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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTX 1 week hold | Experimental | Patients who will hold MTX for 1 week after an influenza vaccine. |
|
| MTX 2 week hold | Active Comparator | Patients who will hold MTX for 2 weeks after an influenza vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTX-hold | Drug | Temporary discontinuation of methotrexate for 1 or 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of seroprotection for each strain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea | ||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31823141 | Result | 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. | |
| 29572291 | Result | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Single-blinded study. Investigators assessing disease activity will be blinded to the treatment arm.
| 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 |
| Seoul |
| 03080 |
| South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| 28468794 | Result | 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. |
| 35930728 | Derived | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |