271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 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 | NCT04527380 (ClinicalTrials.gov) | April 13, 2021 | 24/8/2020 | A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic 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 Psoriatic Arthritis;Enthesitis Related Arthritis | Drug: Ixekizumab;Drug: Adalimumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom |
| 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 | NCT01870284 (ClinicalTrials.gov) | July 2014 | 3/6/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Ixekizumab;Drug: Placebo;Drug: Adalimumab | Eli Lilly and Company | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 8 | EUCTR2011-002325-22-ES (EUCTR) | 28/10/2013 | 08/08/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 9 | EUCTR2011-002325-22-BE (EUCTR) | 28/10/2013 | 09/08/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany | |||
| 10 | EUCTR2011-002325-22-DE (EUCTR) | 25/10/2013 | 09/08/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 11 | EUCTR2011-002325-22-GB (EUCTR) | 26/09/2013 | 18/06/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | ||
| 12 | EUCTR2011-002325-22-HU (EUCTR) | 26/09/2013 | 17/07/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 13 | 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 | |||
| 14 | 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 | |||
| 15 | 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 |