Status:
COMPLETED
Duration of Immune Response to Influenza Vaccination in Patients With RA
Lead Sponsor:
Bassett Healthcare
Collaborating Sponsors:
New York State Department of Health
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 comp...
Detailed Description
Aims: * Evaluate the strength and duration of immune response after influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents. * Evaluate for predict...
Eligibility Criteria
Inclusion
- Inclusion criteria (RA Patients)
- Patients with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent
- Age 40-75
- Inclusion Criteria (Healthy Controls):
- Age 40-75
Exclusion
- Exclusion criteria (RA Patients)
- 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)
- Exclusion Criteria(Healthy Controls):
- 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
- Recent acute illness (within 1 month prior to vaccination)
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT02311855
Start Date
August 1 2014
End Date
February 1 2016
Last Update
January 6 2017
Active Locations (1)
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1
Bassett Healthcare Network
Cooperstown, New York, United States, 13326