Duration of Immune Response to Influenza Vaccination in Patients With RA
Completed · Phase 4
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT02311855
- Run by
- Bassett Healthcare
- People needed
- 87
- Starts
- 2014-08-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-01-06
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Bassett Healthcare Network — Cooperstown, New York, United States
Full record on ClinicalTrials.gov
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