Rheumatoid Arthritis Clinical Trial
Official title:
Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents
Verified date | January 2017 |
Source | Bassett Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | February 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
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) |
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Bassett Healthcare Network | Cooperstown | New York |
Lead Sponsor | Collaborator |
---|---|
Bassett Healthcare | New York State Department of Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Occurrence of influenza infection | proportion of patients who are diagnosed with confirmed influenza despite vaccination | 6 months post vaccination | No |
Secondary | 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). | 6 months post vaccination | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |