DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione; 18F-FDG; ABT-494; AIN457; ANAKINRA; Abatacept; Adalimumab; Alendronate; Alendronate versus alfacalcidol (1-alpha OH vitamin D); Alfacalcidol; Anakinra; Anti-thymocyte globulin; BOSENTAN MYLAN; Baricitinib; Blood samples; Bosentan; CNTO 136; CORTANCYL; Combination Product: mavrilimumab; Cortancyl; Cortancyl ® 1 mg; Cortancyl ® 20 mg; Cortancyl ® 5 mg; Corticoids+ tocilizumab 8mg/Kg/4 weeks; Corticosteroid (CS); Corticosteroids; Corticosteroids for Systemic Use; Cosentyx; Cyclophosphamide; Cyclosporine; Diagnostic Test: 68-Ga HA-DOTATATE PET/CT; Dotatate; Encorton; Filgrastim; GSK2973327; Gevokizumab; Glucocorticoid Treatment; Glucocorticoids; Guselkumab; Hydroxychloroquine; Infliximab; KINERET; KPL-301; Kevzara; Kevzara ®; Kineret; Lodotra; Lodotra (delayed release prednisolone); MAVRILIMUMAB; METOJECT; Mavrilimumab; Methotrexate; Methotrexate treatment; Methylprednisolone; Naltrexone; Naltrexone Hydrochloride; Nivolumab; Other: 18F-FDG PET/CT; Other: IV steroids combination alone; Other: Questionnaires; Other: questionnaires; Over encapsulated prednisone; PET10; PET3; PREDNISOLONE; PREDNISONE; Pr; PredniSONE Tablets USP, 1 mg; PredniSONE Tablets USP, 2.5 mg; PredniSONE Tablets USP, 5 mg; PredniSONE Tablets, USP; Prednisolon 1 mg JENAPHARM; Prednisolon 5 mg JENAPHARM; Prednisolone; Prednisolone 5 mg JENAPHARM; Prednisone; Prednisone Capsules; Prednisone Tablets, USP; Prednisone and ustekinumab treatment; Prednisone therapy and pharmacokinetic; Prednisone treatment; Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Rituximab; Ro 001-9265; Ro 001-9265/F02; Ro 001-9265/F03; Ro 001-9265/F04; Ro 487-7533/F10-04; RoActemra; RoActemra 162 mg solution for injection in pre-filled syringe; S78989; SAR153191; SARILUMAB; SECUKINUMAB; Sarilumab; Sarilumab SAR153191; Secukinumab; Secukinumab 300 mg, s.c.; Sirukumab; TOCILIZUMAB; TOCILIZUMAB SC; Tocilizumab; Tocilizumab + Glucocorticoids (GCs); Tocilizumab SC; Tocilizumab and IV steroids combination; Tocilizumab treatment; Treatment; Upadacitinib; Ustekinumab; Vitamin D; XOMA 052

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom
2	NCT00076726 (ClinicalTrials.gov)	November 2003	2/2/2004	A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis	A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis	Giant Cell Arteritis	Drug: Infliximab	Centocor, Inc.	The Cleveland Clinic	Terminated	50 Years	N/A	Both	44	Phase 2	United States;Belgium;Italy;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003964-30-GB
(EUCTR)

22/10/2020

31/07/2020

Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.

Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)

Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS)
MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Infliximab
Product Code: N/A
INN or Proposed INN: Infliximab
Trade Name: Rituximab
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Tocilizumab
Product Name: Tocilizumab
Product Code: N/A
INN or Proposed INN: Tocilizumab

Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 2

United Kingdom

NCT00076726
(ClinicalTrials.gov)

November 2003

2/2/2004

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis

A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis

Giant Cell Arteritis

Drug: Infliximab

Centocor, Inc.

The Cleveland Clinic

Terminated

50 Years

N/A

Both

Phase 2

United States;Belgium;Italy;Spain;United Kingdom