NCT02897011

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

September 7, 2016

Last Update Submit

October 26, 2016

Conditions

Rheumatoid ArthritisInfluenzaMethotrexate

Outcome Measures

Primary Outcomes (1)

  • Proportion of satisfactory vaccine response

    Proportion of satisfactory vaccine response that is defined as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains

    4 weeks

Secondary Outcomes (5)

  • Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains

    4 weeks

  • Proportion of seroprotection for each strain

    4 weeks

  • Change from baseline in titer (in GMT) for each strain

    4 weeks

  • Change from baseline in DAS28-4 (CRP) at 4 weeks after vaccination

    4 weeks

  • Proportion of patients who experience increase in disease activity

    4 weeks

Study Arms (2)

Group 1: MTX continue

SHAM COMPARATOR

Group will continue MTX after vaccination

Drug: Methotrexate

Group 2: MTX hold

EXPERIMENTAL

will hold MTX for 2 weeks after vaccination

Drug: Methotrexate

Interventions

MethotrexateDRUG
Group 1: MTX continueGroup 2: MTX hold

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National Univ. Bundang Hospital

Bundang, Gyeonggi-do, 463-870, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, Seoul, 156-707, South Korea

RECRUITING

Related Publications (2)

  • Park JK, Choi Y, Winthrop KL, Song YW, Lee EB. Optimal time between the last methotrexate administration and seasonal influenza vaccination in rheumatoid arthritis: post hoc analysis of a randomised clinical trial. Ann Rheum Dis. 2019 Sep;78(9):1283-1284. doi: 10.1136/annrheumdis-2019-215187. Epub 2019 Mar 23. No abstract available.

    PMID: 30904830DERIVED

  • 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.

    PMID: 29572291DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidInfluenza, Human

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

KR(3)