41. 巨細胞性動脈炎 Giant cell arteritis Clinical trials / Disease details
臨床試験数 : 128 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 124
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-002528-18-DK (EUCTR) | 22/02/2022 | 30/07/2021 | RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency. | RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency; A multicentre, randomised, double blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis receiving ongoing low-dose prednisolone treatment. - RESCUE | Glucocorticoid-induced adrenal insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10001369;Term: Adrenal insufficiency NOS;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Hydrokortison orion Product Name: hydrokortison Product Code: H02AB09 INN or Proposed INN: hydrocortisone Other descriptive name: HYDROCORTISONE | Copenhagen University Hospital Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 4 | Denmark | ||
| 2 | NCT04474847 (ClinicalTrials.gov) | March 15, 2021 | 13/7/2020 | Abatacept for the Treatment of Giant Cell Arteritis | A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART) | Giant Cell Arteritis | Drug: Abatacept;Drug: Placebo | University of Pennsylvania | NULL | Recruiting | 50 Years | N/A | All | 78 | Phase 3 | United States |
| 3 | EUCTR2020-000622-26-DE (EUCTR) | 22/01/2021 | 17/09/2020 | A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects 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 - THEIA | 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: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Poland;Belgium;Israel;Germany;Italy | ||
| 4 | EUCTR2020-000622-26-IT (EUCTR) | 18/12/2020 | 24/05/2021 | A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects 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 - THEIA | 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] - Virus Diseases [C02] | Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Germany;Italy | ||
| 5 | NCT04633447 (ClinicalTrials.gov) | December 10, 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 | Recruiting | 50 Years | N/A | All | 60 | Phase 2 | United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain |
| 6 | NCT04239196 (ClinicalTrials.gov) | July 1, 2020 | 19/11/2019 | Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA | Open Label Phase II Randomized Non-comparative Study of SC Tocilizumab Associated With IV Pulse Steroid Versus IV Pulse Steroid Alone for the Treatment of Acute Anterior Ischemic Optic Neuropathy Associated With Giant Cell Arteritis | Giant Cell Arteritis;Optic Ischaemic Neuropathy | Drug: tocilizumab and IV steroids combination;Other: IV steroids combination alone | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Roche Chugai | Not yet recruiting | 50 Years | N/A | All | 58 | Phase 2 | France |
| 7 | 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 |
| 8 | EUCTR2018-001003-36-HR (EUCTR) | 10/04/2019 | 17/05/2019 | 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 | ||
| 9 | EUCTR2018-002826-22-FR (EUCTR) | 07/03/2019 | 21/11/2018 | MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA | MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA | 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: METOJECT Trade Name: RoActemra | CHU Dijon Bourgogne | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 10 | NCT03841734 (ClinicalTrials.gov) | March 2019 | 5/2/2019 | Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | Arteritis, Giant Cell;Blindness and Low Vision | Drug: treatment | Centre Hospitalier Universitaire de Nice | NULL | Not yet recruiting | 50 Years | N/A | All | 8 | Phase 3 | France |
| 11 | 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 | ||
| 12 | EUCTR2018-004072-35-FR (EUCTR) | 13/02/2019 | 06/11/2018 | Study of the value of early treatment in patients with sudden blindness | Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO | giant cell arteritis MedDRA version: 20.0;Level: PT;Classification code 10003232;Term: Arteritis coronary;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: BOSENTAN MYLAN Product Name: BOSENTAN MYLAN | CHU de Nice | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 13 | 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 |
| 14 | 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 | ||
| 15 | NCT03745586 (ClinicalTrials.gov) | December 1, 2018 | 6/11/2018 | Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab | Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Glucocorticoids | University Hospital Inselspital, Berne | NULL | Completed | 50 Years | N/A | All | 18 | Phase 1/Phase 2 | Switzerland;Italy |
| 16 | EUCTR2018-001003-36-IT (EUCTR) | 30/11/2018 | 11/10/2018 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 17 | EUCTR2018-001003-36-BE (EUCTR) | 28/11/2018 | 16/08/2018 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 18 | EUCTR2018-001003-36-NL (EUCTR) | 13/11/2018 | 29/06/2018 | 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: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;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 | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Netherlands;Germany;New Zealand | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | NCT03192969 (ClinicalTrials.gov) | July 15, 2017 | 14/6/2017 | A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA) | A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Abatacept;Other: Placebo;Drug: Glucocorticoid Treatment | Bristol-Myers Squibb | NULL | Withdrawn | 50 Years | N/A | All | 0 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Denmark;Estonia;France;Germany;Greece;Ireland;Italy;Netherlands;Poland;Romania;Serbia;Spain;Sweden;Switzerland;United Kingdom |
| 23 | 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 |
| 24 | EUCTR2015-001758-14-IT (EUCTR) | 08/06/2016 | 20/01/2021 | A study to assess the efficacy and safety of Sirukumab in the treatment ofpatients with Giant Cell Arteritis, using multiple sites, and an untreatedpatient 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 - NA | Giant Cell Arteritis (GCA) MedDRA version: 20.0;Level: SOC;Classification code 10047065;Term: Vascular disorders;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 Trade Name: Capsule di prednisone INN or Proposed INN: PREDNISONE Trade Name: Prednisone Capsule INN or Proposed INN: PREDNISONE Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone capsule INN or Proposed INN: PREDNISONE Other descriptive name: Prednisone | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 25 | 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 | ||
| 26 | EUCTR2015-001758-14-NL (EUCTR) | 04/02/2016 | 26/08/2015 | 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 of Sirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.1;Level: SOC;Classification code 10047065;Term: Vascular disorders;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 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 |
| 31 | 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 | ||
| 32 | 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 | |||
| 33 | 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 | |||
| 34 | 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 | |||
| 35 | 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 | |||
| 36 | 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 | |||
| 37 | 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 | |||
| 38 | NCT03285945 (ClinicalTrials.gov) | October 2014 | 12/10/2016 | FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment | Fluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity? | Giant Cell Arteritis | Drug: PET3;Drug: PET10 | University of Aarhus | NULL | Completed | 50 Years | N/A | All | 24 | N/A | Denmark |
| 39 | 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 | ||
| 40 | 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 | ||
| 41 | 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 | |||
| 42 | 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 | ||
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | EUCTR2011-006022-25-PT (EUCTR) | 07/06/2013 | 22/05/2013 | 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: 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 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 49 | 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 | ||
| 50 | EUCTR2011-006022-25-GB (EUCTR) | 23/05/2013 | 15/05/2013 | 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: 19.0;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 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 51 | EUCTR2011-006022-25-SE (EUCTR) | 16/05/2013 | 07/05/2013 | 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: 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 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 52 | 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 | ||
| 53 | NCT00305539 (ClinicalTrials.gov) | May 2006 | 21/3/2006 | HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis | HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis | Giant Cell Arteritis | Drug: adalimumab;Drug: placebo | Assistance Publique - Hôpitaux de Paris | Abbott | Completed | 50 Years | N/A | Both | 69 | Phase 3 | France |
| 54 | 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 |