlands |
| 27 | EUCTR2009-012520-84-NL (EUCTR) | 19/05/2010 | 12/10/2009 | 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 | 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 | 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 Development | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Netherlands;Germany;Latvia;Sweden | |||
| 28 | EUCTR2009-012520-84-GR (EUCTR) | 22/03/2010 | 20/10/2009 | 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 | 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 | 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 Development | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Slovenia;Slovakia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden | ||
| 29 | EUCTR2009-012520-84-CZ (EUCTR) | 08/02/2010 | 31/07/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Latvia;Sweden | |||
| 30 | EUCTR2009-012520-84-DK (EUCTR) | 08/02/2010 | 10/11/2009 | 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 - | 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, USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Germany;Netherlands;France;Italy;Latvia;Sweden;Lithuania;Czech Republic;Denmark;Belgium;Slovenia;Spain;Greece | ||||
| 31 | EUCTR2009-012520-84-IT (EUCTR) | 28/01/2010 | 28/01/2010 | 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 - ND | 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 - 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 Development | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden | |||
| 32 | EUCTR2009-012520-84-LT (EUCTR) | 30/12/2009 | 01/10/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Latvia;Netherlands;Norway;Sweden | |||
| 33 | EUCTR2009-012520-84-DE (EUCTR) | 04/12/2009 | 07/07/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Latvia;Sweden | |||
| 34 | EUCTR2009-012520-84-BE (EUCTR) | 03/12/2009 | 22/07/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Slovakia;Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Latvia;Sweden | ||
| 35 | EUCTR2009-012520-84-LV (EUCTR) | 01/12/2009 | 16/10/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Latvia;Germany;Netherlands;Norway;Sweden | |||
| 36 | EUCTR2009-012520-84-ES (EUCTR) | 30/11/2009 | 21/08/2009 | 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? . | 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 Development | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Slovenia;Slovakia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden | ||
| 37 | EUCTR2009-012520-84-SI (EUCTR) | 02/10/2009 | 19/08/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Russian Federation;Italy;Egypt;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Latvia;Sweden | |||
| 38 | EUCTR2009-012520-84-SE (EUCTR) | 23/09/2009 | 27/08/2009 | 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 - | 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, USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Germany;Netherlands;France;Italy;Latvia;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Denmark;Spain;Greece | ||||
| 39 | EUCTR2009-012520-84-FR (EUCTR) | 21/09/2009 | 06/08/2009 | 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 - | 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 Development | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Hungary;Germany;Netherlands;France;Italy;Latvia;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Denmark;Spain;Greece | ||||
| 40 | EUCTR2009-012520-84-SK (EUCTR) | 09/09/2009 | 16/09/2009 | 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 | 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 | 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,USA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Slovakia;Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden | ||
| 41 | NCT00962741 (ClinicalTrials.gov) | September 2009 | 13/8/2009 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 | Arthritis, Juvenile Idiopathic | Drug: Etanercept | Pfizer | NULL | Completed | 2 Years | 17 Years | All | 127 | Phase 3 | Australia;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 |
| 42 | EUCTR2009-012520-84-HU (EUCTR) | 19/08/2009 | 06/07/2009 | 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 | 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 | 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 Development | NULL | Not Recruiting | Female: yes Male: yes | 100 | Slovenia;Greece;Spain;Lithuania;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Latvia;Sweden | |||
| 43 | NCT01145352 (ClinicalTrials.gov) | July 2009 | 9/6/2010 | Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] | Enbrel-JIA Use Results Survey [All-Case Surveillance] | Juvenile Idiopathic Arthritis | Drug: Etanercept (genetical recombination) | Pfizer | NULL | Completed | 5 Years | 16 Years | All | 113 | N/A | Japan |
| 44 | EUCTR2007-000255-34-DE (EUCTR) | 05/06/2007 | 09/05/2007 | a 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 | a 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 Augustin | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | Germany | ||
| 45 | NCT00443430 (ClinicalTrials.gov) | May 2007 | 2/3/2007 | Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis | Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) | Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid Arthritis | Drug: methotrexate;Drug: methotrexate - etanercept - prednisolone arm | Seattle Children's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Amgen | Completed | 2 Years | 17 Years | All | 85 | Phase 4 | United States |
| 46 | NCT00195377 (ClinicalTrials.gov) | April 2003 | 13/9/2005 | Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain | Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study | Arthritis, Psoriatic;Arthritis, Rheumatoid | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 4 Years | N/A | Both | 1000 | Spain | |
| 47 | EUCTR2009-012520-84-Outside-EU/EEA (EUCTR) | 30/01/2012 | Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | 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 - 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 USA | NULL | NA | Female: yes Male: yes | 100 | Australia;Colombia;Mexico;Russian Federation;Serbia | ||||
| 48 | EUCTR2012-001145-40-Outside-EU/EEA (EUCTR) | 07/03/2012 | Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritis | Open-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 91320 | NULL | NA | Female: yes Male: yes | 783 | Canada;United States | ||||
| 49 | EUCTR2010-023802-10-Outside-EU/EEA (EUCTR) | 30/01/2012 | Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | NA | Female: yes Male: yes | 123 | Russian Federation;Serbia;Australia;Colombia;Mexico | ||||
| 50 | EUCTR2010-023802-10-PL (EUCTR) | 20/09/2011 | Study Evaluation of the Long-Term Safety and Clinical Benefit of Etanercept In 3 Sub-types of Childhood Arthritis | AN 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 3 | Serbia;Slovenia;Slovakia;Spain;Lithuania;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Norway;Germany;Latvia;Netherlands | |||
| 51 | EUCTR2012-001171-37-Outside-EU/EEA (EUCTR) | 07/03/2012 | Study evaluating safety and effectiveness in children with childhood arthritis | A 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 91320 | NULL | NA | Female: yes Male: yes | 594 | Phase 4 | Canada;United States |