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To understand the immunogenicity of Covisheild vaccine in patients with RA by discontinuing methotrexate temporarily

Effect Of Temporary Methotrexate Discontinuation On Immunogenicity Of COVISHIELD Vaccination In Patients With Autoimmune Rheumatic disease(AIRD) : A Randomized controlled trial - MTX Vaccine study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034639
Enrollment
230
Registered
2021-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: M061- Adult-onset Stills disease Health Condition 2: M315- Giant cell arteritis with polymyalgia rheumatica Health Condition 3: M058- Other rheumatoid arthritis with rheumatoid factor Health Condition 4: M060- Rheumatoid arthritis without rheumatoid factor Health Condition 5: M45-M49- Spondylopathies Health Condition 6: M30-M36- Systemic connective tissue disorders

Interventions

Intervention1: Methotrexate: The patients with AIRD randomized to two groups - one group continues methotrexate Route oral and Sub cutaneous , Dose and duration - same dose as the patient is tak

Sponsors

Centre for Arthritis and Rheumatism Excellence CARE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria Patient above 18 years of age. Patients willing to give consent for the study Patients with a prior diagnosis of Autoimmune Rheumatic disease(AIRD) stable dose for at least the past 2 months

Exclusion criteria

Exclusion criteria: Exclusion Criteria Patients who had covid-19 infection in the past. Patients with history of allergy to vaccine components . Prior GBS/demyelinating syndromes Any live vaccine taken within prior 4 weeks or inactivated vaccine in last 2 weeks before study

Design outcomes

Primary

MeasureTime frame
the anti spike/neutralizing antibody titre and T cell ELIspot assay will be assessed 1 month after the second dose of vaccine and to see if there is statistically significant difference among the two groups studiedTimepoint: 1 month post 2nd dose vaccine

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr S Anu

Dr Shenoy�s Care Private Limited

drdpshenoy@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 13, 2026