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"
39 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03892785January 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
2EUCTR2017-002988-18-FI02/10/201912/09/2019Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
3EUCTR2017-002988-18-HR15/04/201917/05/2019Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
4EUCTR2018-001003-36-DE27/02/201921/06/2018A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
5EUCTR2017-002988-18-AT19/02/201928/09/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03711448January 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
7EUCTR2017-002988-18-NL10/12/201801/11/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
8EUCTR2017-002988-18-BE07/12/201806/03/2019Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
9EUCTR2018-001003-36-GB06/12/201820/06/2018A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
10NCT03726749November 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
11EUCTR2017-002988-18-DE26/11/201826/09/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
12NCT03600805November 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
13EUCTR2017-002988-18-HU19/11/201804/10/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
14EUCTR2017-002988-18-ES19/10/201825/10/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
15EUCTR2017-002988-18-EE18/10/201815/10/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-002988-18-SE18/10/201811/10/2018Evaluation 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
17EUCTR2018-001003-36-SI03/10/201830/08/2018A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
18EUCTR2018-001003-36-ES08/08/201828/06/2018A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
19EUCTR2018-001003-36-EE09/07/201811/06/2018A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
20NCT02955147December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-001758-14-HU15/04/201619/01/2016A 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: 20.0Level: HLGTClassification code 10047116Term: Vascular inflammationsSystem 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
22EUCTR2015-001758-14-BG08/01/201621/10/2015A 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: 19.0Level: HLGTClassification code 10047116Term: Vascular inflammationsSystem 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
23EUCTR2015-001758-14-DE18/12/201515/07/2015A 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: 19.1Level: HLGTClassification code 10047116Term: Vascular inflammationsSystem 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
24EUCTR2015-001758-14-BE14/12/201505/02/2016A 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
25NCT02531633October 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
26EUCTR2015-001758-14-ES30/09/201531/07/2015A 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
27EUCTR2011-006022-25-NL09/10/201324/05/2013A 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: 17.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
28EUCTR2011-006022-25-BE30/09/201317/06/2013A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
29EUCTR2011-006022-25-PL09/09/201316/07/2013A 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: 19.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
30NCT01791153July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-006022-25-ES24/06/201310/06/2013A 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: 16.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
32EUCTR2011-006022-25-DK14/06/201314/05/2013A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
33EUCTR2011-006022-25-DE06/06/201313/05/2013A 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: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
34EUCTR2011-006022-25-AT14/05/201310/05/2013A 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: 17.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
35EUCTR2011-006022-25-IT05/05/201307/03/2013A 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: 14.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-005090-22-GB28/02/201217/01/2012A 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: 14.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem 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
37NCT01400464July 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
38NCT00006055March 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
39NCT00004686February 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