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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05069714

Collaborator

(none)

280

Enrollment

Locations

Arms

Anticipated Duration (Months)

93.3

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Autoimmune Diseases Influenza Vaccine Reaction	Drug: MTX-hold	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

Single-blinded study. Investigators assessing disease activity will be blinded to the treatment arm.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MTX 1 week hold Patients who will hold MTX for 1 week after an influenza vaccine.	Drug: MTX-hold Temporary discontinuation of methotrexate for 1 or 2 weeks
Active Comparator: MTX 2 week hold Patients who will hold MTX for 2 weeks after an influenza vaccine.	Drug: MTX-hold Temporary discontinuation of methotrexate for 1 or 2 weeks

Arm

Intervention/Treatment

Experimental: MTX 1 week hold

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

Drug: MTX-hold

Temporary discontinuation of methotrexate for 1 or 2 weeks

Active Comparator: MTX 2 week hold

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

Drug: MTX-hold

Temporary discontinuation of methotrexate for 1 or 2 weeks

Outcome Measures

Primary Outcome Measures

Proportion of satisfactory vaccine response [4 weeks]
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 [4 weeks and 16 weeks]
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 [4 weeks and 16 weeks]
Change from baseline in titer (in GMT) [4 weeks and 16 weeks]
Change from baseline in DAS28-4 (CRP) [4 weeks and 16 weeks]
Disease flare [4 weeks and 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
2	Seoul National University Hospital	Seoul		Korea, Republic of	03080
3	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of	156-707