Effect of COVID-19 vaccination in Rheumatoid arthritis patients
Not Applicable
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2021/09/036579
- Lead Sponsor
- AIIMS Bibnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age >18 years
Both sex
Willing to participate in the study
Diagnosed case of rheumatoid arthritis (clinically, radiologically, laboratically)
Both seropositive and seronegative RA
On treatment with DMARDS (single or combination)
Intend to receive vaccine against COVID-19
Post COVID-19 (3month after recovery)
Exclusion Criteria
Cancer and other autoimmune/ Immune suppressants disorders
Patients on immunosuppressive therapy other than DMARDs
Allergy and Contraindication to vaccination
Patients with active SARS CoV-2 infection
Patients on alternative systems of medicine for RA
Patients with known interstitial lung disease
Pregnant or breastfeeding woman
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Immunological response- Number of patients with neutralizing antibodies after 1 month, 3months and 6months post vaccination <br/ ><br>2.Number of patients with symptomatic infection by COVID-19 during follow-up period <br/ ><br>3.Number of patients with worsening /improvement of clinical symptoms of RA <br/ ><br>Timepoint: one three and six months <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Proportion of patients with persistent neutralizing antibodies â?? time frame 6month <br/ ><br>â?¢Number of RA patients developing adverse effects due to vaccination <br/ ><br>Mortality in COVD-19 infected RA patients after vaccination <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: ADRs every 15 days