Clinical trial NCT02584517: Aetiology of TemporaL Arteritis Study
Official title: Understanding the Aetiology and Pathogenesis of Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Temporal Arteritis
Keywords: Vasculitis
Autoimmune disease
Connective tissue disease
Polymyalgia rheumatica
Musculoskeletal Diseases
Immune disorder
Rheumatic disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University of Leeds
First posted: 2015-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed study will recruit a cohort of eligible patients (predominantly from primary care referrals) suspected by their referring doctor to have new onset of GCA.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Phenotyping of innate lymphoid cells (ILC) in the arterial wall and blood of patients with GCA
timeFrame: 24 months
Secondary outcomes:
measure: CD70 in GCA
timeFrame: 12 months
measure: IL-7 and sIL-7R in GCA
timeFrame: 36 months
measure: Vascular Endothelial Growth Factor (VEGF) levels over time
timeFrame: 36 months
measure: Pentraxin 3 levels over time
timeFrame: 36 months
measure: Archiving of tissue for future studies
timeFrame: 60 months+
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Raashid A Luqmani, DM FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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