Phase 4
Completed N=277
MTX Discontinuation and Vaccine Response
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02748785 ↗
Enrolled (actual)
277
Serious AEs
1.0%
Results posted
Oct 2018
Primary outcomePrimary: Satisfactory Vaccination Responses Against 3 Antigens — 31.5; 22.7; 51; 46.2 percentage of responders
◆ Published Evidence
Highly cited
138citations · ~15 / year
Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial.
Summary
To investigate whether a short term discontinuation of methotrexate (MTX) will improve the vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease activity in a randomized clinical trial.
Linked Publications
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Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfactory Vaccination Responses Against 3 Antigens |
31.5; 22.7; 51; 46.2 | — |
| PRIMARY Satisfactory Vaccination Responses Against > 2/3 Antigens |
53.7; 52.3; 71.4; 65.4 | — |
| PRIMARY Satisfactory Vaccination Responses Against > 1/3 Antigens |
77.8; 81.8; 87.8; 88.5 | — |
| SECONDARY Proportion of Seroprotection Against H1N1 |
74; 86; 96; 86 | — |
| SECONDARY Proportion of Seroprotection Against H3N2 |
100; 96; 98; 96 | — |
| SECONDARY Proportion of Seroprotection Against B-Yamagata |
72; 71; 94; 81 | — |
| SECONDARY Change From Baseline in Antibody Titer Against H1N1 |
5.1; 5.0; 8.7; 8.1 | — |
| SECONDARY Change From Baseline in Antibody Titer Against H3N2 |
5.9; 6.1; 12.2; 10.0 | — |
| SECONDARY Change From Baseline in Antibody Titer Against B-Yamagata |
2.9; 2.8; 4.7; 6.1 | — |
| SECONDARY DAS28 Flare Rate at Visit 4 |
7.5; 14.0; 19.1; 12.0 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females > 18 years 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
- Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study
- Blood transfusion within 6 months
- Active rheumatoid arthritis necessitating a recent change in the drug regimen
- Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
Data sourced from ClinicalTrials.gov (NCT02748785) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.