Impact of stopping methotrexate on Shingrix vaccine response in rheumatoid arthritis patients
Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
This study is testing if stopping methotrexate for two weeks helps people with rheumatoid arthritis get a better immune response to the Shingrix vaccine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Konkuk University Medical Center Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06574594 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether discontinuing methotrexate affects the immune response to the Shingrix vaccine in patients with rheumatoid arthritis (RA). Participants will receive the Shingrix vaccine twice, with one group continuing methotrexate treatment and the other group stopping it for two weeks after vaccination. The study will compare the immune responses, both humoral and cell-mediated, between the two groups to determine the efficacy of the vaccine. Blood samples will be collected at various intervals to assess the immune response over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 19 years old who have been diagnosed with rheumatoid arthritis and are currently using methotrexate.
Not a fit: Patients with other forms of inflammatory arthritis, autoimmune diseases, malignancies, current infections, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of the Shingrix vaccine in RA patients, potentially reducing their risk of herpes zoster.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have explored the effects of immunosuppressive medications on vaccine responses, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis * age over 19 years * methotrexate user * agree for vaccination with shingrix Exclusion Criteria: * have other form of inflammatory arthritis or autoimmune-mediated disease * malignancy, current infection, pregnancy
Where this trial is running
Seoul
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hong Ki Min, MD, PhD
- Email: alsghdrl1921@naver.com
- Phone: +82-10-9977-5455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.