Expired Study
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Cooperstown, New York 13326


Purpose:

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.


Study summary:

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 predictors of immune response such as age, gender, disease duration, type of the biological agent(s) used, duration of the treatment, and type of treatment in the past. - Assess the efficacy of vaccine response in this population by recording proportion of patients who contracted influenza illness despite vaccination. The result of the study may provide more information regarding which situations inadequate immune response by strength or duration would most likely to be expected. This may help lay some groundwork for future studies looking at the use of booster vaccinations in this population


Criteria:

Inclusion Criteria: 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 Criteria: 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)


NCT ID:

NCT02311855


Primary Contact:

Principal Investigator
Donald Raddatz, MD
Bassett Healthcare


Backup Contact:

N/A


Location Contact:

Cooperstown, New York 13326
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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