MedPath

CD4+ T cells and immune ageing; major players and predictors for disease activity in giant cell arteritis

Recruiting
Conditions
Large vessel vasculitis and Polymyalgia rheumatica
10003816
10010761
Registration Number
NL-OMON44732
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1500
Inclusion Criteria

GCA patients
1. Fulfilling ACR criteria for GCA
2. Not yet treated with corticosteroids
3. Age >= 50 years
4. Being able to give informed consent

GCA patients in remission
1. Fulfilling ACR criteria for GCA
2. Age >= 50 years
3. Being able to give informed consent ;PMR patients
1. Fulfilling Healey criteria for PMR
2. Not yet treated with corticosteroids
3. Age >= 50 years
4. Being able to give informed consent

;PMR patients in remission
1. Fulfilling Healey criteria for PMR
2. Age >= 50 years
3. Being able to give informed consent ;Healthy controls
1. Having no chronic disease
2. Age >= 50 years
3. Being healthy according to SENIEUR protocol
4. Being able to give informed consent;Infectious controls
1. Having no chronic disease
2. Age >= 50 years
3. Being healthy according to SENIEUR protocol, exept for an urinary tract or upper airway infection
4. Being able to give informed consent

Exclusion Criteria

GCA patients
1. Not fulfilling the ACR criteria for GCA
2. Concomitant chronic diseases that may affect immune system (such as prior or current malignant disease, active infectious disease, other rheumatological disease, kidney disease, active allergy etc.) ;PMR patients
1. Not fulfilling Healey criteria for PMR
2. Concomitant chronic diseases that may affect immune system (such as prior or current malignant disease, active infectious disease, other rheumatological disease, kidney disease, active allergy etc.) ;Healthy controls
1. Having chronic diseases
2. Not being healthy according to SENIEUR protocol;Infectious controls
1. Having chronic diseases
2. Not being healthy according to SENIEUR protocol, except for an urinary or upper airway infection.;GCA patients, PMR patients, healthy and infectious controls
1. No informed consent
2. Severe anaemia defined as a Hb of less than 6,0 g/dL

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Is there a relation between CD4+ T cell subset diversity and GCA?</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Which cell subsets migrate into the arterial wall in GCA?<br /><br>- Are there any biomarkers (CD4+ T cell subsets, cytokines, IRP) predicting<br /><br>relaps in GCA patients?<br /><br>- Is there a relation between the IRP and frailty?<br /><br>- Are there any biomarkers (CD4+ T cell subsets, cytokines, IRP) that<br /><br>distinguish PMR patients from GCA patients, or from patients that have both<br /><br>diseases?<br /><br>- Which cell subsets migrate into the joints of PMR patients?<br /><br>- Are there shifts in the cell subsets in GCA and PMR patients in remission<br /><br>- Which genes are involved in the pathogenesis of GCA and PMR</p><br>
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