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 | NCT05609630 (ClinicalTrials.gov) | March 15, 2023 | 7/11/2022 | Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. | A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Upadacitinib;Drug: Tocilizumab | AbbVie | NULL | Not yet recruiting | 1 Year | 17 Years | All | 90 | Phase 3 | NULL |
| 2 | EUCTR2022-003024-41-ES (EUCTR) | 25/01/2023 | 25/11/2022 | Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis | Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG 407 INN or Proposed INN: Apremilast | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland | ||
| 3 | NCT05534347 (ClinicalTrials.gov) | September 2022 | 6/9/2022 | Angiogenic Biomarkers in Juvenile Idiopathic Arthritis | Angiogenic Inflammatory Biomarkers in Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis (JIA) | Biological: Blood sample;Biological: Joint puncture | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 16 Years | N/A | All | 300 | France | |
| 4 | JPRN-jRCT2031220187 | 01/08/2022 | 07/07/2022 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE | A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's Disease (Including Systemic Juvenile Idiopathic Arthritis and Adult Onset Still's Disease) or with MAS in Systemic Lupus Erythematosus - EMERALD | Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, SLE | Emapalumab iv infusion initial dose: 6 mg/kg Subsequent doses: 3 mg/kg | Nakaoku Takahiro | NULL | Recruiting | >= 6month old | <= 80age old | Both | 2 | Phase 2-3 | Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;United States;Japan |
| 5 | NCT05540743 (ClinicalTrials.gov) | July 1, 2022 | 12/9/2022 | Biologic Therapy in Pediatric JIA Uveitis | The Efficacy of Anti-TNF Alpha Agents in the Treatment of JIA- Associated Uveitis in a Pediatric Cohort | Juvenile Idiopathic Arthritis Associated Uveitis | Drug: biologic DMARDs | Kasr El Aini Hospital | NULL | Active, not recruiting | 3 Months | 16 Years | All | 250 | Phase 4 | Egypt |
| 6 | JPRN-jRCT2031220222 | 01/07/2022 | 25/07/2022 | Sobi.ANAKIN-303 | A randomized, double-blind, placebo-controlled, multicenter, phase 3 efficacy and safety study of subcutaneous anakinra in Japanese patients with Still's disease (SJIA and AOSD) | Systemic juvenile idiopathic arthritis(SJIA)., adult-onset Still's disease (AOSD) | - Pediatric and adult patients weighing >_ 50kg:Anakinra 100mg/day - Pediatric and adult patients weighing < 50 kg:should be dosed by body weight with a starting dose of 2mg/kg/day of anakinra (with a maximum of 100mg/day) | Takeshi KUROSAWA | NULL | Recruiting | >= 8month old | Not applicable | Both | 15 | Phase 3 | Japan |
| 7 | EUCTR2011-004915-22-NL (EUCTR) | 17/05/2022 | 05/02/2021 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany;Netherlands;China;Sweden | ||
| 8 | EUCTR2019-002788-88-GR (EUCTR) | 14/04/2022 | 01/02/2022 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Poland;Belgium;Austria;Netherlands;Italy | ||
| 9 | EUCTR2017-002018-29-HU (EUCTR) | 04/01/2022 | 25/10/2021 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden | ||
| 10 | 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 | ||
| 11 | EUCTR2021-001577-24-ES (EUCTR) | 15/12/2021 | 25/08/2021 | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | ||
| 12 | EUCTR2021-001577-24-PL (EUCTR) | 31/10/2021 | 28/09/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany;China;Japan;Sweden | ||
| 13 | EUCTR2017-002018-29-NL (EUCTR) | 19/10/2021 | 10/12/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: Tofacitinib Other descriptive name: APD421 | Pfizer Inc. 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Germany;Netherlands;China;Sweden | ||
| 14 | EUCTR2019-002788-88-NL (EUCTR) | 23/09/2021 | 18/02/2021 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 15 | NCT05027373 (ClinicalTrials.gov) | August 13, 2021 | 17/8/2021 | Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection | A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1ß Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects | Systemic Juvenile Idiopathic Arthritis;Periodic Fever Syndrome | Drug: SSGJ-613;Drug: Placebo | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 34 | Phase 1 | China |
| 16 | EUCTR2015-004000-35-IE (EUCTR) | 24/06/2021 | 19/02/2021 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Argentina;Poland;Bulgaria;Netherlands;Germany;Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada | ||
| 17 | NCT04902807 (ClinicalTrials.gov) | June 2021 | 21/5/2021 | Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation | Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation | Autoimmune Lymphoproliferative Syndrome;Autoimmune Cytopenia;Autoimmune Diseases;Autoimmune Anemia;Autoimmune Thrombocytopenia;Autoimmune Hepatitis;Autoimmune Diabetes;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Juvenile Idiopathic Arthritis;Hemophagocytic Lymphohistiocytoses;EBV Lymphoproliferation;RAS-Associated Autoimmune Leucoproliferative Disease;Primary Immunodeficiency;APECED;IPEX;BENTA;Enteropathy, Autoimmune;Combined Immunodeficiency;IBD | Biological: Collection of samples | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Not yet recruiting | 1 Year | 18 Years | All | 500 | NULL | |
| 18 | EUCTR2019-002788-88-FR (EUCTR) | 15/04/2021 | 18/12/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands | ||
| 19 | 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 |
| 20 | NCT04752371 (ClinicalTrials.gov) | March 25, 2021 | 9/2/2021 | A Study to Evaluate Camoteskimab in Participants With Still's Disease (AOSD/sJIA) | A Phase 1b/2a, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Camoteskimab in Subjects With Still's Disease (sJIA/AOSD) | Adult Onset Still's Disease;Systemic Juvenile Idiopathic Arthritis | Drug: Camoteskimab (CERC-007, AVTX-007, AEVI-007) | Apollo Therapeutics Ltd | NULL | Recruiting | 6 Years | 75 Years | All | 20 | Phase 2 | United States;Belgium;Poland;Ukraine |
| 21 | EUCTR2019-002788-88-IT (EUCTR) | 11/03/2021 | 20/05/2021 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) - PEAPOD | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast 20 mg Product Code: [AMG407] INN or Proposed INN: Apremilast Trade Name: OTEZLA - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE Product Name: Apremilast 30 mg Product Code: [AMG407] INN or Proposed INN: Apremilast Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast 10 mg Product Code: [AMG407] INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: [AMG407] INN or Proposed INN: Apremilast | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Spain;Belgium;Austria;Netherlands;Germany;Italy | ||
| 22 | 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 | ||
| 23 | EUCTR2017-002018-29-DE (EUCTR) | 02/02/2021 | 23/09/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Eritrea;South Africa;Netherlands;Germany;China;Sweden | ||
| 24 | EUCTR2015-004000-35-BG (EUCTR) | 12/01/2021 | 12/11/2020 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Bulgaria;Netherlands;Germany | ||
| 25 | EUCTR2019-002788-88-AT (EUCTR) | 11/01/2021 | 05/11/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Poland;Belgium;Austria;Netherlands;Italy | ||
| 26 | NCT04775225 (ClinicalTrials.gov) | January 6, 2021 | 17/2/2021 | Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis | Hip Denervation in Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis;Hip Arthritis | Drug: Lidocaine;Drug: Placebo;Drug: Steroid | Sohag University | NULL | Completed | 2 Years | 18 Years | All | 120 | Phase 3 | Egypt |
| 27 | 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 | ||
| 28 | EUCTR2017-002018-29-IT (EUCTR) | 15/12/2020 | 06/11/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS - . | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: [CP-690, 550-10] INN or Proposed INN: Tofacitinib Product Name: tofacitinib citrate Product Code: [CCP-690-550-10] INN or Proposed INN: Tofacitinib | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Netherlands;Germany;China;Sweden | ||
| 29 | 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 | ||
| 30 | EUCTR2017-002018-29-SK (EUCTR) | 09/12/2020 | 04/08/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Germany;Netherlands;China;Sweden | ||
| 31 | NCT04687930 (ClinicalTrials.gov) | December 1, 2020 | 19/12/2020 | Genicular Nerve Block in Juvenile Idiopathic Arthritis | Genicular Nerve Block in Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis;Persistent Knee Arthritis;no Intra-articular Injection in the Last 3 Months;no Other Cause for Chronic Kneearthritis | Drug: genicular nerve block;Drug: intra-articular steroid injection | Sohag University | NULL | Completed | N/A | 16 Years | All | 104 | Phase 4 | Egypt |
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | EUCTR2017-002018-29-PL (EUCTR) | 28/10/2020 | 09/08/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;South Africa;Netherlands;Germany;China;Sweden | ||
| 35 | EUCTR2019-000889-38-NO (EUCTR) | 16/09/2020 | 18/06/2020 | Personalised treatment of my juvenile arthritis | Strategies towards personalised treatment in Juvenile Idiopathic Arthritis (JIA): An open randomised multicentre blinded-assessor trial assessing the effectiveness of intra-articular glucocorticoid injections in JIA patients starting tumour necrosis factor inhibitor treatment - MyJIA | Juvenile idiopathic arthritis is characterised by inflamed joints and is the most common chronic rheumatic disease in childhood and adolescence that potentially lead to disability due to joint damage. A prerequisite for the JIA diagnosis is the detection of inflammation of one or more joints (arthritis). Arthritis leads to pain, swelling and stiffness of the affected joints, caused by hypertrophy of the synovial lining of the joint and increased synovial fluid. Untreated, disability may follow.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Lederspan INN or Proposed INN: TRIAMCINOLONE HEXACETONIDE | Oslo University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 202 | Phase 4 | Norway | ||
| 36 | EUCTR2018-004284-30-DE (EUCTR) | 13/02/2020 | 29/07/2019 | Repsonse to Treatment with Canakinumab without steroids early after diagnosis of systemic onset juvenile idiopathic arthritis / juvenile Still’s disease | Effectiveness of Canakinumab for first line steroid free treatment in systemic onset juvenile idiopathic arthritis / juvenile Still’s disease - CANAKINUMAB FIRST | systemic juvenile idiopathic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ilaris Product Name: Ilaris | Asklepios Klink Sankt Augustin | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Germany | ||
| 37 | NCT04088396 (ClinicalTrials.gov) | February 12, 2020 | 11/9/2019 | A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA | Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis | Systemic Juvenile Idiopathic Arthritis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 1 Year | 17 Years | All | 103 | Phase 3 | Argentina;Austria;Belgium;Brazil;Czechia;Denmark;France;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom;Germany |
| 38 | 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 | ||
| 39 | EUCTR2017-004495-60-PL (EUCTR) | 12/12/2019 | 23/10/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan | ||
| 40 | EUCTR2017-004495-60-DK (EUCTR) | 20/11/2019 | 21/11/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Argentina;Russian Federation;Japan;United Kingdom;India;Spain;Austria;Czech Republic;Turkey;Belgium;China;Denmark;Brazil;Poland;Italy;Mexico;Israel;France;Germany | ||
| 41 | 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 | ||
| 42 | NCT04088409 (ClinicalTrials.gov) | October 16, 2019 | 11/9/2019 | A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis | 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 | Uveitis | Drug: Baricitinib;Drug: Adalimumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 17 Years | All | 40 | Phase 3 | France;Germany;Italy;Spain;United Kingdom |
| 43 | EUCTR2017-004471-31-FR (EUCTR) | 15/10/2019 | 05/08/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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: 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 44 | 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 | ||
| 45 | EUCTR2017-004518-24-FR (EUCTR) | 03/10/2019 | 05/08/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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: 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 46 | EUCTR2017-004495-60-FR (EUCTR) | 24/09/2019 | 10/07/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 97 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan | ||
| 47 | EUCTR2017-004495-60-IT (EUCTR) | 16/09/2019 | 17/06/2021 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less Than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Product Name: OLUMIANT Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Product Name: OLUMIANT Product Code: [LY3009104] INN or Proposed INN: BARICITINIB | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan | ||
| 48 | EUCTR2017-004495-60-GB (EUCTR) | 19/08/2019 | 11/07/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | ||
| 49 | 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 | ||
| 50 | EUCTR2017-004471-31-BE (EUCTR) | 09/08/2019 | 06/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Poland;Denmark;Australia;Germany;China;Japan | ||
| 51 | 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 | ||
| 52 | EUCTR2017-004471-31-DE (EUCTR) | 17/07/2019 | 03/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 53 | EUCTR2017-004518-24-BE (EUCTR) | 16/07/2019 | 14/08/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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: 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 54 | EUCTR2017-004518-24-PL (EUCTR) | 09/07/2019 | 27/06/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 55 | EUCTR2017-004471-31-PL (EUCTR) | 02/07/2019 | 19/06/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 56 | EUCTR2017-004518-24-DE (EUCTR) | 27/06/2019 | 03/05/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan | ||
| 57 | NCT03725007 (ClinicalTrials.gov) | June 24, 2019 | 27/10/2018 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis | An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis (JIA) | Drug: Upadacitinib | AbbVie | NULL | Recruiting | 2 Years | 17 Years | All | 124 | Phase 1 | United States;Canada;Germany;Hungary;Israel;Italy;Japan;Puerto Rico;Spain;Sweden |
| 58 | EUCTR2017-004518-24-DK (EUCTR) | 13/06/2019 | 30/04/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Germany;Japan;China | ||
| 59 | EUCTR2017-004471-31-DK (EUCTR) | 13/06/2019 | 01/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Germany;Japan;China | ||
| 60 | NCT03984669 (ClinicalTrials.gov) | June 11, 2019 | 11/6/2019 | (1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy | (1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy | Juvenile Idiopathic Arthritis | Diagnostic Test: The Juvenile Disease Activity Score (JADAS);Biological: (1-3)-ß-D-Glucan (BDG) assay (Fungitell) | Centre Hospitalier Universitaire, Amiens | NULL | Completed | N/A | 18 Years | All | 40 | N/A | France |
| 61 | EUCTR2017-004471-31-GB (EUCTR) | 29/05/2019 | 13/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 62 | EUCTR2017-004471-31-ES (EUCTR) | 27/05/2019 | 29/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Lilly S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 63 | EUCTR2017-004518-24-CZ (EUCTR) | 27/05/2019 | 02/05/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) - JUVE-BASIS | 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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Germany;China;Japan | ||
| 64 | EUCTR2017-004471-31-CZ (EUCTR) | 27/05/2019 | 03/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan | ||
| 65 | EUCTR2017-004518-24-ES (EUCTR) | 22/05/2019 | 27/05/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic 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] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Lilly S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 66 | EUCTR2017-004518-24-AT (EUCTR) | 22/05/2019 | 07/05/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan | ||
| 67 | EUCTR2017-004471-31-IT (EUCTR) | 21/05/2019 | 15/06/2021 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) - NA | 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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: olumiant Product Code: [LY3009104] Trade Name: Olumiant Product Name: OLUMIANT Product Code: [LY3009104] Product Name: olumiant Product Code: [LY3009104] Product Name: Olumiant Product Code: [LY3009104] | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan | ||
| 68 | EUCTR2018-000715-25-ES (EUCTR) | 21/05/2019 | 27/05/2019 | Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) | An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis | Polyarticular Course Juvenile Idiopathic 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] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 1;Phase 3 | United States;Hungary;Spain;Germany;Italy | ||
| 69 | EUCTR2017-004518-24-IT (EUCTR) | 17/05/2019 | 17/06/2021 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) - na | Juvenile Idiopathic Arthritis (JIA) 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: olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib Trade Name: oluminant 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 Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan | ||
| 70 | EUCTR2018-002521-30-DE (EUCTR) | 09/05/2019 | 08/01/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy | ||
| 71 | EUCTR2017-004518-24-GB (EUCTR) | 23/04/2019 | 07/02/2019 | A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 72 | EUCTR2015-001438-46-PL (EUCTR) | 16/04/2019 | 30/01/2018 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany | ||
| 73 | EUCTR2018-002521-30-IT (EUCTR) | 16/04/2019 | 15/06/2021 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis - Secukinumab long-term safety, tolerability and efficacy in JPsA and ERA up to 4 years | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 2 SIRINGHE PRERIEMPITE Product Name: - Product Code: [-] INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: [AIN457] INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy | ||
| 74 | EUCTR2018-000715-25-DE (EUCTR) | 16/04/2019 | 07/01/2019 | Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) | An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis | Polyarticular Course 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1 | United States;Hungary;Spain;Germany;Italy | ||
| 75 | NCT03932344 (ClinicalTrials.gov) | April 10, 2019 | 16/4/2019 | Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis | Still Disease, Juvenile Onset | Drug: Anakinra | Swedish Orphan Biovitrum | NULL | Completed | N/A | N/A | All | 306 | Italy | |
| 76 | NCT03773965 (ClinicalTrials.gov) | April 5, 2019 | 11/12/2018 | A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis | Drug: Baricitinib | Eli Lilly and Company | NULL | Recruiting | 1 Year | 18 Years | All | 190 | Phase 3 | Argentina;Australia;Austria;Belgium;Brazil;China;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom |
| 77 | EUCTR2018-000715-25-IT (EUCTR) | 20/03/2019 | 17/06/2021 | Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) | An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis - na | Polyarticular Course 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: na Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: na Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: na Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: na | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 1 | United States;Hungary;Spain;Germany;Italy | ||
| 78 | EUCTR2018-000715-25-HU (EUCTR) | 18/03/2019 | 23/01/2019 | Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) | An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis | Polyarticular Course Juvenile Idiopathic 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] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Spain;Germany;Italy | ||
| 79 | EUCTR2018-002521-30-ES (EUCTR) | 15/03/2019 | 27/03/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Belgium;Spain;Turkey;Russian Federation;South Africa;Germany;Italy | ||
| 80 | 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 | ||
| 81 | EUCTR2018-002245-11-NL (EUCTR) | 16/01/2019 | 20/08/2018 | A study to investigate Vitamin B3 concentrations in the joint after intake | Assessing penetration of high dose Nicotinamide (Vitamin B3) in synovial fluid - B-Vit in the joint | Juvenile Idiopathic Arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: nicotinamide Product Code: 98-92-0 INN or Proposed INN: NICOTINAMIDE Other descriptive name: Vitamin B3 | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 82 | NCT03773978 (ClinicalTrials.gov) | December 17, 2018 | 11/12/2018 | A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 2 Years | 17 Years | All | 220 | Phase 3 | Argentina;Australia;Austria;Belgium;Brazil;China;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom |
| 83 | NCT03833271 (ClinicalTrials.gov) | October 28, 2018 | 21/1/2019 | The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary | The Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy Control | Juvenile Idiopathic Arthritis | Biological: Influenza vaccine, Immune function | University of Pecs | NULL | Completed | 3 Years | 18 Years | All | 62 | Early Phase 1 | Hungary |
| 84 | EUCTR2016-004223-23-NL (EUCTR) | 09/08/2018 | 13/02/2018 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | France;United States;Canada;Spain;Germany;Netherlands;United Kingdom;Italy | ||
| 85 | NCT03000439 (ClinicalTrials.gov) | May 10, 2018 | 9/11/2016 | A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Arthritis Juvenile Idiopathic | Drug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio | Pfizer | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;China;Costa Rica;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Chile;Netherlands |
| 86 | NCT03301883 (ClinicalTrials.gov) | April 26, 2018 | 21/9/2017 | A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA) | A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab;Drug: NSAIDs;Drug: CSs;Drug: MTX | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 62 | Phase 4 | China |
| 87 | EUCTR2015-001438-46-DE (EUCTR) | 16/04/2018 | 13/12/2017 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FORTREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHICARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Argentina;Russian Federation;United States;Ukraine;United Kingdom;Switzerland;Spain;Canada;Turkey;Belgium;Brazil;Poland;Mexico;South Africa;Israel;Australia;Chile;Germany | ||
| 88 | EUCTR2015-001438-46-ES (EUCTR) | 05/04/2018 | 21/12/2017 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany | ||
| 89 | EUCTR2011-004915-22-GB (EUCTR) | 03/04/2018 | 21/12/2017 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 90 | EUCTR2015-001438-46-GB (EUCTR) | 27/03/2018 | 28/11/2017 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FORTREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHICARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Switzerland;United Kingdom;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;South Africa;Germany | ||
| 91 | EUCTR2011-004915-22-BE (EUCTR) | 16/03/2018 | 02/01/2018 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: Tofacitinib Other descriptive name: APD421 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | NA | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;South Africa;Germany;Netherlands;China;Sweden | ||
| 92 | NCT03311854 (ClinicalTrials.gov) | February 20, 2018 | 21/8/2017 | A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) | A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFN?) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) | Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset Still Disease | Drug: Emapalumab | Swedish Orphan Biovitrum | NULL | Completed | N/A | N/A | All | 14 | Phase 2 | United States;France;Italy;Spain;United Kingdom;Netherlands |
| 93 | EUCTR2015-001438-46-BE (EUCTR) | 19/02/2018 | 06/12/2017 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany | ||
| 94 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 95 | ChiCTR-OPB-17013704 | 2017-12-20 | 2017-12-05 | A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis | A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis | systemic juvenile idiopathic arthritis | Case series:Tocilizumab; | Children's Hospital of Chongqing Medical University | NULL | Recruiting | 2 | 17 | Both | Case series:65; | Phase 4 | China |
| 96 | EUCTR2015-004000-35-DE (EUCTR) | 16/11/2017 | 19/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | ||
| 97 | EUCTR2016-004223-23-ES (EUCTR) | 25/09/2017 | 09/06/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: NI-0501 INN or Proposed INN: Emapalumab Other descriptive name: NI-0501 | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 98 | EUCTR2016-004223-23-GB (EUCTR) | 12/09/2017 | 02/03/2017 | A study to investigate a new medication, emapalumab, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB | Swedish Orphan Biovitrum AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Canada;Spain;Netherlands;Italy;United Kingdom | ||
| 99 | NCT03092427 (ClinicalTrials.gov) | September 4, 2017 | 21/3/2017 | Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA) | Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis | Dietary Supplement: VSL#3;Other: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 1 Year | 7 Years | All | 51 | N/A | France |
| 100 | ChiCTR-INR-17011829 | 2017-08-01 | 2017-07-02 | Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab | Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab | Systemic onset juvenile idiopathic arthritis | Case:Tocilizumab;Control:Conventional Treatment; | Shenzhen Children's Hospital | NULL | Pending | Both | Case:75;Control:75; | China | |||
| 101 | EUCTR2016-003761-26-PL (EUCTR) | 30/06/2017 | 24/05/2017 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Belgium;Poland;Turkey;South Africa;Russian Federation;Germany;United Kingdom;Italy | ||
| 102 | EUCTR2016-003761-26-BE (EUCTR) | 15/06/2017 | 16/03/2017 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;United Kingdom;Italy | ||
| 103 | 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 |
| 104 | EUCTR2015-004000-35-NL (EUCTR) | 19/04/2017 | 07/12/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Netherlands;Germany | ||
| 105 | EUCTR2016-004223-23-IT (EUCTR) | 14/04/2017 | 25/01/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: NI-0501 | Novimmune SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 106 | EUCTR2016-003761-26-GB (EUCTR) | 10/03/2017 | 13/12/2016 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy;United Kingdom | ||
| 107 | EUCTR2016-003761-26-ES (EUCTR) | 01/03/2017 | 15/12/2016 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Poland;Belgium;Spain;Turkey;South Africa;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 108 | EUCTR2015-004000-35-GB (EUCTR) | 24/02/2017 | 18/08/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | ||
| 109 | EUCTR2015-003999-79-DE (EUCTR) | 22/02/2017 | 14/07/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP | Juvenile idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 110 | EUCTR2015-004000-35-PL (EUCTR) | 13/02/2017 | 05/12/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic 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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | Argentina;Russian Federation;United States;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Ireland;Finland;Poland;Italy;Mexico;Chile;France;Bulgaria;Germany;Estonia | ||
| 111 | EUCTR2016-003761-26-DE (EUCTR) | 06/02/2017 | 12/12/2016 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | United States;Poland;Belgium;Spain;Turkey;Russian Federation;South Africa;Germany;Italy;United Kingdom | ||
| 112 | NCT03069638 (ClinicalTrials.gov) | February 1, 2017 | 20/12/2016 | Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population | Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population | Juvenile Idiopathic Arthritis;Joint Inflammation | Drug: Dexmedetomidine;Drug: Sedatives/Hypnotics,Other | University of Oulu | NULL | Recruiting | 1 Year | 18 Years | All | 109 | Phase 4 | Finland |
| 113 | EUCTR2015-004000-35-FI (EUCTR) | 12/12/2016 | 06/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Bulgaria;Germany;Netherlands | ||
| 114 | EUCTR2015-004000-35-EE (EUCTR) | 15/11/2016 | 04/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis MedDRA version: 19.0;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 115 | EUCTR2015-004000-35-ES (EUCTR) | 10/11/2016 | 26/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis MedDRA version: 19.0;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 116 | EUCTR2015-004000-35-IT (EUCTR) | 17/10/2016 | 07/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis MedDRA version: 19.0;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 117 | EUCTR2015-004393-16-NL (EUCTR) | 04/10/2016 | 08/07/2016 | Biomarker-guided treatment-and-stop-strategy for short acting IL-1 blockade in patients with systemic Juvenile Idiopathic Arthritis. | Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis. - ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA | systemic Juvenile Idiopathic Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: kineret® or anakinra Product Name: anakinra / kineret Product Code: not applicable INN or Proposed INN: ANAKINRA Other descriptive name: rIL-1RA | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 118 | JPRN-UMIN000024178 | 2016/09/28 | 28/09/2016 | Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis | Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis - Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis | Systemic-onset juvenile idiopathic arthritis(sJIA) | Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeks | Yokohama City University Hospital Department of Pediatrics | NULL | Recruiting | 2years-old | Not applicable | Male and Female | 5 | Not selected | Japan |
| 119 | EUCTR2015-003999-79-NL (EUCTR) | 28/09/2016 | 01/06/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis MedDRA version: 19.1;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 120 | ChiCTR-OPC-17011391 | 2016-09-01 | 2017-05-12 | The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China | The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China | systemic juvenile idiopathic arthritis | tocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid; | Children's Hospital of Chongqing Medical University | NULL | Completed | 2 | 16 | Both | tocilizumab group:36;glucocorticoid group:24; | China | |
| 121 | EUCTR2015-003999-79-PL (EUCTR) | 22/08/2016 | 07/07/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | ||
| 122 | 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 | ||
| 123 | EUCTR2015-003999-79-IT (EUCTR) | 10/06/2016 | 07/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis MedDRA version: 18.1;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 124 | NCT02592434 (ClinicalTrials.gov) | June 10, 2016 | 14/8/2015 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | Juvenile Idiopathic Arthritis | Drug: CP-690,550 (tofacitinib);Other: placebo | Pfizer | NULL | Completed | 2 Years | 17 Years | All | 225 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Israel;Mexico;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom;Chile;Germany;South Africa;Switzerland |
| 125 | EUCTR2015-003999-79-FI (EUCTR) | 23/05/2016 | 22/04/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP | Juvenile idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | Argentina;Russian Federation;United States;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Finland;Poland;Italy;Mexico;Chile;France;Germany;Estonia | ||
| 126 | EUCTR2015-003999-79-CZ (EUCTR) | 11/05/2016 | 09/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 127 | EUCTR2015-003999-79-ES (EUCTR) | 04/05/2016 | 18/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis MedDRA version: 18.1;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 128 | EUCTR2014-003260-20-NL (EUCTR) | 04/05/2016 | 17/11/2015 | CHAMP Trial: comparing monotherapy and polytherapy treatment strategies in newly diagnosed juvenile idiopathic arthritis. | CHAMP: Children with Arthritis: Monotherapy or Polytherapy. A multicentre, single-blinded, randomized treat to target, one-year follow-up clinical trial in patients with recent onset Juvenile Idiopathic Arthritis (JIA). - CHAMP | Juvenile idiopathic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE Trade Name: sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: SULFASALAZINE Other descriptive name: SULFASALAZINE Trade Name: Hydroxychloroquine Product Name: Hydroxychloroquine INN or Proposed INN: HYDROXYCHLOROQUINE Other descriptive name: HYDROXYCHLOROQUINE | Leiden University Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 4 | Netherlands | ||
| 129 | EUCTR2015-000435-33-GB (EUCTR) | 18/08/2015 | 17/07/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 130 | EUCTR2015-000435-33-BE (EUCTR) | 12/08/2015 | 19/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Spain;Belgium;Russian Federation;Germany;Italy;United Kingdom | ||
| 131 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 132 | EUCTR2015-000435-33-DE (EUCTR) | 07/08/2015 | 10/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 133 | EUCTR2015-000435-33-HU (EUCTR) | 27/07/2015 | 10/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 134 | EUCTR2015-000435-33-PL (EUCTR) | 07/07/2015 | 03/07/2015 | A study to assess the pharmacokinetics and safety of tocilizumab inpatients less than 2 years old with Active Systemic Juvenile IdiopathicArthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Belgium;Spain;Poland;Russian Federation;Germany;Italy;United Kingdom | ||
| 135 | EUCTR2015-001323-23-GB (EUCTR) | 03/07/2015 | 01/05/2015 | A study of Tocilizumab in patients with JIA associated Uveitis who have not responded to treatment with an anti-TNF. | A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis. - APTITUDE | Juvenile Idiopathic Arthritis with Associated Uveitis MedDRA version: 18.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0;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: Tocilizumab Product Name: Tocilizumab Product Code: Ro 487-7533/F10 INN or Proposed INN: Tocilizumab Other descriptive name: RoActemra | University Hospitals Bristol NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 22 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 136 | EUCTR2015-000435-33-ES (EUCTR) | 26/06/2015 | 29/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 137 | NCT02396212 (ClinicalTrials.gov) | May 7, 2015 | 25/2/2015 | Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA | An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis | Biological: Canakinumab | Novartis Pharmaceuticals | NULL | Completed | 2 Years | 19 Years | All | 19 | Phase 3 | Japan |
| 138 | JPRN-JapicCTI-152865 | 01/4/2015 | Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA | An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis | Intervention name : ACZ885 INN of the intervention : Canakinumab Dosage And administration of the intervention : 4mg/kg every 4 weeks Control intervention name : null | Novartis Pharma K.K. | NULL | 2 | 19 | BOTH | 20 | Phase 3 | NULL | ||
| 139 | ChiCTR-OOC-15006228 | 2015-04-01 | 2015-04-09 | Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritis | Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritis | systemic-onset juvenile idiopathic arthritis | disease active group,disease remission group:add heparin into neutrophils in vitro; | Shanghai Children's Medical Center | NULL | Recruiting | 3 | 16 | Both | disease active group,disease remission group:30; | China | |
| 140 | EUCTR2013-004867-29-NL (EUCTR) | 23/12/2014 | 23/09/2014 | Study of efficacy and safety of dose reduction or dose interval prolongation of canakinumab in patients with SJIA | An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885G2306 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 19.1;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 141 | NCT02277444 (ClinicalTrials.gov) | December 17, 2014 | 27/10/2014 | A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy | A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy | Arthritis, Juvenile | Drug: Golimumab;Drug: Methotrexate | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 130 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;Israel;Mexico;Russian Federation;South Africa;Puerto Rico |
| 142 | EUCTR2013-004867-29-DE (EUCTR) | 28/11/2014 | 25/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 19.0;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 143 | NCT02296424 (ClinicalTrials.gov) | November 17, 2014 | 10/10/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis (SJIA) | Drug: ACZ885 150 mg (Canakinumab) | Novartis Pharmaceuticals | NULL | Completed | 2 Years | 20 Years | All | 182 | Phase 3 | United States;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Turkey;Argentina;Hong Kong;Mexico |
| 144 | EUCTR2013-004867-29-BE (EUCTR) | 07/11/2014 | 29/09/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 18.0;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 145 | EUCTR2013-004867-29-HU (EUCTR) | 04/11/2014 | 25/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 18.0;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 146 | NCT02334748 (ClinicalTrials.gov) | November 3, 2014 | 23/12/2014 | A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies | A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) | Systemic Juvenile Idiopathic Arthritis;Hereditary Periodic Fevers | Drug: canakinumab | Novartis Pharmaceuticals | NULL | Completed | 5 Years | 20 Years | All | 31 | Phase 3 | France |
| 147 | EUCTR2013-004867-29-ES (EUCTR) | 20/10/2014 | 06/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 17.0;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: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 148 | EUCTR2013-004867-29-IT (EUCTR) | 03/10/2014 | 26/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 17.0;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 149 | EUCTR2014-002872-95-FR (EUCTR) | 15/09/2014 | 18/06/2015 | A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1 | A French open-label extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who participated in the international phase III study CACZ885G2301E1 - CACZ885GFR01 | Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations MedDRA version: 18.0;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: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma S.A.S | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | France | ||
| 150 | EUCTR2013-004867-29-SE (EUCTR) | 10/09/2014 | 25/07/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 19.0;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 151 | EUCTR2013-004867-29-AT (EUCTR) | 04/09/2014 | 31/07/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA) MedDRA version: 19.0;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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 152 | NCT02165345 (ClinicalTrials.gov) | July 16, 2014 | 13/6/2014 | Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis | Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 2 Years | 18 Years | All | 82 | Phase 1 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom |
| 153 | EUCTR2013-005212-98-IT (EUCTR) | 09/07/2014 | 20/05/2014 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 17.0;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 1 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany | ||
| 154 | EUCTR2013-005212-98-DE (EUCTR) | 30/06/2014 | 19/05/2014 | Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA) 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] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 1 | United States;France;Mexico;Canada;Argentina;Spain;Brazil;Australia;Russian Federation;Germany;United Kingdom;Italy | ||
| 155 | 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 | |||
| 156 | EUCTR2013-005212-98-ES (EUCTR) | 16/06/2014 | 09/06/2014 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 17.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC | Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 1 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany | ||
| 157 | EUCTR2013-005212-98-GB (EUCTR) | 21/05/2014 | 20/05/2014 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA) 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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 104 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 158 | 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 | |||
| 159 | 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 | ||
| 160 | 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 | |||
| 161 | 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 | |||
| 162 | NCT02067962 (ClinicalTrials.gov) | March 5, 2014 | 13/2/2014 | Identification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome Sequencing | Identification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome Sequencing | Arthritis, Juvenile Rheumatoid | Biological: Blood sample | University Hospital, Montpellier | NULL | Completed | 1 Month | 40 Years | All | 30 | N/A | NULL |
| 163 | EUCTR2012-002067-10-NL (EUCTR) | 30/01/2014 | 24/09/2013 | Adult bonemarrow stem cells for treatment of juvenile arthritis in childhood | Mesenchymal stromal cells for treatment of drug resistantpediatric Juvenile idiopathic arthritis - MSC-JIA | juvenile idiopathic arthritis MedDRA version: 17.0;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] | Product Name: Mesenchymal Stromal Cells Product Code: TC-MSC INN or Proposed INN: mesenchymal stromal cells Other descriptive name: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 164 | EUCTR2012-003195-39-IT (EUCTR) | 08/10/2013 | 22/07/2013 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03. | Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) MedDRA version: 14.1;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] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 1mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.7mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.4mL prefilled syringes | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 165 | EUCTR2012-003195-39-BE (EUCTR) | 07/10/2013 | 09/07/2013 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11Site specific Protocol Amendment 13 dated 17-July-2015 | Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) 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] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 1mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.7mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.4mL prefilled syringes | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 166 | NCT02030613 (ClinicalTrials.gov) | October 1, 2013 | 13/8/2013 | Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis | Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Genetic: Blood test | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 4 Years | 17 Years | All | 126 | N/A | France |
| 167 | EUCTR2012-003195-39-ES (EUCTR) | 17/09/2013 | 12/07/2013 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03 | Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) MedDRA version: 16.0;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] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 1mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.7mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.4mL prefilled syringes | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 168 | EUCTR2012-003195-39-DE (EUCTR) | 26/08/2013 | 08/07/2013 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11Site specific Protocol Amendment 13 dated 17-July-2015Site specific Protocol Amendment 12 dated 02-July-2015 | Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) MedDRA version: 18.1;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] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 1mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.7mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.4mL prefilled syringes | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 169 | EUCTR2012-003486-18-PL (EUCTR) | 19/08/2013 | 02/07/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 14.1;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Australia;Peru;Germany | ||
| 170 | NCT01904292 (ClinicalTrials.gov) | August 15, 2013 | 14/6/2013 | A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis | A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 1 Year | 17 Years | All | 52 | Phase 1 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom |
| 171 | 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 | ||
| 172 | EUCTR2012-003486-18-DE (EUCTR) | 08/08/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany;United States;Spain;Russian Federation;United Kingdom;Italy | ||
| 173 | EUCTR2012-003490-26-DE (EUCTR) | 08/08/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 174 | EUCTR2011-004915-22-IT (EUCTR) | 22/07/2013 | 21/09/2012 | A long-term, open label, study for treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FORTREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.0;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] | Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: Tofacitinib | PFIZER INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Hungary;Mexico;Argentina;Poland;Russian Federation;Germany;Italy | |||
| 175 | NCT01904279 (ClinicalTrials.gov) | July 2013 | 14/6/2013 | A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) | A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 1 Year | 17 Years | All | 52 | Phase 1 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom;Peru;Poland |
| 176 | EUCTR2012-003486-18-ES (EUCTR) | 28/06/2013 | 26/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 16.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany | ||
| 177 | NCT01844518 (ClinicalTrials.gov) | June 28, 2013 | 29/4/2013 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | Active Polyarticular Juvenile Idiopathic Arthritis | Biological: Abatacept | Bristol-Myers Squibb | NULL | Active, not recruiting | 2 Years | 17 Years | All | 187 | Phase 3 | United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation;South Africa;Spain |
| 178 | EUCTR2012-003490-26-ES (EUCTR) | 26/06/2013 | 26/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 16.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 179 | EUCTR2012-003490-26-GB (EUCTR) | 14/06/2013 | 20/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 180 | EUCTR2012-003486-18-GB (EUCTR) | 14/06/2013 | 20/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany | ||
| 181 | EUCTR2012-003486-18-IT (EUCTR) | 11/06/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 14.1;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany | ||
| 182 | EUCTR2012-003490-26-IT (EUCTR) | 11/06/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 14.1;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;United Kingdom;Italy | ||
| 183 | NCT01734382 (ClinicalTrials.gov) | June 10, 2013 | 22/11/2012 | A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab) | A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis (SJIA) Who Experience Laboratory Abnormalities During Treatment With Tocilizumab | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 35 | Phase 4 | United States;Argentina;Canada;Germany;Israel;Italy;Mexico;Russian Federation;Spain;United Kingdom;Australia;Norway;Sweden |
| 184 | NCT02024334 (ClinicalTrials.gov) | June 2013 | 10/12/2013 | Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis | Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Leflunomide | Mashhad University of Medical Sciences | NULL | Recruiting | 2 Years | 19 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of |
| 185 | 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 | |||
| 186 | 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 | |||
| 187 | EUCTR2012-003054-92-CZ (EUCTR) | 18/04/2013 | 18/12/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA) | An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;Sweden | |||
| 188 | 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 | |||
| 189 | NCT01500551 (ClinicalTrials.gov) | March 18, 2013 | 22/12/2011 | Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | Juvenile Idiopathic Arthritis | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 2 Years | 18 Years | All | 340 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Chile;Switzerland |
| 190 | NCT01513902 (ClinicalTrials.gov) | March 2013 | 17/1/2012 | Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA) | An Open-label Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Pediatric Patients From 2 To Less Than 18 Years Of Age With Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis | Drug: CP-690,550 | Pfizer | NULL | Completed | 2 Years | 17 Years | All | 26 | Phase 1 | United States;Germany;Poland;Slovakia;Hungary |
| 191 | NCT01727986 (ClinicalTrials.gov) | March 2013 | 8/11/2012 | An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study | Extension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977) | Juvenile Idiopathic Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 9 Years | 18 Years | Both | 11 | Phase 3 | Brazil |
| 192 | EUCTR2012-003054-92-ES (EUCTR) | 28/01/2013 | 21/12/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA) | An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ?-SPECIFIC 4 Patients | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | |||
| 193 | EUCTR2012-003054-92-AT (EUCTR) | 24/01/2013 | 11/12/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA) | An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ILARIS Product Name: Ilaris Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB Trade Name: ILARIS Product Name: Ilaris Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 239 | United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;Sweden | |||
| 194 | EUCTR2012-000444-10-IT (EUCTR) | 22/01/2013 | 11/01/2013 | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) 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: RoActemra INN or Proposed INN: TOCILIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 195 | EUCTR2012-000444-10-DE (EUCTR) | 30/11/2012 | 28/09/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) 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] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 43 | Phase 4 | Sweden;Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom | ||
| 196 | EUCTR2012-000444-10-ES (EUCTR) | 22/11/2012 | 14/09/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 15.0;Level: LLT;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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Mexico;Canada;Spain;Australia;Germany;Norway;Italy;United Kingdom;Sweden | ||
| 197 | EUCTR2011-004914-40-IT (EUCTR) | 14/11/2012 | 21/09/2012 | A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients aged 2-18 | AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THEPHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 INPEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITHJUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.0;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] | Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Hungary;Mexico;Argentina;Poland;Russian Federation;Italy | ||
| 198 | EUCTR2012-000444-10-GB (EUCTR) | 09/11/2012 | 21/08/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) 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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 43 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom;Sweden | ||
| 199 | EUCTR2012-000444-10-SE (EUCTR) | 01/11/2012 | 04/10/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) 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] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 43 | Phase 4 | Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;United Kingdom;Italy;Sweden | ||
| 200 | NCT01455701 (ClinicalTrials.gov) | October 26, 2012 | 18/10/2011 | A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) | A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | N/A | 24 Months | All | 11 | Phase 1 | United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;United Kingdom |
| 201 | EUCTR2011-004914-40-PL (EUCTR) | 19/09/2012 | 16/05/2012 | A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18 | AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS MedDRA version: 17.1;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] | Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy | ||
| 202 | EUCTR2011-004915-22-DE (EUCTR) | 17/09/2012 | 11/06/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden | ||
| 203 | EUCTR2011-004915-22-PL (EUCTR) | 14/09/2012 | 21/05/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Trade Name: XELJANZ Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: Tofacitinib Other descriptive name: APD421 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;South Africa;Germany;Netherlands;China;Sweden | ||
| 204 | EUCTR2011-004914-40-HU (EUCTR) | 03/08/2012 | 17/05/2012 | AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) | AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS MedDRA version: 15.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Poland;Russian Federation;Germany;Italy;Serbia;Czech Republic;Hungary;Slovakia;Mexico;Argentina | ||
| 205 | EUCTR2011-004915-22-HU (EUCTR) | 03/08/2012 | 17/05/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) MedDRA version: 15.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Serbia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Germany;Italy | |||
| 206 | EUCTR2011-004914-40-SK (EUCTR) | 31/07/2012 | 31/07/2012 | A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18 | AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC 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] | Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy | ||
| 207 | 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 | ||
| 208 | NCT01544114 (ClinicalTrials.gov) | April 2012 | 21/2/2012 | A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA) | A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA) | Juvenile Idiopathic Arthritis (JIA) | Drug: VIMOVO 250/20;Drug: VIMOVO 375/20;Drug: VIMOVO 500/20 | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 12 Years | 16 Years | All | 46 | Phase 4 | United States |
| 209 | NCT01575769 (ClinicalTrials.gov) | March 2012 | 10/4/2012 | An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis | Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From Poland and Russia Who Completed the Global, Multinational Trial (WA19977). | Juvenile Idiopathic Arthritis | Drug: RoActemra/Actemra (tocilizumab) | Hoffmann-La Roche | NULL | Terminated | 2 Years | N/A | All | 41 | Phase 3 | Poland;Russian Federation |
| 210 | 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 | ||
| 211 | 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 | |||
| 212 | NCT01673919 (ClinicalTrials.gov) | February 2012 | 23/8/2012 | A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study | Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977) | Juvenile Idiopathic Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 4 Years | N/A | All | 7 | Phase 3 | France |
| 213 | NCT01667471 (ClinicalTrials.gov) | January 2012 | 15/8/2012 | A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study | Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global, Multinational Trial (WA19977) | Juvenile Idiopathic Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 9 Years | 18 Years | All | 6 | Phase 3 | Germany |
| 214 | 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 | ||
| 215 | 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 | ||
| 216 | EUCTR2011-001097-25-DE (EUCTR) | 19/10/2011 | 21/09/2011 | Tocilizumab i.v. monthly in patients with pcJIA | Long-term, interventional, open label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Germany who completed the global, multinational trial (WA19977) | Polyarticular-course juvenile idiopathic 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] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: Ro-Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Pharma AG | NULL | Not Recruiting | Female: no Male: no | Germany | ||||
| 217 | EUCTR2011-003341-18-CZ (EUCTR) | 14/10/2011 | 05/09/2011 | NAP | An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) - - | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 14.1;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] | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl- phenyl carbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride; monohydrate | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 3 | Czech Republic | |||
| 218 | 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 |
| 219 | 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 | ||
| 220 | 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 | ||
| 221 | 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 | 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 | ||
| 222 | 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 | ||
| 223 | 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 | ||
| 224 | 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 | ||
| 225 | 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 | ||
| 226 | 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 | ||
| 227 | EUCTR2010-021141-41-GB (EUCTR) | 24/06/2011 | 30/03/2011 | Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis. - SYCAMORE | Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis. - SYCAMORE | Juvenile Idiopathic Arthritis Associated Uveitis MedDRA version: 14.1;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders | Product Name: Adalimumab (40mg) INN or Proposed INN: Adalimumab Product Name: Adalimumab (20mg) INN or Proposed INN: Adalimumab | University Hospitals Bristol NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 154 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 228 | EUCTR2009-015019-42-DE (EUCTR) | 10/05/2011 | 20/08/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands | |||
| 229 | NCT01358383 (ClinicalTrials.gov) | May 2011 | 16/5/2011 | Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers | A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects | Juvenile Idiopathic Arthritis | Drug: naproxen;Drug: esomeprazole | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 28 | Phase 1 | United States |
| 230 | EUCTR2009-015019-42-BE (EUCTR) | 04/04/2011 | 06/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany | ||
| 231 | 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 | ||||
| 232 | EUCTR2010-019094-15-BE (EUCTR) | 07/12/2010 | 20/05/2010 | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Czech Republic;Slovenia;Spain;Belgium;Italy | ||
| 233 | EUCTR2009-015019-42-FI (EUCTR) | 17/11/2010 | 27/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands | |||
| 234 | EUCTR2009-015019-42-LT (EUCTR) | 02/11/2010 | 17/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 235 | EUCTR2009-015019-42-AT (EUCTR) | 05/10/2010 | 01/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 236 | NCT01261624 (ClinicalTrials.gov) | October 2010 | 15/12/2010 | Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis | A Multicenter, Open Label, Dose Finding Study to Evaluate Efficacy and Safety of Givinostat Administered in Two Different Doses in Patients With Poly JIA Not Adequately Responding to the Standard Treatment. | Polyarticular Course Juvenile Idiopathic Arthritis | Drug: Givinostat | Italfarmaco | NULL | Terminated | 2 Years | 17 Years | All | 16 | Phase 2 | Belgium;Czech Republic;Italy;Romania;Serbia;Slovenia;Spain |
| 237 | EUCTR2010-019094-15-ES (EUCTR) | 06/09/2010 | 26/05/2010 | Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Artritis Idiopática Juvenil de evolución poliarticular (AIJ poli) / Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 238 | EUCTR2010-019094-15-SI (EUCTR) | 17/08/2010 | 22/06/2010 | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 239 | EUCTR2010-019094-15-IT (EUCTR) | 12/07/2010 | 27/05/2010 | A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36 | A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36 | polyarticular course Juvenile Idiopathic Arthritis in ethe following forms: - RF positive and negative polyarthritis - systemic arthritis without systemic features - extended oligoarthritis MedDRA version: 12.1;Level: LLT;Classification code 10036036;Term: Polyarticular JCA | Product Code: Givinostat INN or Proposed INN: Givinostat | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 240 | EUCTR2010-019094-15-CZ (EUCTR) | 01/07/2010 | 17/05/2010 | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 241 | EUCTR2008-008008-42-GR (EUCTR) | 15/06/2010 | 04/12/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 242 | EUCTR2008-005476-27-GR (EUCTR) | 15/06/2010 | 17/12/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 243 | NCT00637780 (ClinicalTrials.gov) | June 2010 | 11/3/2008 | Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis | An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis | Arthritis, Juvenile Rheumatoid | Drug: Sulfasalazine | Pfizer | NULL | Terminated | 6 Years | 17 Years | All | 2 | Phase 4 | United States;Mexico;Canada |
| 244 | 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 | |||
| 245 | 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 | |||
| 246 | 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 | |||
| 247 | 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 | ||
| 248 | EUCTR2008-005479-82-GR (EUCTR) | 20/04/2010 | 04/12/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 249 | 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 | |||
| 250 | 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 | ||
| 251 | EUCTR2008-005476-27-GB (EUCTR) | 08/03/2010 | 11/09/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 252 | 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 | ||
| 253 | NCT04200833 (ClinicalTrials.gov) | March 1, 2010 | 6/8/2019 | Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab | Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab | JIA Associated Uveitis | Drug: Golimumab | Medical University of Graz | NULL | Completed | N/A | N/A | All | 10 | NULL | |
| 254 | 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 | ||
| 255 | EUCTR2009-011593-15-NL (EUCTR) | 09/02/2010 | 30/09/2009 | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | polyarticular-course juvenile idiopathic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 256 | 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 | ||||
| 257 | 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 | |||
| 258 | EUCTR2008-008008-42-AT (EUCTR) | 28/01/2010 | 30/12/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;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: ILARIS Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 259 | 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 | |||
| 260 | 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 | |||
| 261 | EUCTR2008-005479-82-AT (EUCTR) | 17/12/2009 | 02/12/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 262 | EUCTR2008-008008-42-GB (EUCTR) | 16/12/2009 | 11/09/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 263 | EUCTR2008-005479-82-GB (EUCTR) | 16/12/2009 | 11/09/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 264 | 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 | |||
| 265 | 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 | ||
| 266 | 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 | |||
| 267 | 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 | ||
| 268 | NCT00988221 (ClinicalTrials.gov) | November 30, 2009 | 1/10/2009 | A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis | A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 188 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Netherlands |
| 269 | EUCTR2008-008008-42-DE (EUCTR) | 24/11/2009 | 17/04/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859 | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Denmark;Peru;Netherlands;Germany;Norway;Sweden | |||
| 270 | EUCTR2008-005476-27-DE (EUCTR) | 24/11/2009 | 17/04/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 271 | EUCTR2008-005479-82-DE (EUCTR) | 24/11/2009 | 17/04/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 272 | EUCTR2009-011593-15-FR (EUCTR) | 12/11/2009 | 04/12/2009 | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | polyarticular-course juvenile idiopathic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 273 | EUCTR2008-008008-42-DK (EUCTR) | 10/11/2009 | 30/09/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Hungary;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 274 | EUCTR2008-008008-42-NL (EUCTR) | 05/11/2009 | 25/05/2009 | research with children with severe reuma | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 16.0;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: ILARIS Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Germany;Netherlands;Sweden | |||
| 275 | EUCTR2008-005476-27-DK (EUCTR) | 28/10/2009 | 28/09/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Sweden | |||
| 276 | EUCTR2008-005479-82-DK (EUCTR) | 28/10/2009 | 30/09/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 277 | EUCTR2009-011593-15-ES (EUCTR) | 27/10/2009 | 29/07/2009 | Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | Artritis idiopática juvenil activa de curso poliarticular/Polyarticular-course juvenile idiopathic arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 3 | France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 278 | EUCTR2009-011593-15-BE (EUCTR) | 19/10/2009 | 23/09/2009 | A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;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: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 3 | Canada;Argentina;Belgium;Poland;Brazil;Peru;Australia;Netherlands;Germany;Mexico;United States;Spain;Russian Federation;Italy;United Kingdom;France | ||
| 279 | 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 | |||
| 280 | 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 | ||||
| 281 | 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 | ||||
| 282 | EUCTR2009-011593-15-IT (EUCTR) | 11/09/2009 | 28/07/2009 | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - ND | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - ND | Polyarticular-course JIA (pcJIA) consisting of RF-positive, RF-negative, and extended oligoarticular subsets. MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: RoActemra Trade Name: RoActemra Trade Name: RoActemra | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | France;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy | |||
| 283 | 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 | ||
| 284 | EUCTR2009-011593-15-DE (EUCTR) | 08/09/2009 | 20/07/2009 | A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;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: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;Peru;Germany;Netherlands | |||
| 285 | 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 |
| 286 | NCT00807846 (ClinicalTrials.gov) | September 2009 | 10/12/2008 | A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects | A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis. | Arthritis, Juvenile Rheumatoid | Drug: Celecoxib;Drug: Naproxen | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 2 Years | 17 Years | All | 201 | Phase 4 | United States;Chile;Costa Rica;Peru;Philippines;Russian Federation;Serbia;South Africa;Switzerland;Ukraine |
| 287 | EUCTR2009-011593-15-GB (EUCTR) | 20/08/2009 | 06/07/2009 | A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;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: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany | ||
| 288 | 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 | |||
| 289 | EUCTR2008-005479-82-IT (EUCTR) | 20/07/2009 | 05/08/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: ILARIS | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 290 | EUCTR2008-005479-82-SE (EUCTR) | 16/07/2009 | 16/06/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 291 | EUCTR2008-005476-27-SE (EUCTR) | 16/07/2009 | 18/06/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 292 | EUCTR2008-008008-42-SE (EUCTR) | 16/07/2009 | 16/06/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 16.0;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] | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Swaziland;Canada;Argentina;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 293 | 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 |
| 294 | EUCTR2008-003280-40-NL (EUCTR) | 30/06/2009 | 23/02/2009 | Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed children | Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed children | The effectiveness of Ambirix will be investigated in 2 groups:1) children with hiv-infection, with CD4 counts > 15%2) children with a rheumatic disease for which immune-suppressive medication is used. MedDRA version: 9.1;Level: LLT;Classification code 10002725;Term: Anti-HIV positive MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: Ambirix Trade Name: Ambirix | Public Health Service Amsterdam | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 295 | EUCTR2008-005476-27-IT (EUCTR) | 22/06/2009 | 05/08/2009 | A randomized, double-blind, placebo controlled, singledose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND | A randomized, double-blind, placebo controlled, singledose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Name: canakinumab Product Code: ACZ885G INN or Proposed INN: ILARIS | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 296 | EUCTR2008-008008-42-IT (EUCTR) | 22/06/2009 | 05/08/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: canakinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 297 | EUCTR2008-008008-42-ES (EUCTR) | 12/06/2009 | 01/04/2009 | Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1 | Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1 | Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 298 | EUCTR2008-005479-82-ES (EUCTR) | 12/06/2009 | 05/03/2009 | Estudio doble ciego, randomizado, controlado con placebo, con diseño de retirada en la prevención de brotes con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301 | Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas. MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 299 | EUCTR2008-005479-82-BE (EUCTR) | 04/06/2009 | 14/04/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Spain;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 300 | EUCTR2008-008008-42-BE (EUCTR) | 04/06/2009 | 09/04/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) 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: Ilaris Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 301 | EUCTR2008-005476-27-BE (EUCTR) | 04/06/2009 | 27/04/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 302 | EUCTR2008-005476-27-ES (EUCTR) | 14/05/2009 | 03/03/2009 | Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305 | Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305 | Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas. MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 303 | EUCTR2008-005479-82-FR (EUCTR) | 07/05/2009 | 19/03/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 304 | EUCTR2008-008008-42-FR (EUCTR) | 07/05/2009 | 19/03/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 305 | EUCTR2008-005476-27-FR (EUCTR) | 07/05/2009 | 19/03/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 306 | EUCTR2008-008008-42-HU (EUCTR) | 05/05/2009 | 07/04/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 16.0;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: ILARIS Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 307 | EUCTR2008-005479-82-HU (EUCTR) | 05/05/2009 | 06/04/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 308 | EUCTR2008-005476-27-HU (EUCTR) | 04/05/2009 | 07/04/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 309 | NCT00688545 (ClinicalTrials.gov) | April 2009 | 29/5/2008 | Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis | SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs | Arthritis, Juvenile Rheumatoid | Drug: Celecoxib;Drug: nsNSAIDs | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Terminated | 2 Years | 17 Years | All | 275 | United States | |
| 310 | NCT00775437 (ClinicalTrials.gov) | March 2009 | 17/10/2008 | Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use | 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 | Drug: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 2 Years | 4 Years | All | 32 | Phase 3 | Czech Republic;Denmark;France;Germany;Puerto Rico;Slovakia;Sweden;United States |
| 311 | EUCTR2008-008169-36-NL (EUCTR) | 17/02/2009 | 29/12/2008 | Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study | Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study | Juvenile Idiopathic ArthritisSystemic lupus erythematosus childhood dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis MedDRA version: 9.1;Classification code 10008521;Term: Childhood dermatomyositis | Trade Name: Cervarix suspensie voor injectie Product Name: not applicable Product Code: not applicable | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: no | Netherlands | ||||
| 312 | EUCTR2006-006812-31-DE (EUCTR) | 03/12/2008 | 25/06/2008 | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects | Other descriptive name: METHOTREXATE DISODIUM Trade Name: metoject | University of Munster | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Netherlands;Germany | ||
| 313 | EUCTR2007-000872-18-NL (EUCTR) | 01/12/2008 | 06/03/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA, Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 314 | EUCTR2008-006741-70-IT (EUCTR) | 16/10/2008 | 17/03/2009 | Comparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial - ND | Comparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial - ND | juvenile idiopatic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
| 315 | EUCTR2007-000872-18-CZ (EUCTR) | 16/10/2008 | 26/02/2008 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 17.0;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: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden | |||
| 316 | EUCTR2007-000872-18-GB (EUCTR) | 03/10/2008 | 26/08/2009 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 13.1;Level: LLT;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: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden | ||
| 317 | JPRN-UMIN000001457 | 2008/10/01 | 28/10/2008 | The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial | The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial - Efficacy assessment of tocilizumab to steroid-resistant patients with adult Still's disease | Adult Still's disease and systemic juvenile idiopathic arthritis | Tocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weight | Division of Rheumatology & Clinical Immunology, Jichi Medical University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 318 | EUCTR2007-000872-18-GR (EUCTR) | 09/09/2008 | 21/03/2008 | A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab | A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab Other descriptive name: MRA (Actemra) | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Norway;Germany;United Kingdom;Italy;Sweden | ||
| 319 | EUCTR2007-000872-18-DE (EUCTR) | 11/07/2008 | 14/02/2008 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | Systemic Juvenile Idiopathic Arthritis (sJIA) 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] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Norway;Sweden | |||
| 320 | JPRN-UMIN000001250 | 2008/07/01 | 16/07/2008 | Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial | Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial - Effects of tocilizumab-addition to steroid-dependent patients with adult Still's disease | Adult Still's disease or systemic juvenile idiopathic arthritis | Tocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks. | Division of Rheumatology & Clinical Immunology, Jichi Medical University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 321 | EUCTR2007-000872-18-DK (EUCTR) | 27/06/2008 | 05/03/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA Other descriptive name: Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 322 | EUCTR2007-000872-18-SK (EUCTR) | 09/06/2008 | 09/04/2008 | A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 323 | EUCTR2007-000872-18-ES (EUCTR) | 23/05/2008 | 26/02/2008 | Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER | Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER | Artritis idiopatica juvenil sistémica (sJIA)Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 324 | EUCTR2007-000872-18-IT (EUCTR) | 12/05/2008 | 23/03/2009 | A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND | A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Name: ACTEMRA Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 325 | NCT00642460 (ClinicalTrials.gov) | May 2008 | 19/3/2008 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA) | A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab | Juvenile Idiopathic Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroids | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 112 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France |
| 326 | EUCTR2007-000872-18-BE (EUCTR) | 15/04/2008 | 29/01/2008 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 13.1;Level: LLT;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: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden | |||
| 327 | EUCTR2007-000872-18-SE (EUCTR) | 07/04/2008 | 05/02/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA, Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 328 | EUCTR2007-001861-14-NL (EUCTR) | 07/02/2008 | 29/02/2008 | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine - safety and efficacy of MMR vaccination in JIA patients | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine - safety and efficacy of MMR vaccination in JIA patients | Juvenile Idiopathic Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Bof-, Mazelen-, Rubellavaccin, poeder voor injectievloeistof Trade Name: M-M-RVAXPRO | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 329 | NCT02196480 (ClinicalTrials.gov) | January 2008 | 16/7/2014 | 23-valent Polysaccharide Pneumococcal Vaccine in Juvenile Idiopathic Arthritis Patients Under Anti-TNF Therapy | Short and Long-term Immunogenicity and Safety Following the 23-valent Polysaccharide Pneumococcal Vaccine in Juvenile Idiopathic Arthritis Patients Under Anti-TNF Therapy | Juvenile Idiopathic Arthritis | Biological: anti-TNF | University of Sao Paulo | NULL | Completed | 5 Years | 18 Years | Both | 27 | Phase 4 | Brazil |
| 330 | 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 | ||
| 331 | EUCTR2006-006812-31-NL (EUCTR) | 04/06/2007 | 27/06/2007 | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects | Other descriptive name: METHOTREXATE DISODIUM Trade Name: metoject | university medical centre utrecht | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Germany;Netherlands | ||
| 332 | EUCTR2006-001834-42-GB (EUCTR) | 27/04/2007 | 14/10/2010 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885A2203 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885A2203 | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 8.1;Level: PT;Classification code 10059177;Term: Juvenile arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 26 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Italy;United Kingdom | ||
| 333 | EUCTR2006-001834-42-FR (EUCTR) | 17/04/2007 | 05/10/2006 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 8.1;Level: PT;Classification code 10059177;Term: Juvenile arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 26 | France;United Kingdom;Italy | |||
| 334 | NCT00426218 (ClinicalTrials.gov) | December 2006 | 23/1/2007 | Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Arthritis, Juvenile Rheumatoid | Drug: ACZ885 | Novartis | NULL | Completed | 4 Years | 20 Years | Both | 26 | Phase 1/Phase 2 | Italy |
| 335 | EUCTR2006-001834-42-IT (EUCTR) | 13/10/2006 | 09/01/2007 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203 | Sistemic Juvenile Idiopathic Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Code: ACZ885 Product Code: ACZ885 Product Code: ACZ885 | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;France;Italy | ||||
| 336 | EUCTR2006-000089-35-IT (EUCTR) | 17/08/2006 | 30/08/2006 | Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND | Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND | systemic onset juvenile idiopathic arthritis Level: PTClassification code 10059177 | Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 337 | NCT00570661 (ClinicalTrials.gov) | August 2006 | 10/12/2007 | Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) | Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) | Active Systemic;Onset Juvenile Idiopathic Arthritis | Drug: ITF2357 | Italfarmaco | NULL | Completed | 2 Years | 25 Years | Both | 17 | Phase 2 | Serbia;Former Serbia and Montenegro |
| 338 | NCT00415935 (ClinicalTrials.gov) | July 2006 | 22/12/2006 | PRINTO (the Paediatric Rheumatology International Trials Organisation) | Juvenile Idiopathic Arthritis | Drug: methotrexate | Institute of Child Health | NULL | Recruiting | N/A | 16 Years | Both | N/A | United Kingdom | ||
| 339 | NCT00339157 (ClinicalTrials.gov) | June 2006 | 16/6/2006 | Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS | ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS) | Systemic-Onset Juvenile Idiopathic Arthritis | Drug: Anakinra;Biological: Pneumo23 | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Completed | 2 Years | 20 Years | Both | 24 | Phase 2/Phase 3 | France |
| 340 | EUCTR2005-003129-23-GB (EUCTR) | 18/04/2006 | 24/02/2006 | To prevent and treat osteoporosis in children with rhuematic diseases taking steroids | Prevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS | Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) Vasculitis;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Risedronate Sodium Product Code: 35mg Other descriptive name: RISEDRONATE SODIUM Product Name: Risedronate Sodium Product Code: 5mg Other descriptive name: RISEDRONATE SODIUM Trade Name: One-Alpha drops Product Name: One Alpha Drops Product Code: alfacalcidol 2 micrograms/ml INN or Proposed INN: ALFACALCIDOL Other descriptive name: drops | Belfast Health and Social Care Trust, Musgrave Park Hospital | NULL | Not Recruiting | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 341 | NCT01803321 (ClinicalTrials.gov) | November 2005 | 28/2/2013 | Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) | A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis | Drug: rilonacept (IL-1 Trap);Other: Placebo | Regeneron Pharmaceuticals | NULL | Completed | 4 Years | 20 Years | Both | 24 | Phase 1 | United States |
| 342 | EUCTR2005-004008-36-IT (EUCTR) | 27/10/2005 | 30/01/2012 | Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis | Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis | CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KINERET*SC 7SIR 100MG 0,67ML INN or Proposed INN: Anakinra | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 343 | EUCTR2005-001086-34-ES (EUCTR) | 21/10/2005 | 20/06/2005 | A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patiebts with juvenile idiopathic arthritis in clinical remission.Ensayo aleatorizado de retirada de Metotrexate a los 6 meses versus a los 12 meses, en pacientes con Artritis Idiopática Juvenil (AIJ) en remisión clínica - MTX withdrawal study | A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patiebts with juvenile idiopathic arthritis in clinical remission.Ensayo aleatorizado de retirada de Metotrexate a los 6 meses versus a los 12 meses, en pacientes con Artritis Idiopática Juvenil (AIJ) en remisión clínica - MTX withdrawal study | The present study was designed for the follow up of two groups of patients with JIA, in whom remission was achieved using MTX. In group 1 treatment with MTX will be discontinued as early as 6 months after documentation of remission on medication. In group 2 treatment with MTX will be discontinued later than 12 mpnths after documentation of remission on medication. | Trade Name: Metotrexato Product Name: Methotrexate Trade Name: Methotrexate Product Name: Methotrexate Product Code: L01BA01 | Istituto Giannina Gaslini-PRINTO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Denmark;Spain;Italy | |||
| 344 | EUCTR2005-001086-34-DK (EUCTR) | 21/09/2005 | 19/08/2005 | A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clincal remission - MTX withdrawal study | A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clincal remission - MTX withdrawal study | The present study was designed for the follow up of two groups of patients with JIA, in whom remission was achieved using MTX. In group 1 treatment with MTX will be discontinued as early as 6 months after documentation of remission on medication. In group 2 treatment with MTX will be discontinued later than 12 months after documentation of remission on medication | Product Name: Methotrexate Product Code: L01BA01 Product Name: Methotrexate Product Code: L01BA01 | ISTITUTO GIANNINA GASLINI-PRINTO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Denmark;Spain;Italy | |||
| 345 | EUCTR2005-001086-34-IT (EUCTR) | 13/06/2005 | 01/07/2005 | A randomised Phase III trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clinical remission | A randomised Phase III trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clinical remission | juvenile idiopathic arthritis MedDRA version: 6.1;Level: PT;Classification code 10059177 | Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Denmark;Spain;Italy | |||
| 346 | NCT00144625 (ClinicalTrials.gov) | February 2005 | 2/9/2005 | Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) | An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP | Polyarticular Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 19 | Phase 3 | NULL |
| 347 | EUCTR2004-004153-25-GB (EUCTR) | 10/12/2004 | 17/02/2005 | Effect of recombinant growth hormone on growth and chondrocyte dynamics in children with juvenile idiopathic arthritis (JIA) and growth failure. - rhGH in JIA | Effect of recombinant growth hormone on growth and chondrocyte dynamics in children with juvenile idiopathic arthritis (JIA) and growth failure. - rhGH in JIA | Growth retardation secondary to juvenile idiopathic arthritis | Trade Name: Norditropin SimpleXx 5mg/1.5ml Product Name: Norditropin SimpleXx INN or Proposed INN: Somatropin Other descriptive name: Growth Hormone | Royal Hospital For Sick Children, Yorkhill Division | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 348 | NCT00144664 (ClinicalTrials.gov) | November 2004 | 2/9/2005 | Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) | An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA | Systemic Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 19 | Phase 3 | NULL |
| 349 | NCT00144612 (ClinicalTrials.gov) | July 2004 | 2/9/2005 | Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP | Systemic Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 60 | Phase 3 | NULL |
| 350 | NCT00144599 (ClinicalTrials.gov) | May 2004 | 2/9/2005 | Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) | A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA | Systemic Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab);Drug: placebo | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 56 | Phase 3 | NULL |
| 351 | 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 | |
| 352 | NCT00048542 (ClinicalTrials.gov) | September 2002 | 1/11/2002 | Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis | Arthritis, Juvenile Idiopathic | Biological: Double-Blind Adalimumab/Placebo + MTX;Biological: Double-Blind Adalimumab/Placebo;Drug: OLE BSA Adalimumab +/- MTX;Drug: OLE FD Adalimumab +/- MTX | Abbott | NULL | Completed | 4 Years | 17 Years | All | 171 | Phase 3 | United States;Belgium;Czech Republic;France;Germany;Italy;Slovakia;Spain |
| 353 | NCT02784808 (ClinicalTrials.gov) | January 2000 | 25/5/2016 | Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs) | Juvenile Idiopathic Arthritis | Drug: Biological DMARDs;Drug: Non-Biologic DMARDs | Hoffmann-La Roche | NULL | Completed | N/A | 18 Years | Both | 4557 | N/A | NULL | |
| 354 | NCT00404482 (ClinicalTrials.gov) | January 1991 | 27/11/2006 | Cyclosporine A in the Treatment of Juvenile Idiopathic Arthritis (JIA) Associated Chronic Anterior Uveitis | Efficacy and Adverse Effects of Cyclosporine A in the Treatment of Chronic Anterior Uveitis in Patients With Juvenile Idiopathic Arthritis | Uveitis;Juvenile Idiopathic Arthritis | Drug: Cyclosporine A | St. Franziskus Hospital | NULL | Completed | N/A | 16 Years | Both | 60 | N/A | Germany |
| 355 | EUCTR2007-000872-18-NO (EUCTR) | 20/02/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab. | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: Actemra, MRA | F. Hoffmann-La Roche Limited | NULL | NA | Female: yes Male: yes | 108 | Phase 3 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 356 | EUCTR2021-001577-24-SE (EUCTR) | 22/11/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 357 | EUCTR2015-003999-79-Outside-EU/EEA (EUCTR) | 08/04/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis MedDRA version: 18.1;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | NA | Female: yes Male: yes | 36 | Spain;United Kingdom;United States;Argentina;Canada;Chile;Czech Republic;Estonia;Finland;France;Germany;Italy;Mexico;Netherlands;Poland;Russian Federation | ||||
| 358 | EUCTR2018-001571-21-NL (EUCTR) | 23/05/2018 | Reducing side effects from methotrexate in juvenile arthritis treatment | Training immune functions through pharmacotherapeutic conditioning injuvenile idiopathic arthritis - OPTI-MISS | Juvenile Idiopathic Arthritis;Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02] | Trade Name: Methotrexate Product Name: Methotrexate | Leiden University | NULL | NA | Female: yes Male: yes | 132 | Phase 4 | Netherlands | |||
| 359 | 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 | |||
| 360 | EUCTR2021-001577-24-BE (EUCTR) | 27/10/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics of emapalumab in children and adults with macrophage activation syndrome (MAS) | A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still’s disease) or with MAS in Systemic Lupus Erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic Juvenile Idiopathic Arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic Lupus Erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden | |||
| 361 | EUCTR2008-005479-82-NO (EUCTR) | 12/03/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 362 | 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 | |||
| 363 | EUCTR2017-004495-60-BE (EUCTR) | 14/08/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 103 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | |||
| 364 | EUCTR2019-002788-88-PL (EUCTR) | 28/01/2022 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Poland;Austria;Netherlands;Italy | |||
| 365 | 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 | ||||
| 366 | EUCTR2008-005476-27-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with SystemicJuvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) 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: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 84 | Argentina;Brazil;Israel;Peru;Switzerland;Turkey;United States | ||||
| 367 | EUCTR2014-003737-26-Outside-EU/EEA (EUCTR) | 07/04/2015 | A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritis | A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritis | Juvenile idiopathic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Celebrex INN or Proposed INN: Celecoxib Other descriptive name: CELECOXIB INN or Proposed INN: Celecoxib Other descriptive name: CELECOXIB Product Name: Naproxen INN or Proposed INN: NAPROXEN SODIUM | Pfizer Inc | NULL | NA | Female: yes Male: yes | 201 | Phase 4 | South Africa;Ukraine;United States;Chile;Costa Rica;Peru;Philippines;Russian Federation;Serbia | |||
| 368 | EUCTR2014-004103-73-Outside-EU/EEA (EUCTR) | 12/03/2015 | Safety and Efficacy Study of the long-term administration of TNR-001 in Subjects with Juvenile Idiopathic Arthritis (JIA) | A long-term, open-label study of TNR-001 in Japanese Juvenile Idiopathic Arthritis Subjects. | Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Enbrel | Wyeth Kabushiki Kaisha (Wyeth K.K.) | NULL | NA | Female: yes Male: yes | 32 | Japan | ||||
| 369 | EUCTR2014-004105-32-Outside-EU/EEA (EUCTR) | 01/04/2015 | Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With Chronic Juvenile Arthritis (CJA) Treated by Corticosteroid Therapy | Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor (Genotonorm) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-Term Corticosteroid Therapy. Extension of the Study Beyond Three Years. | Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Pfizer Inc | NULL | NA | Female: yes Male: yes | 21 | France | ||||
| 370 | EUCTR2017-002018-29-BE (EUCTR) | 07/10/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. 235 East 42nd Street, New York, New York 10017 | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden | |||
| 371 | EUCTR2018-002521-30-PL (EUCTR) | 29/05/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 63 | Phase 3 | United States;Belgium;Spain;Poland;Turkey;Russian Federation;South Africa;Germany;Italy | |||
| 372 | EUCTR2015-003999-79-EE (EUCTR) | 14/04/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis MedDRA version: 19.0;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | NA | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | |||
| 373 | EUCTR2012-003490-26-Outside-EU/EEA (EUCTR) | 22/08/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 14.1;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 48 | Phase 1 | Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico | |||
| 374 | EUCTR2017-002018-29-SE (EUCTR) | 18/06/2021 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 Product Name: Tofacitinibe citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden | |||
| 375 | 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 | ||||
| 376 | EUCTR2009-015019-42-Outside-EU/EEA (EUCTR) | 08/03/2012 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 170 | Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico | ||||
| 377 | EUCTR2016-003643-10-NL (EUCTR) | 14/09/2017 | A study to investigate the safety of additional treatment with Vitamin B3 in children with Juvenile Idiopathic Arthritis (JIA) | Modulating regulatory T cell function in JIA with Vitamin B3 (nicotinamide) treatment - B-Vit in JIA | Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: nicotinamide Product Code: 98-92-0 | UMC Utrecht | NULL | NA | Female: yes Male: yes | Phase 1;Phase 2 | Netherlands | ||||
| 378 | EUCTR2017-004471-31-AT (EUCTR) | 08/05/2019 | A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA) | A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 236 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Germany;China;Japan | |||
| 379 | EUCTR2011-004915-22-SE (EUCTR) | 24/06/2021 | A Long-Term, Open-Label, Study for Treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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: XELJANZ Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate Product Code: CP-690-550-10 (DMID D1600180) INN or Proposed INN: Tofacitinib Other descriptive name: APD421 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;China;Sweden | |||
| 380 | JPRN-JapicCTI-050017 | 02/09/2005 | Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA) | Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA) | sJIA | Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion | Chugai Pharmaceutical Co., Ltd. | NULL | 2 | 19 | Phase 3 | NULL | ||||
| 381 | EUCTR2014-004104-30-Outside-EU/EEA (EUCTR) | 01/04/2015 | Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety | Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety | Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Pharmacia & Upjohn S.A. | NULL | NA | Female: yes Male: yes | 30 | France | ||||
| 382 | EUCTR2015-004000-35-CZ (EUCTR) | 13/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Bulgaria;Germany;Netherlands | |||
| 383 | EUCTR2021-001577-24-FR (EUCTR) | 27/08/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 384 | EUCTR2015-003999-79-FR (EUCTR) | 21/06/2018 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic 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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | NA | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | |||
| 385 | EUCTR2016-000940-32-Outside-EU/EEA (EUCTR) | 28/04/2016 | Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan | A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents with Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response orIntolerance to Methotrexate or Biologics. | Juvenile Idiopathic Arthritis MedDRA version: 19.0;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] | Product Name: ABATACEPT Product Code: BMS-188667 INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | NA | Female: yes Male: yes | 23 | Phase 3 | Japan | |||
| 386 | EUCTR2008-005479-82-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) 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: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 177 | Argentina;Brazil;Canada;Israel;Peru;Switzerland;Turkey;United States | ||||
| 387 | EUCTR2012-003195-39-Outside-EU/EEA (EUCTR) | 14/11/2013 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11 | Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) MedDRA version: 17.1;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] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 1mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.7mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.4mL prefilled syringes | Bristol-Myers Squibb International Corporation | NULL | NA | Female: yes Male: yes | 210 | Phase 3 | South Africa;Spain;United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation | |||
| 388 | EUCTR2019-002788-88-BE (EUCTR) | 15/12/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | Belgium;Austria;Netherlands | |||
| 389 | EUCTR2021-001577-24-IT (EUCTR) | 16/09/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Profilassi per Herpes Zoster Product Code: [Profilassi per Herpes Zoster] INN or Proposed INN: Antivirale ad uso diretto | Swedish Orphan Biovitrum AG | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 390 | EUCTR2012-003054-92-BE (EUCTR) | 26/11/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA) | An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Peru;Netherlands;Germany;Sweden | |||
| 391 | EUCTR2013-005212-98-FR (EUCTR) | 17/06/2015 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 18.0;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 96 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany | |||
| 392 | EUCTR2012-000444-10-NO (EUCTR) | 27/09/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 14.1;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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 393 | EUCTR2008-008008-42-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) 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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis PharmaServices AG | NULL | NA | Female: yes Male: yes | 200 | Peru;Russian Federation;South Africa;Switzerland;Turkey;United States;Argentina;Brazil;Canada;Israel | ||||
| 394 | EUCTR2008-008008-42-NO (EUCTR) | 10/03/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 88 | Phase 3 | Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 395 | EUCTR2016-003761-26-IT (EUCTR) | 10/11/2020 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis - Secukinumab safety and efficacy in JPsA and ERA | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 1 SIRINGA PRERIEMPITA Product Name: NA Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy | |||
| 396 | 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 | ||||
| 397 | EUCTR2012-003195-39-FR (EUCTR) | 29/09/2015 | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) | A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03 | Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) MedDRA version: 18.0;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] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 1mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.7mL prefilled syringes Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: 0.4mL prefilled syringes | Bristol-Myers Squibb International Corporation | NULL | NA | Female: yes Male: yes | 210 | Phase 3 | United States;France;Mexico;Argentina;Brazil;Belgium;Spain;Peru;Russian Federation;South Africa;Germany;Italy | |||
| 398 | 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 | |||
| 399 | EUCTR2021-001577-24-NL (EUCTR) | 21/04/2022 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile idiopathic arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden | |||
| 400 | 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 | |||
| 401 | EUCTR2015-000435-33-FR (EUCTR) | 24/07/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;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: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 10 | Phase 1 | United States;France;Hungary;Canada;Argentina;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | |||
| 402 | EUCTR2008-005476-27-NO (EUCTR) | 09/03/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 403 | EUCTR2017-004495-60-DE (EUCTR) | 01/08/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 103 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan | |||
| 404 | EUCTR2015-004000-35-FR (EUCTR) | 22/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis MedDRA version: 19.0;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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | |||
| 405 | EUCTR2015-003999-79-GB (EUCTR) | 01/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP | Juvenile idiopathic 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | NA | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | |||
| 406 | EUCTR2021-001577-24-CZ (EUCTR) | 18/10/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 407 | EUCTR2017-004495-60-AT (EUCTR) | 05/08/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Denmark;Germany;China;Japan | |||
| 408 | 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 | |||
| 409 | 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 | ||||
| 410 | EUCTR2018-002521-30-BE (EUCTR) | 09/07/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 63 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy | |||
| 411 | EUCTR2016-004223-23-FR (EUCTR) | 13/02/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB Other descriptive name: Fully human anti-interferon gamma monoclonal antibody | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | United States;France;Canada;Spain;Netherlands;Italy;United Kingdom | |||
| 412 | EUCTR2012-003486-18-Outside-EU/EEA (EUCTR) | 22/08/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 14.1;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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | NA | Female: yes Male: yes | 48 | Phase 1 | Peru;Poland;Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy | |||
| 413 | EUCTR2017-004495-60-CZ (EUCTR) | 02/09/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Other descriptive name: 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 | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China |