Efficacy of vaccine responses against SARS-Cov-2 in patients with giant cell arteritis and polymyalgia rheumatica (GPSVAC)
Phase 4
Recruiting
- Conditions
- Giant cell arteritis / Temporal arteritis100038161004743810010761
- Registration Number
- NL-OMON51139
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Give written informed consent
Diagnosed with GCA or PMR
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
Concomitant chronic diseases that may affect the immune system (such as prior
or current malignant disease, active infectious disease, other rheumatic
disease, kidney disease, active allergy etc.)
Severe anaemia defined as a hemoglobin of less than 6,0 g/dL
Confirmed SARS-CoV-2 infection (current or previous)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessment of humoral (antibody) immune responses to the coronavirus vaccine<br /><br>in GCA/PMR patients compared to the reference values and to matched healthy<br /><br>controls. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Assessment of cellular (T-cell) immune responses to the coronavirus vaccine in<br /><br>GCA/PMR patients<br /><br>Documentation of vaccination side-effects</p><br>