NCT02311855

Brief Summary

The main objective is to evaluate the strength and duration of immune response after influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents as compared to a group healthy controls who do not have RA. Influenza vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the baseline visit after the baseline blood draw.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

December 4, 2014

Last Update Submit

January 5, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Initial Immune response

    proportion of subjects with at least a 4-fold increase in titer at 4-6 weeks postvaccination to this year's influenza vaccine antigens;

    4-6 weeks post vaccination

  • Total proportion of seroconversion

    proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period

    6 months post vaccination

Secondary Outcomes (2)

  • Occurrence of influenza infection

    6 months post vaccination

  • Occurrence of flu-like illnesses

    6 months post vaccination

Study Arms (1)

Influenza vaccination

OTHER

all patients are vaccinated per protocol

Biological: Influenza vaccine

Interventions

Influenza vaccineBIOLOGICAL

Each participant will have a blood draw to measure the antibody titres influenza strains covered by the 2014-2015 influenza vaccine at three different time points: Visit 1- Baseline/prior to vaccination Visit 2- 4-6 weeks post-vaccination Visit 3- end of influenza season (April-May) At Visit 1, after the baseline blood draw, all participants will be vaccinated by Research staff in order to standardize the time from Baseline blood draw to vaccination. Participants aged 65 and older will be offered the extra strength version of the vaccine, which is usual care. Participants under the age of 65 will be given the usual strength vaccine. All patients will be given the intramuscular (IM) vaccine.

Also known as: Fluzone, Fluzone High Dose
Influenza vaccination

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent
  • Age 40-75
  • Age 40-75

You may not qualify if:

  • Known hypersensitivity/allergy influenza vaccine
  • Chronic debilitating conditions (such as end-stage Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), liver disease, Chronic Kidney Disease (CKD) )
  • Active malignancy at time of vaccination
  • Pregnancy and lactation
  • Known HIV
  • Active infection at time of vaccination
  • Recent acute illness (within 1 month prior to vaccination)
  • Known autoimmune conditions
  • Chronic use of immunosuppressant treatments
  • Known hypersensitivity/allergy influenza vaccine
  • Chronic debilitating conditions (such as end-stage COPD, CHF, liver disease, CKD)
  • Active malignancy at time of vaccination
  • Pregnancy and lactation
  • Known HIV
  • Active infection at time of vaccination
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Influenza VaccinesFluzone High-Dose

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Donald Raddatz, MD

    Bassett Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Department of Medicine - Rheumatology

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)