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Giant Cell Arteritis clinical trials

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NCT ID: NCT04142515 Completed - Clinical trials for Giant Cell Arteritis

Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated for Giant Cells ARTEitis (Horton's Disease)

CARTECEL
Start date: February 1, 2020
Phase:
Study type: Observational

Giant cell arteritis (GCA) or Horton's disease: frequent large vessel vasculitis (cephalic) (incidence estimated at 9 per 100,000 in France), potentially responsible for blindness. Treatment: corticosteroid therapy, which is effective in the vast majority of cases. Clinical problem: relapse; 36% to 44% of patients have a relapse that occurs in the first year for many patients, requiring a re-escalation of corticosteroid therapy, with its consequences: - Cumulative dose of corticosteroid therapy that causes cardiovascular and infectious morbidity. - Requires additional immunosuppressive treatment.

NCT ID: NCT04027101 Completed - Clinical trials for Polymyalgia Rheumatic (PMR)

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

BACHELOR
Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included. Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment. No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion. From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.

NCT ID: NCT03941184 Completed - Clinical trials for Rheumatoid Arthritis

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Start date: January 1, 1995
Phase:
Study type: Observational

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.

NCT ID: NCT03923738 Completed - Clinical trials for Giant Cell Arteritis

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

Start date: August 5, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).

NCT ID: NCT03827018 Completed - Clinical trials for Giant Cell Arteritis

KPL-301 for Subjects With Giant Cell Arteritis

Start date: September 20, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

NCT ID: NCT03812302 Completed - Clinical trials for Giant Cell Arteritis

Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)

Start date: September 9, 2019
Phase: Phase 2
Study type: Interventional

The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.

NCT ID: NCT03765788 Completed - Clinical trials for Giant Cell Arteritis

A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis

TitAIN
Start date: January 30, 2019
Phase: Phase 2
Study type: Interventional

This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell arteritis (GCA) who were naïve to biological therapy.

NCT ID: NCT03765424 Completed - Clinical trials for Giant Cell Arteritis

Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis

Start date: October 1, 2014
Phase:
Study type: Observational

The aim of this project is to prospectively evaluate the diagnostic accuracy of different imaging tools in specific giant cell arteritis disease subsets before and after treatment initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for optimal treatment of GCA patients. Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore, long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to explore the potential of imaging as monitoring and prognostic tools. In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients as compared to a control group of patients with a previous diagnosis of malignant melanoma was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945 and NCT03409913, respectively)

NCT ID: NCT03745586 Completed - Clinical trials for Giant Cell Arteritis

Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab

GUSTO
Start date: December 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Two recent RCTs showed the ability of tocilizumab to induce and maintain remission of giant cell arteritis. Both studies used the dosing schemes for Rheumatoid Arthritis (i.e. 8mg/kg bodyweight i.v. in 4-weekly intervals and 162mg weekly s.c., respectively). In both trials glucocorticoids (GC) were initially administrated at medium to high doses with subsequent rapid reduction and discontinuation over 24 weeks. In case of relapse, GC doses were re-increased. The results of both studies suggest that GC could be reduced more rapidly. This would further reduce GC-induced adverse effects. Thus, the investigators propose to perform an open label single arm study to assess the efficacy of ultra-short co-medication with GC, using Simon's minimax two-stage design.

NCT ID: NCT03726749 Completed - Clinical trials for Giant Cell Arteritis

Tocilizumab Plus a Short Prednisone Taper for GCA

Start date: November 28, 2018
Phase: Phase 4
Study type: Interventional

This is an open-label pilot study of tocilizumab (TCZ) 162 mg weekly administered subcutaneously for 52 weeks in combination with 8 weeks of oral prednisone.