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| Name | Class |
|---|---|
| New York State Department of Health | OTHER_GOV |
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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.
Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccination | Other | all patients are vaccinated per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of influenza infection | proportion of patients who are diagnosed with confirmed influenza despite vaccination | 6 months post vaccination |
| Occurrence of flu-like illnesses | proportion of patient who developed influenza-like symptoms (defined as two or more of the following: cough, myalgias, fever, arthralgias, throat pain, headache, nasal congestion). |
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Inclusion Criteria:
Inclusion criteria (RA Patients)
Inclusion Criteria (Healthy Controls):
Exclusion Criteria:
Exclusion criteria (RA Patients)
Exclusion Criteria(Healthy Controls):
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| Name | Affiliation | Role |
|---|---|---|
| Donald Raddatz, MD | Bassett Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bassett Healthcare Network | Cooperstown | New York | 13326 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 10, 2019 | |
| Reset | Jul 31, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 10, 2019 | Jul 31, 2019 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C000618615 | Fluzone High-Dose |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 6 months post vaccination |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |