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2-week dc of MTX and Influenza Vaccination in RA (2 wk MTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

Brief Summary:
To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves the vaccination response to a seasonal influenza.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Influenza Methotrexate Drug: Methotrexate Not Applicable

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Sham Comparator: Group 1: MTX continue
Group will continue MTX after vaccination
Drug: Methotrexate
Experimental: Group 2: MTX hold
will hold MTX for 2 weeks after vaccination
Drug: Methotrexate

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains [ Time Frame: 4 weeks ]
  2. Proportion of seroprotection for each strain [ Time Frame: 4 weeks ]
  3. Change from baseline in titer (in GMT) for each strain [ Time Frame: 4 weeks ]
  4. Change from baseline in DAS28-4 (CRP) at 4 weeks after vaccination [ Time Frame: 4 weeks ]
  5. Proportion of patients who experience increase in disease activity [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02897011

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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   
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   
Contact: Hyun Mi Kwon, MD    82-2-2072-3198   
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   
Principal Investigator: Kichul Shin, MD PhD         
Sponsors and Collaborators
Seoul National University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eun Bong Lee, Professor, Seoul National University Hospital 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
Additional relevant MeSH terms:
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Influenza, Human
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents