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One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.

Primary Purpose

Rheumatoid Arthritis, Autoimmune Diseases, Influenza

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MTX-hold
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, methotrexate, influenza

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males or females ≥ 19 years of age at time of consent
  • Have a diagnosis of RA per ACR criteria
  • Must understand and voluntarily sign an informed consent form including writing consent for data protection
  • Stable doses of methotrexate over the preceding 6 weeks

Exclusion Criteria:

  • Pregnant or lactating females
  • Previous anaphylactic response to vaccine components or to egg.
  • Acute infection with T >38°C at the time of vaccination
  • History of Guillain-Barre syndrome or demyelinating syndromes
  • Blood transfusion within 6 months
  • Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
  • Any condition including laboratory abnormality which places the subject at unacceptable risk
  • Subjects who decline to participate

Sites / Locations

  • Seoul National Univ. Bundang Hospital
  • Seoul National University Hospital
  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MTX 1 week hold

MTX 2 week hold

Arm Description

Patients who will hold MTX for 1 week after an influenza vaccine.

Patients who will hold MTX for 2 weeks after an influenza vaccine.

Outcomes

Primary Outcome Measures

Proportion of satisfactory vaccine response
as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains at 4 weeks after vaccination

Secondary Outcome Measures

Proportio0n of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains
Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains at 4 weeks and 16 weeks after vaccination
Proportion of seroprotection for each strain
Change from baseline in titer (in GMT)
Change from baseline in DAS28-4 (CRP)
Disease flare

Full Information

First Posted
September 26, 2021
Last Updated
December 14, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05069714
Brief Title
One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.
Official Title
Effect of One-week vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (MTX) discontinuation for 1 week is non-inferior to MTX discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Autoimmune Diseases, Influenza, Vaccine Reaction
Keywords
rheumatoid arthritis, methotrexate, influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Single-blinded study. Investigators assessing disease activity will be blinded to the treatment arm.
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTX 1 week hold
Arm Type
Experimental
Arm Description
Patients who will hold MTX for 1 week after an influenza vaccine.
Arm Title
MTX 2 week hold
Arm Type
Active Comparator
Arm Description
Patients who will hold MTX for 2 weeks after an influenza vaccine.
Intervention Type
Drug
Intervention Name(s)
MTX-hold
Intervention Description
Temporary discontinuation of methotrexate for 1 or 2 weeks
Primary Outcome Measure Information:
Title
Proportion of satisfactory vaccine response
Description
as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains at 4 weeks after vaccination
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportio0n of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains
Description
Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains at 4 weeks and 16 weeks after vaccination
Time Frame
4 weeks and 16 weeks
Title
Proportion of seroprotection for each strain
Time Frame
4 weeks and 16 weeks
Title
Change from baseline in titer (in GMT)
Time Frame
4 weeks and 16 weeks
Title
Change from baseline in DAS28-4 (CRP)
Time Frame
4 weeks and 16 weeks
Title
Disease flare
Time Frame
4 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males or females ≥ 19 years of age at time of consent Have a diagnosis of RA per ACR criteria Must understand and voluntarily sign an informed consent form including writing consent for data protection Stable doses of methotrexate over the preceding 6 weeks Exclusion Criteria: Pregnant or lactating females Previous anaphylactic response to vaccine components or to egg. Acute infection with T >38°C at the time of vaccination History of Guillain-Barre syndrome or demyelinating syndromes Blood transfusion within 6 months Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease Any condition including laboratory abnormality which places the subject at unacceptable risk Subjects who decline to participate
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31823141
Citation
Park JK, Kim MJ, Choi Y, Winthrop K, Song YW, Lee EB. Effect of short-term methotrexate discontinuation on rheumatoid arthritis disease activity: post-hoc analysis of two randomized trials. Clin Rheumatol. 2020 Feb;39(2):375-379. doi: 10.1007/s10067-019-04857-y. Epub 2019 Dec 10.
Results Reference
result
PubMed Identifier
29572291
Citation
Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
Results Reference
result
PubMed Identifier
28468794
Citation
Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
Results Reference
result

Learn more about this trial

One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.

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