41. 巨細胞性動脈炎
［臨床試験数：108，薬物数：111（DrugBank：32），標的遺伝子数：33，標的パスウェイ数：121］
Searched query = "Giant cell arteritis", "Temporal arteritis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT04633447 (ClinicalTrials.gov) | December 1, 2020 | 6/11/2020 | A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis | A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis | Giant Cell Arteritis | Drug: Guselkumab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Not yet recruiting | 50 Years | N/A | All | 60 | Phase 2 | United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain |
| 2 | EUCTR2019-003964-30-GB (EUCTR) | 22/10/2020 | 31/07/2020 | Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children. | Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS) | Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab | Cambridge University Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | United Kingdom | ||
| 3 | NCT03892785 (ClinicalTrials.gov) | January 27, 2020 | 26/3/2019 | MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | Giant Cell Arteritis | Drug: Prednisone treatment;Drug: Tocilizumab treatment;Drug: Methotrexate treatment;Other: Questionnaires;Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 50 Years | N/A | All | 200 | Phase 3 | France |
| 4 | EUCTR2017-002988-18-FI (EUCTR) | 02/10/2019 | 12/09/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;Serbia;United States;Estonia;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Slovenia;Finland;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Croatia;Germany;Norway;Sweden | ||
| 5 | EUCTR2017-003978-13-DK (EUCTR) | 17/09/2019 | 25/02/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Denmark;Australia;Netherlands;Germany;Japan;New Zealand | ||
| 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 |
| 6 | EUCTR2017-003978-13-FR (EUCTR) | 22/08/2019 | 19/04/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolone 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 7 | EUCTR2017-003978-13-GR (EUCTR) | 26/07/2019 | 18/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: SELECT GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular 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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 8 | EUCTR2017-003978-13-PT (EUCTR) | 08/07/2019 | 14/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 9 | NCT03656627 (ClinicalTrials.gov) | June 27, 2019 | 31/8/2018 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 72 | Phase 1 | United States |
| 10 | EUCTR2017-003978-13-AT (EUCTR) | 15/05/2019 | 05/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 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 |
| 11 | EUCTR2017-003978-13-BE (EUCTR) | 15/05/2019 | 01/05/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular 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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 12 | EUCTR2017-003978-13-DE (EUCTR) | 14/05/2019 | 05/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular 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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 13 | EUCTR2017-003978-13-HU (EUCTR) | 08/05/2019 | 25/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;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 Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 14 | EUCTR2017-002988-18-HR (EUCTR) | 15/04/2019 | 17/05/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 15 | EUCTR2018-001003-36-DE (EUCTR) | 27/02/2019 | 21/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 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 |
| 16 | EUCTR2017-002988-18-AT (EUCTR) | 19/02/2019 | 28/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 17 | NCT03765788 (ClinicalTrials.gov) | January 30, 2019 | 3/12/2018 | A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis | A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN) | Giant Cell Arteritis | Biological: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo to match Secukinumab, s.c. | Novartis Pharmaceuticals | NULL | Active, not recruiting | 50 Years | N/A | All | 52 | Phase 2 | Germany |
| 18 | NCT03711448 (ClinicalTrials.gov) | January 7, 2019 | 15/10/2018 | Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | Patients Relapsing Refractory Giant Cell Arteritis | Drug: prednisone treatment;Drug: prednisone and ustekinumab treatment;Other: questionnaires;Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 50 Years | N/A | All | 38 | Phase 2 | France |
| 19 | NCT03827018 (ClinicalTrials.gov) | December 21, 2018 | 25/1/2019 | KPL-301 for Subjects With Giant Cell Arteritis | A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis | Giant Cell Arteritis | Combination Product: mavrilimumab;Combination Product: placebo | Kiniksa Pharmaceuticals, Ltd. | NULL | Active, not recruiting | 50 Years | 85 Years | All | 70 | Phase 2 | United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom |
| 20 | EUCTR2017-002988-18-NL (EUCTR) | 10/12/2018 | 01/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 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 |
| 21 | EUCTR2017-002988-18-BE (EUCTR) | 07/12/2018 | 06/03/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 22 | EUCTR2018-001003-36-GB (EUCTR) | 06/12/2018 | 20/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: Prednisone Tablets, USP Product Code: N/A INN or Proposed INN: n/a Other descriptive name: PREDNISONE | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 23 | EUCTR2018-002610-12-DE (EUCTR) | 06/12/2018 | 23/08/2018 | Study in patients with giant cell arteritis to assess efficacy of secukinumab compared to placebo | A randomized, parallel-group, double-blind, placebo-controlled, multicenter phase 2 trial to investigate the safety and efficacy of secukinumab (AIN457) in patients with giant cell arteritis (TitAIN) - TitAIN | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Germany | |||
| 24 | NCT03726749 (ClinicalTrials.gov) | November 28, 2018 | 30/10/2018 | Tocilizumab Plus a Short Prednisone Taper for GCA | Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA) | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone | Massachusetts General Hospital | Roche-Genentech | Recruiting | 50 Years | N/A | All | 30 | Phase 4 | United States |
| 25 | EUCTR2017-002988-18-DE (EUCTR) | 26/11/2018 | 26/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 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 |
| 26 | NCT03600805 (ClinicalTrials.gov) | November 20, 2018 | 17/7/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placebo | Sanofi | Regeneron Pharmaceuticals | Suspended | 50 Years | N/A | All | 360 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;Denmark;Estonia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom |
| 27 | EUCTR2017-002988-18-HU (EUCTR) | 19/11/2018 | 04/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 28 | EUCTR2017-002988-18-ES (EUCTR) | 19/10/2018 | 25/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 29 | EUCTR2017-002988-18-SE (EUCTR) | 18/10/2018 | 11/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 30 | EUCTR2017-002988-18-EE (EUCTR) | 18/10/2018 | 15/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 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 |
| 31 | EUCTR2018-001003-36-SI (EUCTR) | 03/10/2018 | 30/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 32 | EUCTR2018-001003-36-ES (EUCTR) | 08/08/2018 | 28/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 33 | EUCTR2018-001003-36-EE (EUCTR) | 09/07/2018 | 11/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 34 | EUCTR2016-002716-41-FR (EUCTR) | 24/05/2017 | 04/04/2017 | A STUDY TO EVALUATE LONG TERM SAFETY OF TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE | AN EXTENSION STUDY TO EVALUATE LONG TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE, AND SUBSEQUENTLY HAVING FLARE OR PERSISTING DISEASE ACTIVITY | Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra 162 mg solution for injection in pre-filled syringe INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | ROCHE SAS | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 3 | France | ||
| 35 | NCT02985424 (ClinicalTrials.gov) | May 2017 | 1/12/2016 | Polymyalgia Rheumatica and Giant Cell Arteritis | Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol | Polymyalgia Rheumatica;Giant Cell Arteritis | Other: 18F-FDG PET/CT | Svendborg Hospital | Odense University Hospital | Not yet recruiting | 18 Years | 95 Years | All | 80 | N/A | Denmark |
| 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 |
| 36 | NCT02955147 (ClinicalTrials.gov) | December 1, 2016 | 31/10/2016 | Ustekinumab for the Treatment of Giant Cell Arteritis | Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis;Temporal Arteritis;Horton's Disease | Drug: Ustekinumab;Drug: Prednisone | Massachusetts General Hospital | NULL | Terminated | 50 Years | N/A | All | 13 | Phase 1;Phase 2 | United States |
| 37 | EUCTR2015-001758-14-HU (EUCTR) | 15/04/2016 | 19/01/2016 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 20.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Encorton Product Name: Encorton INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 38 | EUCTR2015-001758-14-BG (EUCTR) | 08/01/2016 | 21/10/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 39 | EUCTR2015-001758-14-DE (EUCTR) | 18/12/2015 | 15/07/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.1;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 40 | EUCTR2015-001758-14-BE (EUCTR) | 14/12/2015 | 05/02/2016 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 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 |
| 41 | NCT02531633 (ClinicalTrials.gov) | October 16, 2015 | 6/7/2015 | Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sirukumab;Drug: Placebo to match sirukumab;Drug: Prednisone;Drug: Placebo to match prednisone | GlaxoSmithKline | NULL | Terminated | 50 Years | N/A | All | 161 | Phase 3 | United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom |
| 42 | EUCTR2015-001758-14-ES (EUCTR) | 30/09/2015 | 31/07/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 43 | EUCTR2013-002778-38-EE (EUCTR) | 12/02/2015 | 13/01/2015 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway | |||
| 44 | EUCTR2013-002778-38-FI (EUCTR) | 04/02/2015 | 14/10/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: Gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Norway | |||
| 45 | EUCTR2013-002778-38-BE (EUCTR) | 21/01/2015 | 09/12/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway | |||
| 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 |
| 46 | EUCTR2013-002778-38-IE (EUCTR) | 19/01/2015 | 09/01/2015 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway | |||
| 47 | NCT03244709 (ClinicalTrials.gov) | January 1, 2015 | 1/8/2017 | Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission. | Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission: a Prospective, Pilot Study. | Giant Cell Arteritis | Drug: Tocilizumab | Hospital of Prato | NULL | Recruiting | 18 Years | 90 Years | All | 15 | Phase 4 | Italy |
| 48 | EUCTR2013-002778-38-AT (EUCTR) | 18/12/2014 | 10/12/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway | |||
| 49 | EUCTR2013-002778-38-DK (EUCTR) | 18/12/2014 | 09/12/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Norway | |||
| 50 | EUCTR2013-002778-38-GB (EUCTR) | 29/07/2014 | 29/10/2013 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway | ||
| 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 |
| 51 | EUCTR2013-002778-38-CZ (EUCTR) | 12/02/2014 | 06/01/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway | ||
| 52 | EUCTR2013-002778-38-ES (EUCTR) | 14/01/2014 | 18/10/2013 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Laboratorios Servier SL | Institut de Recherches Internationales Servier ( IRIS ) | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Czech Republic;Canada;Finland;Belgium;Spain;Ireland;Austria;Denmark;Australia;Russian Federation;United Kingdom | |||
| 53 | EUCTR2013-002778-38-IT (EUCTR) | 11/11/2013 | 02/10/2013 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Denmark | ||
| 54 | NCT01910038 (ClinicalTrials.gov) | November 8, 2013 | 17/7/2013 | Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. | Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. | Giant Cell Arteritis | Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks | Centre Hospitalier Universitaire Dijon | NULL | Completed | 50 Years | N/A | All | 20 | Phase 2 | France |
| 55 | EUCTR2011-006022-25-NL (EUCTR) | 09/10/2013 | 24/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: TOCILIZUMAB SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 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 |
| 56 | EUCTR2011-006022-25-BE (EUCTR) | 30/09/2013 | 17/06/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 57 | EUCTR2011-006022-25-PL (EUCTR) | 09/09/2013 | 16/07/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 58 | NCT01791153 (ClinicalTrials.gov) | July 22, 2013 | 12/2/2013 | An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) | A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 251 | Phase 3 | United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria |
| 59 | EUCTR2011-006022-25-ES (EUCTR) | 24/06/2013 | 10/06/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 60 | EUCTR2011-006022-25-DK (EUCTR) | 14/06/2013 | 14/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden;United States;Spain;Portugal | ||
| 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 |
| 61 | EUCTR2011-006022-25-DE (EUCTR) | 06/06/2013 | 13/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 62 | EUCTR2011-006022-25-AT (EUCTR) | 14/05/2013 | 10/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 17.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 63 | EUCTR2011-006022-25-IT (EUCTR) | 05/05/2013 | 07/03/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;Italy;United Kingdom;France;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 64 | EUCTR2011-005090-22-GB (EUCTR) | 28/02/2012 | 17/01/2012 | A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis | A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA | Giant Cell Arteritis MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Lodotra Product Name: Lodotra (delayed release prednisolone) INN or Proposed INN: Prednisolone Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione | Southend Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 65 | NCT01400464 (ClinicalTrials.gov) | July 2009 | 21/7/2011 | Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | Giant Cell Arteritis | Drug: Prednisone therapy and pharmacokinetic | University Hospital, Caen | NULL | Active, not recruiting | 50 Years | N/A | Both | 150 | Phase 4 | France |
| 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 |
| 66 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 67 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | |
| 68 | NCT00004686 (ClinicalTrials.gov) | February 1994 | 24/2/2000 | Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis | Giant Cell Arteritis | Drug: methotrexate;Drug: prednisone | The Cleveland Clinic | NULL | Completed | 50 Years | N/A | Both | 300 | Phase 2 | NULL |