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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069714
• Other study ID #: 2109-020-1252
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Influenza
• Influenza, Human
• Rheumatoid Arthritis
• Vaccine Reaction

Intervention

Drug:
• MTX-hold
Temporary discontinuation of methotrexate for 1 or 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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/s10067-019-0 — View 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 — View 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 tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of satisfactory vaccine response	as = 4-fold increase in post-vaccination titer in = 2 of 4 influenza strains at 4 weeks after vaccination	4 weeks
Secondary	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	4 weeks and 16 weeks
Secondary	Proportion of seroprotection for each strain		4 weeks and 16 weeks
Secondary	Change from baseline in titer (in GMT)		4 weeks and 16 weeks
Secondary	Change from baseline in DAS28-4 (CRP)		4 weeks and 16 weeks
Secondary	Disease flare		4 weeks and 16 weeks