2-week dc of MTX and Influenza Vaccination in RA (2 wk MTX)
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ClinicalTrials.gov Identifier: NCT02897011 |
Recruitment Status : Unknown
Verified October 2016 by Eun Bong Lee, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : September 12, 2016
Last Update Posted : October 27, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis Influenza Methotrexate | Drug: Methotrexate | Not Applicable |
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects the joints as the main target of the inflammation. Patients with RA require chronic treatment with disease modifying antirheumatic drugs (DMARDs) including methotrexate (MTX), which constitutes the mainstay of treatment. Underlying immune dysfunction and the additional immune suppression associated with treatment render patients with RA more susceptible to infection. Thus, vaccination of the preventive diseases is crucial and recommended in all patients unless contraindicated.
However, low dose of glucocorticoids, conventional DMARDs and biological DMARDs including tumor necrosis factor inhibitors have been reported to substantially decrease vaccine response (4); MTX has been reported to be associated with a decreased response to seasonal influenza vaccination by up to 15%.
To optimize a vaccine response, vaccination should be administrated before the treatment with immunesuppressive medications is initiated. However, most patients with RA are already on stable dose of MTX at the time of when vaccinations. To improve the vaccine response, a short term discontinuation of MTX could be considered. In a prior study, we discovered that a temporary discontinuation of MTX for 4 weeks during peri-vaccination period tended to be associated with an improved response to vaccination with trivalent influenza vaccination (Figure 1). It remains to be defined whether MTX discontinuation for shorter period increases the vaccination efficacy while minimizing the RA flare rate.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 318 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial |
Study Start Date : | September 2016 |
Estimated Primary Completion Date : | August 2017 |
Estimated Study Completion Date : | August 2017 |

Arm | Intervention/treatment |
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Sham Comparator: Group 1: MTX continue
Group will continue MTX after vaccination
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Drug: Methotrexate |
Experimental: Group 2: MTX hold
will hold MTX for 2 weeks after vaccination
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Drug: Methotrexate |
- Proportion of satisfactory vaccine response [ Time Frame: 4 weeks ]Proportion of satisfactory vaccine response that is defined as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains
- Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains [ Time Frame: 4 weeks ]
- Proportion of seroprotection for each strain [ Time Frame: 4 weeks ]
- Change from baseline in titer (in GMT) for each strain [ Time Frame: 4 weeks ]
- Change from baseline in DAS28-4 (CRP) at 4 weeks after vaccination [ Time Frame: 4 weeks ]
- Proportion of patients who experience increase in disease activity [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females ≥ 19 years and < 65 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
- 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
- Any condition including laboratory abnormality which places the subject at unacceptable risk
- Subjects who decline to participate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897011
Korea, Republic of | |
Seoul National Univ. Bundang Hospital | Recruiting |
Bundang, Gyeonggi-do, Korea, Republic of, 463-870 | |
Contact: Yun Jong Lee, MD PhD +82-31-787-4051 leeyn35@gmail.com | |
Principal Investigator: Yun Jong Lee, MD PhD | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Eun Bong Lee, MD PhD 82-2-2072-3944 leb7616@snu.ac.kr | |
Contact: Hyun Mi Kwon, MD 82-2-2072-3198 hmikwon@gmail.com | |
Principal Investigator: Eun Bong Lee, MD PhD | |
SMG-SNU Boramae Medical Center | Recruiting |
Seoul, Korea, Republic of, 156-707 | |
Contact: Kichul Shin, MD PhD +82-2-870-3204 kideb1@snu.ac.kr | |
Principal Investigator: Kichul Shin, MD PhD |
Responsible Party: | Eun Bong Lee, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT02897011 |
Other Study ID Numbers: |
SNUH-IMJ-003 |
First Posted: | September 12, 2016 Key Record Dates |
Last Update Posted: | October 27, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Influenza, Human Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents |