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To understand the immunogenicity of Covisheild vaccine in patients with rheumatological disease by discontinuing methotrexate temporarily after taking second dose of vaccine

Effect Of Discontinuation of Methotrexate, post 2nd dose on Immunogenicity Of ChAdOx1 nCoV -19 Corona Virus (COVISHIELD)Vaccination in Patients With Autoimmune Rheumatic diseases who continued their Methotrexate doses after 1st dose : A Single Centre Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035307
Enrollment
230
Registered
2021-07-30
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: M45- Ankylosing spondylitis Health Condition 3: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 4: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 5: M315- Giant cell arteritis with polymyalgia rheumatica Health Condition 6: M06- Other rheumatoid arthritis Health Condition 7: M058- Other rheumatoid arthritis with rheumatoid factor Health Condition 8: M

Interventions

Intervention1: Methotrexate - as oral or IV form 2.5 to 30 mg: The patients with AIRD randomized to other group which discontinue Methotrexate temporarily for 2 weeks post 2nd dose of Covisheild vacc

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 and on methotrexate , stable dose for atleast the past 2 months

Exclusion criteria

Exclusion criteria: Patients who had covid-19 infection in the past. Patients who are not willing for blood sample collection. Patients with h/o 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
To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose. To see the effect of short term discontinuation of Methotrexate on AIRD disease activity.Timepoint: To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose.—

Secondary

MeasureTime frame
nilTimepoint: nil—

Countries

India

Contacts

Public ContactDr RASHWITH U

Dr Shenoys Care Private Limited

drdpshenoy@gmail.com9446567000

Outcome results

None listed

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