41. 巨細胞性動脈炎 Giant cell arteritis Clinical trials / Disease details


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125

  
57 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05380453
(ClinicalTrials.gov)
September 21, 202222/2/2022Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical RemissionA Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapyGiant Cell ArteritisBiological: Secukinumab 300 mg, s.c.;Drug: Placebo to match Secukinumab, s.c.Novartis PharmaceuticalsNULLRecruiting50 YearsN/AAll146Phase 3Germany
2EUCTR2021-002528-18-DK
(EUCTR)
22/02/202230/07/2021RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency.RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency; A multicentre, randomised, double blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis receiving ongoing low-dose prednisolone treatment. - RESCUE Glucocorticoid-induced adrenal insufficiency
MedDRA version: 20.0;Level: LLT;Classification code 10001369;Term: Adrenal insufficiency NOS;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Hydrokortison orion
Product Name: hydrokortison
Product Code: H02AB09
INN or Proposed INN: hydrocortisone
Other descriptive name: HYDROCORTISONE
Copenhagen University Hospital RigshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 4Denmark
3NCT04474847
(ClinicalTrials.gov)
March 15, 202113/7/2020Abatacept 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 PennsylvaniaNULLActive, not recruiting50 YearsN/AAll78Phase 3United States;Canada
4EUCTR2020-000622-26-DE
(EUCTR)
22/01/202117/09/2020A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects 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 Arteritis - THEIA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Spain;Poland;Belgium;Israel;Germany;Italy
5EUCTR2020-000622-26-IT
(EUCTR)
18/12/202024/05/2021A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects 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 Arteritis - THEIA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Product Name: Guselkumab
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg
Product Name: Guselkumab
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2France;United States;Canada;Spain;Poland;Belgium;Germany;Italy
6NCT04633447
(ClinicalTrials.gov)
December 10, 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, LLCNULLRecruiting50 YearsN/AAll51Phase 2United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain
7NCT04239196
(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
8NCT05394909
(ClinicalTrials.gov)
February 7, 202020/5/2022Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA PatientsTreatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational StudyGCA;TOCILIZUMAB;Glucocorticoids;PETDrug: Tocilizumab 162Mg/0.9Ml AutoinjectorAzienda Unità Sanitaria Locale Reggio EmiliaNULLActive, not recruitingN/AN/AAll20Italy
9NCT03892785
(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/AAll230Phase 3France
10EUCTR2018-001003-36-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]
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
11EUCTR2018-002826-22-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]
Trade Name: METOJECT
Trade Name: RoActemra
CHU Dijon BourgogneNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: no
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
12NCT03841734
(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
13EUCTR2018-001003-36-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
14EUCTR2018-004072-35-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]
Trade Name: BOSENTAN MYLAN
Product Name: BOSENTAN MYLAN
CHU de NiceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
15NCT03711448
(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
16EUCTR2018-001003-36-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
17NCT03745586
(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, BerneNULLCompleted50 YearsN/AAll18Phase 1/Phase 2Switzerland;Italy
18EUCTR2018-001003-36-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]
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 finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
19EUCTR2018-001003-36-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]
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 finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
20EUCTR2018-001003-36-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: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Netherlands;Germany;New Zealand
21EUCTR2018-001003-36-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
22EUCTR2018-001003-36-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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
23EUCTR2018-001003-36-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
24NCT03192969
(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
25NCT02955147
(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
26EUCTR2015-001758-14-IT
(EUCTR)
08/06/201620/01/2021A study to assess the efficacy and safety of Sirukumab in the treatment ofpatients with Giant Cell Arteritis, using multiple sites, and an untreatedpatient 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 - NA Giant Cell Arteritis (GCA)
MedDRA version: 20.0;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Trade Name: Capsule di prednisone
INN or Proposed INN: PREDNISONE
Trade Name: Prednisone Capsule
INN or Proposed INN: PREDNISONE
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone capsule
INN or Proposed INN: PREDNISONE
Other descriptive name: Prednisone
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
204Phase 3New Zealand;Sweden;United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands
27EUCTR2015-001758-14-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
28EUCTR2015-001758-14-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]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
204 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
29EUCTR2015-001758-14-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
30EUCTR2015-001758-14-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
31EUCTR2015-001758-14-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
32NCT02531633
(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
33EUCTR2015-001758-14-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
34EUCTR2013-002778-38-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
35EUCTR2013-002778-38-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
36EUCTR2013-002778-38-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
37EUCTR2013-002778-38-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
38EUCTR2013-002778-38-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
39EUCTR2013-002778-38-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
40NCT03285945
(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
41EUCTR2013-002778-38-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
42EUCTR2013-002778-38-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
43EUCTR2013-002778-38-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
44EUCTR2013-002778-38-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
45EUCTR2011-006022-25-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
46EUCTR2011-006022-25-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
47EUCTR2011-006022-25-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
48EUCTR2011-006022-25-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
49EUCTR2011-006022-25-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
50EUCTR2011-006022-25-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]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
51EUCTR2011-006022-25-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
52EUCTR2011-006022-25-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]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
53EUCTR2011-006022-25-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]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
54EUCTR2011-006022-25-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
55JPRN-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)Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old80years-oldMale and Female40Not selectedJapan
56NCT00305539
(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
57NCT00004686
(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