drugset / Trial / NCT05069714
One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2022-09-30
- Completion
- 2022-09-30
Outcome
Met primary endpoint
paper CONCLUSION: A temporary discontinuation of MTX for 1 week after vaccination was noninferior to a discontinuation of MTX for 2 weeks after vaccination PMID 35930728 ↗
Publications
- Results 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 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 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.
- Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | — | — |