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 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.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
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PhaseCountries
1NCT03892785October 201926 August 2019MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled TrialMEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled TrialGiant Cell ArteritisDrug: Prednisone treatment;Drug: Tocilizumab treatment;Drug: Methotrexate treatment;Other: Questionnaires;Biological: Blood samplesCentre Hospitalier Universitaire DijonNot recruiting50 YearsN/AAll200Phase 3France
2NCT03812302September 9, 201930 September 2019Use 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 ArteritisDiagnostic Test: 68-Ga HA-DOTATATE PET/CTUniversity of AlbertaRecruiting50 YearsN/AAll15Phase 2Canada
3NCT04012905September 201922 July 2019A Randomized, Controled, Open Label Trial: Comparison Between Two Standardised Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell ArteritisA Randomized, Controled, Open Label Trial: Comparison Between Two Standardised Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell ArteritisGiant Cell ArteritisDrug: Corticosteroids for Systemic UseUniversity Hospital, CaenUniversity Hospital, Lille;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Central Hospital, Valenciennes;Central Hospital, LisieuxNot recruiting50 YearsN/AAll150Phase 3
4NCT03923738August 5, 201911 November 2019A 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 ArteritisGiant Cell ArteritisDrug: TocilizumabHoffmann-La RocheRecruiting50 YearsN/AAll25Phase 1Switzerland
5NCT03656627June 27, 201922 October 2019Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbRecruiting18 YearsN/AAll72Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-002826-22-FR07/03/201930 April 2019MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIAMEthotrexate 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 BourgogneAuthorised Female: no
Male: no
200Phase 3France
7NCT03841734March 201925 February 2019Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBOStudy of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBOArteritis, Giant Cell;Blindness and Low VisionDrug: treatmentCentre Hospitalier Universitaire de NiceNot recruiting50 YearsN/AAll8Phase 3France
8EUCTR2018-004072-35-FR13/02/201930 April 2019Study of the value of early treatment in patients with sudden blindnessStudy of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBOgiant 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 NiceAuthorised Female: yes
Male: yes
8Phase 3France
9NCT03482479February 4, 201922 October 2019Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaRecruiting18 YearsN/AAll60Phase 2United States
10NCT03765788January 30, 201926 August 2019A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell ArteritisA 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 ArteritisBiological: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo to match Secukinumab, s.c.Novartis PharmaceuticalsRecruiting50 YearsN/AAll50Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
11NCT03725202January 24, 20194 November 2019A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell ArteritisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell ArteritisGiant Cell Arteritis (GCA)Drug: Upadacitinib;Drug: Corticosteroid (CS);Other: PlaceboAbbVieRecruiting50 YearsN/AAll420Phase 3United 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
12NCT03711448January 7, 201928 October 2019Ustekinumab for the Treatment of Relapse of Refractory Giant Cell ArteritisUstekinumab for the Treatment of Relapse of Refractory Giant Cell ArteritisPatients Relapsing Refractory Giant Cell ArteritisDrug: prednisone treatment;Drug: prednisone and ustekinumab treatment;Other: questionnaires;Biological: Blood samplesCentre Hospitalier Universitaire DijonRecruiting50 YearsN/AAll19Phase 2France
13EUCTR2017-002988-18-DK04/01/201928 February 2019Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritisGiant 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 & DéveloppementAuthorised Female: yes
Male: yes
508Phase 3Portugal;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
14NCT03827018December 21, 20182 September 2019KPL-301 for Subjects With Giant Cell ArteritisA Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell ArteritisGiant Cell ArteritisCombination Product: mavrilimumab;Combination Product: placeboKiniksa Pharmaceuticals, Ltd.Recruiting50 Years85 YearsAll60Phase 2United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom
15EUCTR2018-000344-25-FR18/12/201828 February 2019Essai, 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. - CORTODOSEPatients 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 CAENAuthorised Female: yes
Male: yes
150Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-002610-12-DE06/12/20187 January 2019Study in patients with giant cell arteritis to assess efficacy of secukinumab compared to placeboA 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) - TitAINGiant 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 GmbHAuthorisedFemale: yes
Male: yes
50Phase 2Germany
17NCT03745586December 1, 201828 January 2019Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and TocilizumabGiant Cell Arteritis Treatment With Ultra-short Glucocorticoids and TocilizumabGiant Cell ArteritisDrug: Tocilizumab;Drug: GlucocorticoidsUniversity Hospital Inselspital, BerneRecruiting50 YearsN/AAll18Phase 1/Phase 2Italy;Switzerland
18NCT03726749November 28, 201810 December 2018Tocilizumab Plus a Short Prednisone Taper for GCATocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA)Giant Cell ArteritisDrug: Tocilizumab;Drug: PrednisoneMassachusetts General HospitalRoche-GenentechRecruiting50 YearsN/AAll30Phase 4United States
19NCT03600805November 20, 201811 November 2019Evaluation of Efficacy and Safety of Sarilumab in Patients With GCAA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell ArteritisGiant Cell ArteritisDrug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placeboSanofiRegeneron PharmaceuticalsRecruiting50 YearsN/AAll360Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom
20EUCTR2018-001003-36-EE09/07/201828 February 2019A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritisgiant 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
60Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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Inclusion_
agemin
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PhaseCountries
21NCT03313102November 16, 201718 June 2018Study of T Lymphocytes in Patients With Horton DiseaseStudy of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T CellsHorton DiseaseBiological: blood samplesCentre Hospitalier Universitaire DijonRecruiting51 YearsN/AAll60N/AFrance
22NCT03202368October 25, 201722 October 2019An 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 ArteritisDrug: TocilizumabHoffmann-La RocheNot recruiting50 YearsN/AAll3Phase 3France
23NCT03192969July 15, 201716 December 2017A 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 ArteritisGiant Cell ArteritisDrug: Abatacept;Other: Placebo;Drug: Glucocorticoid TreatmentBristol-Myers SquibbNot recruiting50 YearsN/AAll0Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Denmark;Estonia;France;Germany;Greece;Ireland;Italy;Netherlands;Poland;Romania;Serbia;Spain;Sweden;Switzerland;United Kingdom
24NCT03026504March 9, 201726 November 2018Baricitinib in Relapsing Giant Cell ArteritisBaricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot StudyArteritis, Giant CellDrug: BaricitinibMatthew J KosterEli Lilly and CompanyRecruiting50 YearsN/AAll15Phase 2United States
25NCT02955147December 1, 201626 August 2019Ustekinumab for the Treatment of Giant Cell ArteritisOpen Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell ArteritisGiant Cell Arteritis;Temporal Arteritis;Horton's DiseaseDrug: Ustekinumab;Drug: PrednisoneMassachusetts General HospitalNot recruiting50 YearsN/AAll20Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02902731November 201626 September 2016Giant Cell Arteritis and Anakinra TrialRandomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell ArteritisGiant Cell ArteritisDrug: PLACEBO;Drug: ANAKINRAUniversity Hospital, CaenHôpital Claude-Huriez;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Valenciennes Hospital, Valenciennes, FRANCENot recruiting51 YearsN/ABoth70Phase 3
27EUCTR2015-005804-27-FR04/06/201612 March 2018GiAnT (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. - GiAnTPatients 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 CAENNot RecruitingFemale: yes
Male: yes
70Phase 3France
28EUCTR2015-001758-14-DE18/12/201511 December 2017A 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 groupA 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 ApplicableGiant 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 LimitedNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
29NCT02531633October 16, 201518 December 2018Efficacy and Safety Study of Sirukumab in Patients With Giant Cell ArteritisA 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 ArteritisGiant Cell ArteritisDrug: Sirukumab;Drug: Placebo to match sirukumab;Drug: Prednisone;Drug: Placebo to match prednisoneGlaxoSmithKlineNot recruiting50 YearsN/AAll161Phase 2/Phase 3United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom
30NCT02857192October 201515 August 2016Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's DiseaseStudy of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)Horton's DiseaseBiological: Blood samplesCentre Hospitalier Universitaire DijonRecruiting51 YearsN/ABoth40N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
31NCT03244709January 1, 201516 December 2017Tocilizumab 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 ArteritisDrug: TocilizumabHospital of PratoRecruiting18 Years90 YearsAll15Phase 4Italy
32NCT03285945October 201416 December 2017FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid TreatmentFluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity?Giant Cell ArteritisDrug: PET10;Drug: PET3University of AarhusNot recruiting50 YearsN/AAll24N/ADenmark
33EUCTR2013-002778-38-ES14/01/201416 November 2015A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisGiant 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 SLInstitut de Recherches Internationales Servier ( IRIS )Not RecruitingFemale: yes
Male: yes
50Estonia;Czech Republic;Canada;Finland;Belgium;Spain;Ireland;Austria;Denmark;Australia;Russian Federation;United Kingdom
34NCT01910038November 8, 201316 December 2017Evaluation 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 ArteritisDrug: corticoids+ tocilizumab 8mg/Kg/4 weeksCentre Hospitalier Universitaire DijonNot recruiting50 YearsN/AAll20Phase 2France
35NCT01791153July 22, 201316 December 2017An 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 ArteritisGiant Cell ArteritisDrug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: MethotrexateHoffmann-La RocheNot recruiting50 YearsN/AAll251Phase 3United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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gender
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size
PhaseCountries
36EUCTR2011-006022-25-GB23/05/201328 February 2019A 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 ARTERITISGiant 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 LtdNot Recruiting Female: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
37JPRN-UMIN0000088122012/10/012 April 2019Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical UniversitityNot Recruiting16years-old80years-oldMale and Female40Not selectedJapan
38NCT01450137September 20116 October 2015Tocilizumab for Patients With Giant Cell ArteritisA Phase II, Randomized, Double-blind, Placebo Controlled Study of Tocilizumab in Patients With Giant Cell ArteritisGiant Cell ArteritisDrug: Tocilizumab + Glucocorticoids (GCs);Drug: Placebo + Glucocorticoids (GCs)University Hospital Inselspital, BerneUniversity of Bern;Roche Pharma AGNot recruiting50 YearsN/ABoth30Phase 2Switzerland
39NCT01400464July 200919 February 2015Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell ArteritisStudy the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell ArteritisGiant Cell ArteritisDrug: Prednisone therapy and pharmacokineticUniversity Hospital, CaenNot recruiting50 YearsN/ABoth150Phase 4France
40NCT00556439December 20084 January 2016Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's ArteritisConcurrent 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 VasculitisTakayasu's Arteritis;Giant Cell ArteritisDrug: Abatacept;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)The Cleveland Clinic;Office of Rare Diseases (ORD);Rare Diseases Clinical Research NetworkNot recruiting15 YearsN/ABoth98Phase 2United States;Canada
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
41NCT00305539May 200619 February 2015HECTHOR: Humira to Spare Steroids in Giant Cell ArteritisHECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell ArteritisGiant Cell ArteritisDrug: adalimumab;Drug: placeboAssistance Publique - Hôpitaux de ParisAbbottNot recruiting50 YearsN/ABoth69Phase 3France
42NCT00076726November 200319 February 2015A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell ArteritisA Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell ArteritisGiant Cell ArteritisDrug: InfliximabCentocor, Inc.The Cleveland ClinicNot recruiting50 YearsN/ABoth44Phase 2United States;Belgium;Italy;Spain;United Kingdom
43NCT00430807January 200219 October 2015Hydroxychloroquine in Giant Cell ArteritisMulticentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.Giant Cell ArteritisDrug: hydroxychloroquine/placeboUniversity Hospital, ToulouseNot recruiting18 Years85 YearsBoth75Phase 3France
44NCT00138983May 200019 February 2015Prevention 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 GranulomatosisDrug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)UMC UtrechtDutch Health Care Insurance BoardNot recruiting18 Years90 YearsBoth200Phase 3Netherlands
45NCT00006055March 200019 February 2015Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, 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 ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNot recruiting1 Year55 YearsBoth10N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00004686February 19947 April 2015Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell ArteritisGiant Cell ArteritisDrug: methotrexate;Drug: prednisoneThe Cleveland ClinicNot recruiting50 YearsN/ABoth300Phase 2

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