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Post Covid-19 Vaccination Development or Flare of ARD

New or Flare of Musculoskeletal Rheumatic Diseases After Different COVID-19 Vaccines: Multicentre Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05160428
Acronym
PoCov-ARD
Enrollment
500
Registered
2021-12-16
Start date
2022-02-01
Completion date
2023-10-31
Last updated
2023-01-11

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

Conditions

COVID-19, Rheumatic Diseases, Vaccination; Infection

Brief summary

Many patients develop autoimmune diseases after covid-19 vaccination, whether related to the vaccination or not, is still under study. This study will describe potential flare of ARD after COVID-19 vaccination, whether it leads to activity or new MSK manifestations development.

Detailed description

-In this study: patients with known diagnosed rheumatic diseases who are vaccinated (one or full doses) of any type of COVID-19 vaccines will be enrolled. new ARD and prevalence of different MSK manifestations after covid-19 vaccinations also will be reported. The prevalence of flare of ARD after covid-19 vaccinations will be dteremined. Also we will compare between different types and doses of covid-19 vaccinations in inducing ARD or flares. Study Design: Cross sectional study Target population: any patient with pre-existing received any vaccination against covid-19 visiting rheumatology outpatient clinic. -any patient develops MSK manifestations after covid-19 vaccination. The disease activity sataus will be measured according to the type of rheumatic disease. For RA , disease activity score28 will be used, in lupus: SLEDAI, in Behcet : BDCAF, in SpA: BASDAI.

Interventions

BIOLOGICALCOVID-19 vaccination

different types of covid-19 vaccinations.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Age above 18 years Vaccinated against covid-19 (one dose or fully vaccinated)

Exclusion criteria

Receiving other vaccine e.g influenza Less than 18 years old

Design outcomes

Primary

MeasureTime frameDescription
-Prevalence of new ARD after covid-19 vaccinations3 mothsany ARD
prevalence of flare of ARD after covid-19 vaccinations3 monthsflare of any manifestations of the disease

Secondary

MeasureTime frameDescription
comparison between different type of covid-19 vaccine in inducing ARD or flare up.3 monthsany type of flare
Prevalence of non-specific MSK symptoms after Covid-19 vaccine.3 monthsany MSK symptoms
Any correlation between the appearance of MSK symptoms and the patient's medications3 monthscurrent medications
disease activity status in the patients who developed the ARD symptoms before and after the vaccine.3 monthsactivity assessed by disease activity scores
Correlation of the MSK to the 1st and 2nd Covid vaccine dose3 monthsCorrelation of the MSK to the 1st and 2nd Covid vaccine dose

Countries

Egypt

Contacts

Primary ContactMervat Eissa, MD
metvateissa@kasralainy.edu.eg+201221738939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026