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
| 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 | 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 | ||
| 2 | EUCTR2018-000681-10-CZ (EUCTR) | 25/02/2021 | 22/12/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Belgium;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Switzerland | ||
| 3 | EUCTR2018-000681-10-IT (EUCTR) | 23/12/2020 | 24/05/2021 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis - TALZ | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) Product Name: Ixekizumab Product Code: [TALTZ] INN or Proposed INN: ixekizumab Trade Name: Humira Product Name: Humira Product Code: [L04AB04] INN or Proposed INN: Adalimumab | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 4 | EUCTR2018-000681-10-DK (EUCTR) | 14/12/2020 | 31/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 5 | EUCTR2018-000681-10-GB (EUCTR) | 24/11/2020 | 11/09/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom | ||
| 6 | EUCTR2018-000681-10-DE (EUCTR) | 23/11/2020 | 07/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 7 | EUCTR2019-000119-10-DE (EUCTR) | 20/01/2020 | 25/06/2019 | A study of Baricitinib in children and young adults with JIA associated eye inflammation | An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT | Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France;Spain;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2019-000412-29-GB (EUCTR) | 18/10/2019 | 25/03/2019 | Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST) | Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST) - ADJUST | juvenile-idiopathic arthritispaediatric uveitis MedDRA version: 20.0;Level: LLT;Classification code 10022557;Term: Intermediate uveitis;System Organ Class: 100000004853 MedDRA version: 20.0;Classification code 10033687;Term: Panuveitis;System Organ Class: 100000004853 MedDRA version: 20.1;Classification code 10036370;Term: Posterior uveitis;System Organ Class: 100000004862 MedDRA version: 20.1;Classification code 10066681;Term: Acute uveitis;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | F.I. Proctor Foundation, University of California San Francisco | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 118 | Phase 4 | United States;United Kingdom;Australia | ||
| 9 | EUCTR2019-000119-10-IT (EUCTR) | 08/10/2019 | 17/06/2021 | A study of Baricitinib in children and young adults with JIA associated eye inflammation | An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT | Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Trade Name: SUB180983 Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Humira Product Name: Humira Product Code: [Humira] INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: [L04AB04] INN or Proposed INN: ADALIMUMAB | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France;European Union;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2019-000119-10-FR (EUCTR) | 14/08/2019 | 29/05/2019 | A study of Baricitinib in children and young adults with JIA associated eye inflammation | An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT | Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France;Germany;United Kingdom | ||
| 11 | EUCTR2019-000119-10-GB (EUCTR) | 06/08/2019 | 17/04/2019 | A study of Baricitinib in children and young adults with JIA associated eye inflammation | An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT | Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France;Germany;United Kingdom | ||
| 12 | 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 | ||
| 13 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 14 | 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 | |||
| 15 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 16 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 17 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 18 | EUCTR2009-013091-40-CZ (EUCTR) | 25/05/2010 | 23/02/2010 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859 | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | France;Czech Republic;Germany;Sweden | |||
| 19 | EUCTR2009-013091-40-DE (EUCTR) | 17/05/2010 | 11/12/2009 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | France;Czech Republic;Germany;Sweden | |||
| 20 | EUCTR2009-013091-40-DK (EUCTR) | 05/05/2010 | 08/03/2010 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Czech Republic;Denmark;Germany;Sweden | ||
| 21 | EUCTR2009-013091-40-SE (EUCTR) | 12/04/2010 | 04/02/2010 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859 | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | France;Czech Republic;Germany;Sweden | |||
| 22 | EUCTR2009-013091-40-SK (EUCTR) | 03/03/2010 | 04/02/2010 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Czech Republic;Slovakia;Denmark;Germany;Sweden | ||
| 23 | EUCTR2009-013091-40-FR (EUCTR) | 22/02/2010 | 10/12/2009 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Denmark;Germany;Sweden | ||
| 24 | EUCTR2009-013091-40-Outside-EU/EEA (EUCTR) | 07/02/2012 | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 30 | NULL | ||||
| 25 | EUCTR2018-000681-10-FR (EUCTR) | 06/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | |||
| 26 | EUCTR2018-000681-10-NL (EUCTR) | 07/01/2021 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Italy | |||
| 27 | EUCTR2018-000681-10-BE (EUCTR) | 22/10/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy |