Aetiology of TemporaL Arteritis Study

Brief Title

Aetiology of TemporaL Arteritis Study

Official Title

Understanding the Aetiology and Pathogenesis of Giant Cell Arteritis

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.
    


Study Type

Observational


Primary Outcome

Phenotyping of innate lymphoid cells (ILC) in the arterial wall and blood of patients with GCA

Secondary Outcome

 CD70 in GCA

Condition

Temporal Arteritis


Study Arms / Comparison Groups

 GCA
Description:  Patients referred with suspected GCA, whose final diagnosis is GCA

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

200

Start Date

January 2016

Completion Date

January 2021

Primary Completion Date

January 2018

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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Raashid A Luqmani, DM FRCP, 01865227971, [email protected]



Administrative Informations


NCT ID

NCT02584517

Organization ID

ATLAS001


Responsible Party

Sponsor

Study Sponsor

University of Oxford

Collaborators

 University of Leeds

Study Sponsor

Raashid A Luqmani, DM FRCP, Principal Investigator, University of Oxford


Verification Date

October 2015