Rheumatoid ArthritisNCT06574594
Effect of MTX Discontinuation on Shingrix Response in RA
A study testing Methotrexate in people with Rheumatoid Arthritis, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Methotrexate
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
- age over 19 years
- methotrexate user
- agree for vaccination with shingrix
Who cannot join
- have other form of inflammatory arthritis or autoimmune-mediated disease
- malignancy, current infection, pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul
Hong Ki Min, MD, PhD, +82-10-9977-5455, alsghdrl1921@naver.com
About this study
Official title: Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
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 ?
Read more
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
- Rheumatoid Arthritis
- Being tested
- Methotrexate
- Keywords
- herpes zoster, Shingrix, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
MethotrexateDrug
methotrexate continuation group : keep methotrexate
| Study group | Role | What they receive |
|---|---|---|
| MTX discontinuation | Experimental | methotrexate stop for 2 weeks after each shingrix vaccination Receives: Drug: Methotrexate |
| MTX continuation | Active comparator | Not described Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)
Measured: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
Secondary outcomes (1)
, Humoral immunity (anti-VZV antibody, anti-gE antibody)
Measured: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start22 Aug 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Ki Min, Konkuk University Medical Center
- Investigators
- Hong Ki Min, MD, PhD, Study chair, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574594
- Sponsor's protocol ID
- 2024-02-038
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared with reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06574594
- Acronym / sponsor ID
- 2024-02-038
- Conditions
- Rheumatoid Arthritis
- Keywords
- herpes zoster, Shingrix, methotrexate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 22 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX discontinuation | Experimental | Drug: Methotrexatemethotrexate stop for 2 weeks after each shingrix vaccination |
| MTX continuation | Active comparator | Drug: Methotrexate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
- age over 19 years
- methotrexate user
- agree for vaccination with shingrix
Key exclusion criteria (2 listed)
- have other form of inflammatory arthritis or autoimmune-mediated disease
- malignancy, current infection, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexatemethotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination | Drug | MTX discontinuation |
| Methotrexatemethotrexate continuation group : keep methotrexate | Drug | MTX continuation |
Primary outcome
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 vaccination
1 secondary outcome
, 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 vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No. IPD can be shared with reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Ki Min, MD, PhD study chair
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate in people with Rheumatoid Arthritis, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Ki Min, MD, PhD (+82-10-9977-5455, alsghdrl1921@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.