Trials / Recruiting
RecruitingNCT06574594
Effect of MTX Discontinuation on Shingrix Response in RA
Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Konkuk University Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are: Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ? Researchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups. Participants will: Vaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination. Visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \& 6 months later from baseline to achieve blood sample.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methotrexate | methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination |
| DRUG | Methotrexate | methotrexate continuation group : keep methotrexate |
Timeline
- Start date
- 2024-08-22
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2024-08-28
- Last updated
- 2024-08-28
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06574594. Inclusion in this directory is not an endorsement.