Effect of MTX Discontinuation on Shingrix Response in RA
ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKonkuk University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
age over 19 years
methotrexate user
agree for vaccination with shingrix
Disqualifiers
have other form of inflammatory arthritis or autoimmune-mediated disease
malignancy, current infection, pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Methotrexate
Drugmethotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
Methotrexate
Drugmethotrexate continuation group : keep methotrexate
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: MTX discontinuationExperimental treatment 1 intervention
Group B: MTX continuationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)
Time frame
baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccinationSecondary outcomes
1
, Humoral immunity (anti-VZV antibody, anti-gE antibody)
Time frame
baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccinationSponsors and contacts
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Source ClinicalTrials.gov