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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis; Autoimmune Diseases; Influenza; Vaccine Reaction
• Interventions: Drug: MTX-hold

• Registration Number: NCT05069714
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-26
• Study First Submitted QC: 2021-09-26
• Study Start: 2021-10-01
• Study First Posted: 2021-10-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTX 1 week hold	MTX-hold	Patients who will hold MTX for 1 week after an influenza vaccine.
MTX 2 week hold	MTX-hold	Patients who will hold MTX for 2 weeks after an influenza vaccine.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Disease flare	4 weeks and 16 weeks
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

Trial Locations

Locations (3)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of