Aetiology of TemporaL Arteritis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Giant Cell Arteritis (GCA) is the most common vasculitis and has significant morbidity in terms of blindness, stroke, and tissue necrosis. It requires protracted treatment with high-dose steroids, and despite this there is a risk of flare during the treatment. Little is known about the initial triggers for the inflammatory process, and there are no good markers of response or relapse. We will study patients referred with suspected GCA to identify important components of the immune response in GCA, and follow them over time to collect evidence of how best to monitor their condition.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers in Giant Cells Arteritis

NCT02844023

Giant Cells Arteritis

TERMINATED NA

Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

NCT00315497

Temporal Arteritis

COMPLETED

Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis

NCT06894602

Giant Cell Arteritis

NOT_YET_RECRUITING

Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy

NCT04554290

Giant Cell Arteritis Vasculitis

COMPLETED

Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL)

NCT00974883

Giant Cell Arteritis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objectives and Study Plan:

Study Purpose:

The purpose of the study is to investigate the underlying immunological processes in GCA and to study the pattern of expression of immune response over time to give us information about how best to monitor GCA.

End Point:

The end point will be the final visit of the final patient.

Milestones:

The project is in 3 phases. In phase 1 (0-2 years) patients will be recruited to fulfil the specified primary and secondary objectives. In phase 2 (0-4 years), these patients will be followed up for a total of 2 years each, or until they are discharged from clinic. In phase 3 (1-5 years), further studies will be defined and tissue and data collected under amended ethics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporal Arteritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GCA

Patients referred with suspected GCA, whose final diagnosis is GCA

No interventions assigned to this group

Not GCA

Patients referred with suspected GCA, whose final diagnosis is another disorder

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 years of age or over
2. A clinical suspicion of a new diagnosis of GCA e.g. patients with a new onset of headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue claudication with or without visual loss
3. Participants must be willing to give informed written consent or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities e.g. sudden onset of blindness/vision loss which can be caused by GCA (this will be made clear in the ethics approval application)

Exclusion Criteria

1. Previous diagnosis of GCA
2. Long term (\>1 month) high dose (\>20mg per day at any time) steroids for conditions other than PMR, within three months prior to study entry
3. Inability to give informed consent (either written consent or verbal assent from a relative or carer)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No