41. 巨細胞性動脈炎 ［臨床試験数：46，薬物数：77（DrugBank：31），標的遺伝子数：32，標的パスウェイ数：118］
Searched query = "Giant cell arteritis", "Temporal arteritis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03892785 | October 2019 | 26 August 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 | Not recruiting | 50 Years | N/A | All | 200 | Phase 3 | France | |
| 2 | NCT03812302 | September 9, 2019 | 30 September 2019 | Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA) | Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.) | Giant Cell Arteritis | Diagnostic Test: 68-Ga HA-DOTATATE PET/CT | University of Alberta | Recruiting | 50 Years | N/A | All | 15 | Phase 2 | Canada | |
| 3 | NCT04012905 | September 2019 | 22 July 2019 | A Randomized, Controled, Open Label Trial: Comparison Between Two Standardised Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell Arteritis | A Randomized, Controled, Open Label Trial: Comparison Between Two Standardised Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell Arteritis | Giant Cell Arteritis | Drug: Corticosteroids for Systemic Use | University Hospital, Caen | University Hospital, Lille;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Central Hospital, Valenciennes;Central Hospital, Lisieux | Not recruiting | 50 Years | N/A | All | 150 | Phase 3 | |
| 4 | NCT03923738 | August 5, 2019 | 11 November 2019 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA). | A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab | Hoffmann-La Roche | Recruiting | 50 Years | N/A | All | 25 | Phase 1 | Switzerland | |
| 5 | NCT03656627 | June 27, 2019 | 22 October 2019 | 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 |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2018-002826-22-FR | 07/03/2019 | 30 April 2019 | 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 Pharmaceutical Form: Solution for injection Trade Name: RoActemra Pharmaceutical Form: Solution for injection in pre-filled syringe | CHU Dijon Bourgogne | Authorised | Female: no Male: no | 200 | Phase 3 | France | |||
| 7 | NCT03841734 | March 2019 | 25 February 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 | Not recruiting | 50 Years | N/A | All | 8 | Phase 3 | France | |
| 8 | EUCTR2018-004072-35-FR | 13/02/2019 | 30 April 2019 | 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 Pharmaceutical Form: Film-coated tablet | CHU de Nice | Authorised | Female: yes Male: yes | 8 | Phase 3 | France | |||
| 9 | NCT03482479 | February 4, 2019 | 22 October 2019 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States | |
| 10 | NCT03765788 | January 30, 2019 | 26 August 2019 | 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 | Recruiting | 50 Years | N/A | All | 50 | Phase 2 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03725202 | January 24, 2019 | 4 November 2019 | A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants 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 | Giant Cell Arteritis (GCA) | Drug: Upadacitinib;Drug: Corticosteroid (CS);Other: Placebo | AbbVie | Recruiting | 50 Years | N/A | All | 420 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Netherlands;New Zealand;Norway;Portugal;Romania;Russian Federation;Spain;Sweden;Switzerland;United Kingdom | |
| 12 | NCT03711448 | January 7, 2019 | 28 October 2019 | 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 | Recruiting | 50 Years | N/A | All | 19 | Phase 2 | France | |
| 13 | EUCTR2017-002988-18-DK | 04/01/2019 | 28 February 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 ® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SARILUMAB Current Sponsor code: SAR153191 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Kevzara ® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SARILUMAB Current Sponsor code: SAR153191 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Cortancyl ® 5 mg Pharmaceutical Form: Capsule INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Cortancyl ® 1 mg Pharmaceutical Form: Capsule INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Cortancyl ® 20 mg | Sanofi-Aventis Recherche & Développement | Authorised | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | |||
| 14 | NCT03827018 | December 21, 2018 | 2 September 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. | Recruiting | 50 Years | 85 Years | All | 60 | Phase 2 | United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom | |
| 15 | EUCTR2018-000344-25-FR | 18/12/2018 | 28 February 2019 | Essai, randomisé, contrôlé, ouvert, de deux schémas standardisés de décroissance, respectivement rapide (nord-américain) et lent (européen), de cortisone dans l’artérite à cellules géantes. | Essai, randomisé, contrôlé, ouvert, de deux schémas standardisés de décroissance, respectivement rapide (nord-américain) et lent (européen), de cortisone dans l’artérite à cellules géantes. - CORTODOSE | Patients atteints d’artérite à cellules géantes 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: CORTANCYL Product Name: CORTANCYL Pharmaceutical Form: Tablet | CHU CAEN | Authorised | Female: yes Male: yes | 150 | Phase 3 | France | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2018-002610-12-DE | 06/12/2018 | 7 January 2019 | 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] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Other descriptive name: SECUKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Novartis Pharma GmbH | Authorised | Female: yes Male: yes | 50 | Phase 2 | Germany | |||
| 17 | NCT03745586 | December 1, 2018 | 28 January 2019 | 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 | Recruiting | 50 Years | N/A | All | 18 | Phase 1/Phase 2 | Italy;Switzerland | |
| 18 | NCT03726749 | November 28, 2018 | 10 December 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 |
| 19 | NCT03600805 | November 20, 2018 | 11 November 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 | Drug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placebo | Sanofi | Regeneron Pharmaceuticals | Recruiting | 50 Years | N/A | All | 360 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom |
| 20 | EUCTR2018-001003-36-EE | 09/07/2018 | 28 February 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 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: MAVRILIMUMAB CAS Number: 1085337-57-0 Current Sponsor code: KPL-301 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A Pharmaceutical Form: Tablet | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | Authorised | 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 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03313102 | November 16, 2017 | 18 June 2018 | Study of T Lymphocytes in Patients With Horton Disease | Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells | Horton Disease | Biological: blood samples | Centre Hospitalier Universitaire Dijon | Recruiting | 51 Years | N/A | All | 60 | N/A | France | |
| 22 | NCT03202368 | October 25, 2017 | 22 October 2019 | An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA) | 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 | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 50 Years | N/A | All | 3 | Phase 3 | France | |
| 23 | NCT03192969 | July 15, 2017 | 16 December 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 | Not recruiting | 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 | |
| 24 | NCT03026504 | March 9, 2017 | 26 November 2018 | Baricitinib in Relapsing Giant Cell Arteritis | Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study | Arteritis, Giant Cell | Drug: Baricitinib | Matthew J Koster | Eli Lilly and Company | Recruiting | 50 Years | N/A | All | 15 | Phase 2 | United States |
| 25 | NCT02955147 | December 1, 2016 | 26 August 2019 | 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 | Not recruiting | 50 Years | N/A | All | 20 | Phase 1/Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT02902731 | November 2016 | 26 September 2016 | Giant Cell Arteritis and Anakinra Trial | Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis | Giant Cell Arteritis | Drug: PLACEBO;Drug: ANAKINRA | University Hospital, Caen | Hôpital Claude-Huriez;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Valenciennes Hospital, Valenciennes, FRANCE | Not recruiting | 51 Years | N/A | Both | 70 | Phase 3 | |
| 27 | EUCTR2015-005804-27-FR | 04/06/2016 | 12 March 2018 | GiAnT (Giant cell arteritis and Anakinra Trial) | Essai randomisé, contrôlé, en double aveugle, de l'anakinra contre placebo, en adjonction à la corticothérapie dans l'artérite à cellules géantes. - GiAnT | Patients atteints d’artérite à cellules géantes (ou maladie de Horton) MedDRA version: 18.1 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: KINERET Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | CHU CAEN | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | France | |||
| 28 | EUCTR2015-001758-14-DE | 18/12/2015 | 11 December 2017 | 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: 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 Pharmaceutical Form: Injection INN or Proposed INN: Sirukumab Current Sponsor code: GSK2973327 Other descriptive name: CNTO 136 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use Product Name: Sirukumab Product Code: GSK2973327 Pharmaceutical Form: Injection INN or Proposed INN: Sirukumab Current Sponsor code: GSK2973327 Other descriptive name: CNTO 136 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use Trade Name: Prednisone Capsules Product Name: Prednisone Pharmaceutical Form: Capsule INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Prednisone Capsules Product Name: Prednisone Pharmaceutical Form: Capsule INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Prednisone Capsules Product Name: Prednisone Pharmaceutical Form: Capsule INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | GlaxoSmithKline Research and Development Limited | 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 | NCT02531633 | October 16, 2015 | 18 December 2018 | 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 | Not recruiting | 50 Years | N/A | All | 161 | Phase 2/Phase 3 | United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom | |
| 30 | NCT02857192 | October 2015 | 15 August 2016 | Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease | Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease) | Horton's Disease | Biological: Blood samples | Centre Hospitalier Universitaire Dijon | Recruiting | 51 Years | N/A | Both | 40 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03244709 | January 1, 2015 | 16 December 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 | Recruiting | 18 Years | 90 Years | All | 15 | Phase 4 | Italy | |
| 32 | NCT03285945 | October 2014 | 16 December 2017 | 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: PET10;Drug: PET3 | University of Aarhus | Not recruiting | 50 Years | N/A | All | 24 | N/A | Denmark | |
| 33 | EUCTR2013-002778-38-ES | 14/01/2014 | 16 November 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: 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: gevokizumab CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name: XOMA 052 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | 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 | |||
| 34 | NCT01910038 | November 8, 2013 | 16 December 2017 | 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 | Not recruiting | 50 Years | N/A | All | 20 | Phase 2 | France | |
| 35 | NCT01791153 | July 22, 2013 | 16 December 2017 | 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 | Not recruiting | 50 Years | N/A | All | 251 | Phase 3 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2011-006022-25-GB | 23/05/2013 | 28 February 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Pharmaceutical Form: Capsule Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Pharmaceutical Form: Capsule Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Pharmaceutical Form: Capsule Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 37 | JPRN-UMIN000008812 | 2012/10/01 | 2 April 2019 | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) | Rheumatoid arthritis | tocilizumab monotherapy | Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity | Not Recruiting | 16years-old | 80years-old | Male and Female | 40 | Not selected | Japan | ||
| 38 | NCT01450137 | September 2011 | 6 October 2015 | Tocilizumab for Patients With Giant Cell Arteritis | A Phase II, Randomized, Double-blind, Placebo Controlled Study of Tocilizumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab + Glucocorticoids (GCs);Drug: Placebo + Glucocorticoids (GCs) | University Hospital Inselspital, Berne | University of Bern;Roche Pharma AG | Not recruiting | 50 Years | N/A | Both | 30 | Phase 2 | Switzerland |
| 39 | NCT01400464 | July 2009 | 19 February 2015 | 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 | Not recruiting | 50 Years | N/A | Both | 150 | Phase 4 | France | |
| 40 | NCT00556439 | December 2008 | 4 January 2016 | Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis | Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu's Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis | Takayasu's Arteritis;Giant Cell Arteritis | Drug: Abatacept;Drug: Placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | The Cleveland Clinic;Office of Rare Diseases (ORD);Rare Diseases Clinical Research Network | Not recruiting | 15 Years | N/A | Both | 98 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT00305539 | May 2006 | 19 February 2015 | 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 | Not recruiting | 50 Years | N/A | Both | 69 | Phase 3 | France |
| 42 | NCT00076726 | November 2003 | 19 February 2015 | A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis | A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Infliximab | Centocor, Inc. | The Cleveland Clinic | Not recruiting | 50 Years | N/A | Both | 44 | Phase 2 | United States;Belgium;Italy;Spain;United Kingdom |
| 43 | NCT00430807 | January 2002 | 19 October 2015 | Hydroxychloroquine in Giant Cell Arteritis | Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis. | Giant Cell Arteritis | Drug: hydroxychloroquine/placebo | University Hospital, Toulouse | Not recruiting | 18 Years | 85 Years | Both | 75 | Phase 3 | France | |
| 44 | NCT00138983 | May 2000 | 19 February 2015 | 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 | Not recruiting | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 45 | NCT00006055 | March 2000 | 19 February 2015 | 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 | Not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT00004686 | February 1994 | 7 April 2015 | 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 | Not recruiting | 50 Years | N/A | Both | 300 | Phase 2 |