41. 巨細胞性動脈炎
[臨床試験数:108,薬物数:111(DrugBank:32),標的遺伝子数:33,標的パスウェイ数:121

Searched query = "Giant cell arteritis", "Temporal arteritis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04633447
(ClinicalTrials.gov)
December 1, 20206/11/2020A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell ArteritisA 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 ArteritisGiant Cell ArteritisDrug: Guselkumab;Drug: PlaceboJanssen Research & Development, LLCNULLNot yet recruiting50 YearsN/AAll60Phase 2United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain
2NCT04012905
(ClinicalTrials.gov)
November 5, 20205/7/2019Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids TaperingA Randomized, Controled, Open Label Trial: Comparison Between Two Standardized 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 yet recruiting50 YearsN/AAll150Phase 3NULL
3NCT04474847
(ClinicalTrials.gov)
November 202013/7/2020Abatacept for the Treatment of Giant Cell ArteritisA Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)Giant Cell ArteritisDrug: Abatacept;Drug: PlaceboUniversity of PennsylvaniaNULLNot yet recruiting50 YearsN/AAll78Phase 3United States
4EUCTR2019-003964-30-GB
(EUCTR)
22/10/202031/07/2020Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS) Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS)
MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Infliximab
Product Code: N/A
INN or Proposed INN: Infliximab
Trade Name: Rituximab
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Tocilizumab
Product Name: Tocilizumab
Product Code: N/A
INN or Proposed INN: Tocilizumab
Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2United Kingdom
5NCT04239196
(ClinicalTrials.gov)
July 1, 202019/11/2019Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCAOpen 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 ArteritisGiant Cell Arteritis;Optic Ischaemic NeuropathyDrug: tocilizumab and IV steroids combination;Other: IV steroids combination aloneCentre Hospitalier National d'Ophtalmologie des Quinze-VingtsRoche ChugaiNot yet recruiting50 YearsN/AAll58Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03892785
(ClinicalTrials.gov)
January 27, 202026/3/2019MEthotrexate 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 DijonNULLRecruiting50 YearsN/AAll200Phase 3France
7EUCTR2017-002988-18-FI
(EUCTR)
02/10/201912/09/2019Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3Portugal;Serbia;United States;Estonia;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Slovenia;Finland;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Croatia;Germany;Norway;Sweden
8EUCTR2017-003978-13-DK
(EUCTR)
17/09/201925/02/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Denmark;Australia;Netherlands;Germany;Japan;New Zealand
9NCT03812302
(ClinicalTrials.gov)
September 9, 201918/1/2019Use 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 AlbertaNULLRecruiting50 YearsN/AAll15Phase 2Canada
10EUCTR2017-003978-13-FR
(EUCTR)
22/08/201919/04/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolone 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03923738
(ClinicalTrials.gov)
August 5, 201919/4/2019A 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 RocheNULLCompleted50 YearsN/AAll23Phase 1Switzerland
12EUCTR2017-003978-13-GR
(EUCTR)
26/07/201918/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: SELECT GCA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
13EUCTR2017-003978-13-PT
(EUCTR)
08/07/201914/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
14NCT03656627
(ClinicalTrials.gov)
June 27, 201931/8/2018Nivolumab 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
15EUCTR2017-003978-13-NL
(EUCTR)
26/06/201926/06/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-003978-13-ES
(EUCTR)
22/05/201927/05/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis 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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
17EUCTR2017-003978-13-BE
(EUCTR)
15/05/201901/05/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
18EUCTR2017-003978-13-AT
(EUCTR)
15/05/201905/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
19EUCTR2017-003978-13-DE
(EUCTR)
14/05/201905/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
20EUCTR2017-003978-13-HU
(EUCTR)
08/05/201925/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-002988-18-HR
(EUCTR)
15/04/201917/05/2019Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
22EUCTR2018-001003-36-HR
(EUCTR)
10/04/201917/05/2019A 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 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]
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
23EUCTR2017-002988-18-SI
(EUCTR)
22/03/201919/12/2018Evaluation 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 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]
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finished 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
24EUCTR2018-002826-22-FR
(EUCTR)
07/03/201921/11/2018MEthotrexate 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]
CHU Dijon BourgogneNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: no
200Phase 3France
25EUCTR2017-002988-18-GB
(EUCTR)
04/03/201920/06/2019Evaluation 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 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]
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
508Phase 3Portugal;United States;Estonia;Slovenia;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03841734
(ClinicalTrials.gov)
March 20195/2/2019Study 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 NiceNULLNot yet recruiting50 YearsN/AAll8Phase 3France
27EUCTR2018-001003-36-DE
(EUCTR)
27/02/201921/06/2018A 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 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.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
28EUCTR2017-002988-18-PT
(EUCTR)
25/02/201905/11/2018Evaluation 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 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]
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
508Phase 3Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
29EUCTR2017-002988-18-AT
(EUCTR)
19/02/201928/09/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
30EUCTR2018-004072-35-FR
(EUCTR)
13/02/201906/11/2018 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]
CHU de NiceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
8Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low 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 PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States
32NCT03765788
(ClinicalTrials.gov)
January 30, 20193/12/2018A 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 PharmaceuticalsNULLActive, not recruiting50 YearsN/AAll52Phase 2Germany
33NCT03725202
(ClinicalTrials.gov)
January 24, 201927/10/2018A 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 Arteritis: SELECT-GCAGiant Cell Arteritis (GCA)Drug: Upadacitinib;Drug: Corticosteroid (CS);Other: PlaceboAbbVieNULLRecruiting50 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
34NCT03711448
(ClinicalTrials.gov)
January 7, 201915/10/2018Ustekinumab 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 DijonNULLRecruiting50 YearsN/AAll38Phase 2France
35EUCTR2017-002988-18-DK
(EUCTR)
04/01/201929/09/2018Evaluation 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 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]
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finished 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03827018
(ClinicalTrials.gov)
December 21, 201825/1/2019KPL-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.NULLActive, not recruiting50 Years85 YearsAll70Phase 2United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom
37EUCTR2018-000344-25-FR
(EUCTR)
18/12/201810/08/2018Essai, 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]
CHU CAENNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3France
38EUCTR2017-002988-18-NL
(EUCTR)
10/12/201801/11/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
39EUCTR2017-002988-18-BE
(EUCTR)
07/12/201806/03/2019Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
40EUCTR2018-002610-12-DE
(EUCTR)
06/12/201823/08/2018Study 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) - TitAIN Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Novartis Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-001003-36-GB
(EUCTR)
06/12/201820/06/2018A 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 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
42NCT03745586
(ClinicalTrials.gov)
December 1, 20186/11/2018Giant 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, BerneNULLRecruiting50 YearsN/AAll18Phase 1;Phase 2Switzerland;Italy
43EUCTR2018-001003-36-IT
(EUCTR)
30/11/201811/10/2018A 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 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]
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
44EUCTR2018-001003-36-BE
(EUCTR)
28/11/201816/08/2018A 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 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]
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
45NCT03726749
(ClinicalTrials.gov)
November 28, 201830/10/2018Tocilizumab 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2017-002988-18-DE
(EUCTR)
26/11/201826/09/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
47NCT03600805
(ClinicalTrials.gov)
November 20, 201817/7/2018Evaluation 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 PharmaceuticalsSuspended50 YearsN/AAll360Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;Denmark;Estonia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom
48EUCTR2017-002988-18-HU
(EUCTR)
19/11/201804/10/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
49EUCTR2018-001003-36-NL
(EUCTR)
13/11/201829/06/2018A 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 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]
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Netherlands;Germany;New Zealand
50EUCTR2017-002988-18-ES
(EUCTR)
19/10/201825/10/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2017-002988-18-EE
(EUCTR)
18/10/201815/10/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
52EUCTR2017-002988-18-SE
(EUCTR)
18/10/201811/10/2018Evaluation 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 arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
53EUCTR2018-001003-36-SI
(EUCTR)
03/10/201830/08/2018A 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 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.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
54EUCTR2018-001003-36-ES
(EUCTR)
08/08/201828/06/2018A 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 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
55EUCTR2018-001003-36-EE
(EUCTR)
09/07/201811/06/2018A 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 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03313102
(ClinicalTrials.gov)
November 16, 201713/10/2017Study 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 DijonNULLRecruiting51 YearsN/AAll60N/AFrance
57NCT03202368
(ClinicalTrials.gov)
October 25, 201727/6/2017An 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 RocheNULLCompleted50 YearsN/AAll3Phase 3France
58NCT03192969
(ClinicalTrials.gov)
July 15, 201714/6/2017A 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 SquibbNULLWithdrawn50 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
59EUCTR2016-002716-41-FR
(EUCTR)
24/05/201704/04/2017A STUDY TO EVALUATE LONG TERM SAFETY OF TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCEAN EXTENSION STUDY TO EVALUATE LONG TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE, AND SUBSEQUENTLY HAVING FLARE OR PERSISTING DISEASE ACTIVITY Giant cell arteritis (GCA)
MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra 162 mg solution for injection in pre-filled syringe
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
ROCHE SASNULLNot RecruitingFemale: yes
Male: yes
10Phase 3France
60NCT02902731
(ClinicalTrials.gov)
May 11, 20175/7/2016Giant 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, FRANCERecruiting51 YearsN/AAll70Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02985424
(ClinicalTrials.gov)
May 20171/12/2016Polymyalgia Rheumatica and Giant Cell ArteritisPolymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study ProtocolPolymyalgia Rheumatica;Giant Cell ArteritisOther: 18F-FDG PET/CTSvendborg HospitalOdense University HospitalNot yet recruiting18 Years95 YearsAll80N/ADenmark
62NCT03026504
(ClinicalTrials.gov)
March 9, 201717/1/2017Baricitinib 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 CompanyActive, not recruiting50 YearsN/AAll15Phase 2United States
63NCT02955147
(ClinicalTrials.gov)
December 1, 201631/10/2016Ustekinumab 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 HospitalNULLTerminated50 YearsN/AAll13Phase 1;Phase 2United States
64EUCTR2015-005804-27-FR
(EUCTR)
04/06/201629/01/2016GiAnT (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: KINERETCHU CAENNULLNot RecruitingFemale: yes
Male: yes
70Phase 3France
65EUCTR2015-001758-14-HU
(EUCTR)
15/04/201619/01/2016A 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 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2015-001758-14-NL
(EUCTR)
04/02/201626/08/2015A 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]
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
67EUCTR2015-001758-14-BG
(EUCTR)
08/01/201621/10/2015A 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 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
68EUCTR2015-001758-14-DE
(EUCTR)
18/12/201515/07/2015A 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 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
69EUCTR2015-001758-14-BE
(EUCTR)
14/12/201505/02/2016A 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 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
70NCT02531633
(ClinicalTrials.gov)
October 16, 20156/7/2015Efficacy 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 prednisoneGlaxoSmithKlineNULLTerminated50 YearsN/AAll161Phase 3United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02857192
(ClinicalTrials.gov)
October 5, 201529/6/2016Study 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 DijonNULLCompleted51 YearsN/AAll41N/AFrance
72EUCTR2015-001758-14-ES
(EUCTR)
30/09/201531/07/2015A 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 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
73EUCTR2013-002778-38-EE
(EUCTR)
12/02/201513/01/2015A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway
74EUCTR2013-002778-38-FI
(EUCTR)
04/02/201514/10/2014A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Norway
75EUCTR2013-002778-38-BE
(EUCTR)
21/01/201509/12/2014A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2013-002778-38-IE
(EUCTR)
19/01/201509/01/2015A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway
77NCT03244709
(ClinicalTrials.gov)
January 1, 20151/8/2017Tocilizumab 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 PratoNULLRecruiting18 Years90 YearsAll15Phase 4Italy
78EUCTR2013-002778-38-DK
(EUCTR)
18/12/201409/12/2014A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Norway
79EUCTR2013-002778-38-AT
(EUCTR)
18/12/201410/12/2014A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway
80NCT03285945
(ClinicalTrials.gov)
October 201412/10/2016FDG 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: PET3;Drug: PET10University of AarhusNULLCompleted50 YearsN/AAll24N/ADenmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2013-002778-38-GB
(EUCTR)
29/07/201429/10/2013A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway
82EUCTR2013-002778-38-CZ
(EUCTR)
12/02/201406/01/2014A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway
83EUCTR2013-002778-38-ES
(EUCTR)
14/01/201418/10/2013A 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 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 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
84EUCTR2013-002778-38-IT
(EUCTR)
11/11/201302/10/2013A 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 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)NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Denmark
85NCT01910038
(ClinicalTrials.gov)
November 8, 201317/7/2013Evaluation 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 DijonNULLCompleted50 YearsN/AAll20Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2011-006022-25-NL
(EUCTR)
09/10/201324/05/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden
87EUCTR2011-006022-25-BE
(EUCTR)
30/09/201317/06/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
88EUCTR2011-006022-25-PL
(EUCTR)
09/09/201316/07/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
89NCT01791153
(ClinicalTrials.gov)
July 22, 201312/2/2013An 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 RocheNULLCompleted50 YearsN/AAll251Phase 3United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria
90EUCTR2011-006022-25-ES
(EUCTR)
24/06/201310/06/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2011-006022-25-DK
(EUCTR)
14/06/201314/05/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden;United States;Spain;Portugal
92EUCTR2011-006022-25-PT
(EUCTR)
07/06/201322/05/2013A 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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
93EUCTR2011-006022-25-DE
(EUCTR)
06/06/201313/05/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
94EUCTR2011-006022-25-GB
(EUCTR)
23/05/201315/05/2013A 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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
95EUCTR2011-006022-25-SE
(EUCTR)
16/05/201307/05/2013A 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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2011-006022-25-AT
(EUCTR)
14/05/201310/05/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
97EUCTR2011-006022-25-IT
(EUCTR)
05/05/201307/03/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;Italy;United Kingdom;France;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden
98JPRN-UMIN000008812
2012/10/0101/10/2012Efficacy 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 ImmunologySaitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old80years-oldMale and Female40Not selectedJapan
99EUCTR2011-005090-22-GB
(EUCTR)
28/02/201217/01/2012A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA Giant Cell Arteritis
MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: Lodotra
Product Name: Lodotra (delayed release prednisolone)
INN or Proposed INN: Prednisolone
Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
Southend HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
100NCT01450137
(ClinicalTrials.gov)
September 20113/10/2011Tocilizumab 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 AGCompleted50 YearsN/AAll30Phase 2Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT01400464
(ClinicalTrials.gov)
July 200921/7/2011Steroids 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, CaenNULLActive, not recruiting50 YearsN/ABoth150Phase 4France
102NCT00556439
(ClinicalTrials.gov)
December 20089/11/2007Abatacept 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 NetworkCompleted15 YearsN/AAll97Phase 2United States;Canada
103NCT00305539
(ClinicalTrials.gov)
May 200621/3/2006HECTHOR: 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 ParisAbbottCompleted50 YearsN/ABoth69Phase 3France
104NCT00076726
(ClinicalTrials.gov)
November 20032/2/2004A 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 ClinicTerminated50 YearsN/ABoth44Phase 2United States;Belgium;Italy;Spain;United Kingdom
105NCT00430807
(ClinicalTrials.gov)
January 200231/1/2007Hydroxychloroquine 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, ToulouseNULLCompleted18 Years85 YearsBoth75Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT00138983
(ClinicalTrials.gov)
May 200029/8/2005Prevention 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 BoardCompleted18 Years90 YearsBoth200Phase 3Netherlands
107NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous 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 CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States
108NCT00004686
(ClinicalTrials.gov)
February 199424/2/2000Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell ArteritisGiant Cell ArteritisDrug: methotrexate;Drug: prednisoneThe Cleveland ClinicNULLCompleted50 YearsN/ABoth300Phase 2NULL