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NCT06574594 | RECRUITING | Rheumatoid Arthritis


Effect of MTX Discontinuation on Shingrix Response in RA
Sponsor:

Konkuk University Medical Center

Information provided by (Responsible Party):

Hong Ki Min

Brief 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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

Methotrexate

Methotrexate

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
Actual Study Start Date : 2024-08-22
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Effect of MTX Discontinuation on Shingrix Response in RA

Location Details

NCT06574594


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Locations


RECRUITING

Korea, Republic of,

Konkuk University Medical Center

Seoul, Korea, Republic of,

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