An observational study to investigate the effectiveness and safety of Corona vaccines in patients with rheumatologic diseases.
- Conditions
- Auto Immune Rheumatic Diseases (AIRD) and patients without rheumatic autoimmune diseases (control group).MedDRA version: 20.0Level: PTClassification code 10072736Term: Rheumatic disorderSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-002245-15-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 250
1. written consent for study participation.
2. if study entry after first vaccination: written informed consent for analysis of any archived blood samples.
3. males and females = 18 years of age.
4. either arm 1 (AIRD patients): diagnosis of rheumatic autoimmune disease or arm 2 (control group): no diagnosis of rheumatic autoimmune disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. persons not capable of giving consent
2. serious illnesses which, in the opinion of the investigator, preclude inclusion or continued observation (for example, tumor diseases requiring intensive chemotherapy).
3. individuals who are unable or unwilling to undergo multiple venipunctures because he/she is intolerant or has poor venous conditions.
4. persons who are admitted to an institution by court order or by order of the authorities.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method