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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTX discontinuation | Experimental | methotrexate stop for 2 weeks after each shingrix vaccination |
|
| MTX continuation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster) | baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| , Humoral immunity (anti-VZV antibody, anti-gE antibody) | baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Ki Min, MD, PhD | Contact | +82-10-9977-5455 | alsghdrl1921@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Ki Min, MD, PhD | Konkuk University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Recruiting | Seoul | South Korea |
IPD can be shared with reasonable request.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate | Drug | methotrexate continuation group : keep methotrexate |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |