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Effect of COVID-19 vaccination in Rheumatoid arthritis patients

Clinical and immunological responses to COVID-19 vaccination in Rheumatoid arthritis patients on treatment with DMARDsâ?? A Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036579
Enrollment
96
Registered
2021-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

AIIMS Bibnagar
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1.Immunological response- Number of patients with neutralizing antibodies after 1 month, 3months and 6months post vaccination 2.Number of patients with symptomatic infection by COVID-19 during follow-up period 3.Number of patients with worsening /improvement of clinical symptoms of RA Timepoint: one three and six months

Secondary

MeasureTime frame
â?¢ Proportion of patients with persistent neutralizing antibodies â?? time frame 6month â?¢ Number of RA patients developing adverse effects due to vaccination Mortality in COVD-19 infected RA patients after vaccination Timepoint: ADRs every 15 days

Countries

India

Contacts

Public ContactMadhavi Eerike

AIIMS Bibinagar

dr.madhavieerike@gmail.com08685279338

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026