Rheumatoid Arthritis Clinical Trial
Official title:
Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)
NCT number | NCT02538341 |
Other study ID # | VERVE-UM1 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | December 2020 |
Verified date | October 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the Herpes zoster (HZ) vaccine for shingles, Zostavax, in patients over 50 years old with arthritis and other diseases who are using anti-tumor necrosis factor (TNF) therapy and who have not previously received the vaccine.
Status | Completed |
Enrollment | 617 |
Est. completion date | December 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Must be 50 years of age or older - Must be currently treated with an anti-tumor necrosis factor (TNF) therapy** at the time of study drug administration, allowing for small deviations in dosing frequency and logistic feasibility (e.g. study visits to occur on a week day). Date of previous dose of medication is required. Specifically, meets one of the following: Etanercept dose within 9 days (1 week + 2 days), Adalimumab dose within 16 days (2 weeks + 2 days), Certolizumab Subcutaneous (SC) dose within 16 to 32 days depending on frequency schedule (2 weeks + 2 days, or 4 weeks and 4 days), Golimumab Subcutaneous (SC) dose within 32 days (4 weeks + 4 days), Golimumab Intravenous (IV) dose within 64 days (9 weeks + 1 day), Infliximab IV dose within last 64 days (9 weeks + 1 day) **any form of biosimilar for the above listed anti-tumor necrosis factor (TNF) medications is acceptable - Diagnosis of rheumatoid arthritis or another inflammatory arthritis (Phase 1A); or other inflammatory condition (e.g. psoriasis) requiring use of anti-tumor necrosis factor (TNF) therapy (Phase 1B and II) - Phase I subjects must test positive for varicella-zoster virus (VZV) antibody immunoglobulin G (IgG) - Subjects should have a self-reported history of prior varicella infection (i.e. chicken pox) or long-term residence (>30 years) in the continental United States. - Phase IA subjects must not have received any oral or systemic glucocorticoids within 30 days prior to vaccination. Intra-articular glucocorticoid injections and inhaled glucocorticoids within the previous 30 days are acceptable. - Subjects should be on stable doses of all biologic and non-biologic Disease-modifying antirheumatic drugs (DMARDs) for a minimum of 30 days prior to vaccination. - Eligible women must be post-menopausal (> 1 year since last menstrual period) or have a surgical history of bilateral oophorectomy or hysterectomy. - Subjects should be ambulatory, community dwelling and capable of giving informed consent. Exclusion Criteria: - Documented varicella-zoster virus (VZV) antibody immunoglobulin G (IgG) negative result - Prior use of the zoster vaccine (Zostavax®, Merck) - Glucocorticoids at a prednisone-equivalent daily dose > 10mg/day (for Phase 1B and Phase II participants; all systemic glucocorticoid use is prohibited for Phase 1A patients) - Any known contraindication to Zostavax® vaccine, including allergy or sensitivity to gelatin or any other vaccine component - Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) - Currently receiving radiation or chemotherapy for any type of malignancy - Any current use (within the last 30 days) of acyclovir, valacyclovir, famciclovir, or foscarnet - Receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., diphtheria-tetanus (dT), pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 6 weeks after recruitment. - Active infection or inter-current illness (e.g., urinary tract infection, influenza) - Participated in an investigational study within 1 month prior to study entry - Active drug or alcohol use, dependence, or any other reason that, in the opinion of the site investigator, would interfere with the study - Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years) - Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g. uncontrolled comorbidity, life expectancy < 1 year) - Patients who have household contact with varicella-susceptible pregnant women or severely immunosuppressed individuals without history of primary varicella. |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Rheumatology, LLP | Albany | New York |
United States | Ochsner Clinic Baton Rouge | Baton Rouge | Louisiana |
United States | Rheumatology Associates, PC | Birmingham | Alabama |
United States | Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Boston Medical Center | Boston | Massachusetts |
United States | The Ohio State University | Columbus | Ohio |
United States | Mary Imogene Bassett Hospital, Bassett Research Institute | Cooperstown | New York |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | St. Paul Rheumatology | Eagan | Minnesota |
United States | Pine Hollow Partners | East Lansing | Michigan |
United States | Arthritis Associates, PLLC | Hixson | Tennessee |
United States | Rheumatology Associates of North Alabama, PC | Huntsville | Alabama |
United States | West Tennessee Research Institute | Jackson | Tennessee |
United States | North Georgia Rheumatology Group | Lawrenceville | Georgia |
United States | Rheumatology Consultants of Delaware dba Delaware Arthritis | Lewes | Delaware |
United States | Arthritis Association of Southern California | Los Angeles | California |
United States | The Regents of the University of California Los Angeles | Los Angeles | California |
United States | Southwest Rheumatology Research, LLC | Mesquite | Texas |
United States | Center for Arthritis and Rheumatic Diseases | Miami | Florida |
United States | Coral Research Clinic Corp | Miami | Florida |
United States | Carolina Health Specialists | Myrtle Beach | South Carolina |
United States | Ochsner Clinic Foundation, New Orleans | New Orleans | Louisiana |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Arthritis Research of Florida, Inc | Palm Harbor | Florida |
United States | SunValley Arthritis Center, Ltd | Peoria | Arizona |
United States | Oregon Health & Science University | Portland | Oregon |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Sarasota Arthritis Research Center | Sarasota | Florida |
United States | Rheumatology & Osteoporosis Specialists | Shreveport | Louisiana |
United States | West Virginia Research Institute, PLLC | South Charleston | West Virginia |
United States | West Broward Rheumatology Associates, Inc | Tamarac | Florida |
United States | Clinical and Translational Research Center of Alabama, PC | Tuscaloosa | Alabama |
United States | Arthritis Research Center Foundation, NDB | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 6 Weeks | Study protocol defined measure for immunogenicity samples. | 6 weeks post vaccination | |
Primary | GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 6 Weeks | Study protocol defined measure for immunogenicity samples. | 6 weeks post vaccination | |
Secondary | GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 1 Year | Study defined measure from labs. GMFR (Geometric Mean Fold Rise ) in varicella zoster virus (VZV) glycoprotein enzyme-linked immunosorbent assay (gpELISA) immunoglobulin G (IgG) levels | Baseline to 1 year | |
Secondary | GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 1 Year | Study defined measures from labs. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) enzyme-linked immune absorbent spot (ELISpot) interferon gamma (IFNg) | Baseline to 1 year | |
Secondary | Number of Samples With Confirmed Varicella | Evaluated all serious adverse events (SAEs) AND non-serious varicella zoster virus (VZV) events | "Placebo Normal Saline Arm/Group was assessed up to 6 months and the "Zoster Vaccine Live (Zostavax)" Arm/Group was assessed up to 1 year | |
Secondary | Vaccine Tolerability Within 42 Days Following Vaccination. | Patient self report data in the form of a diary to include injection site reactions; symptoms of swelling, redness or tenderness. Diary was completed from study injection administration up to 6 week visit | 42 days post vaccination | |
Secondary | Evaluate Rheumatoid Arthritis Disease Activity Using the Clinical Disease Activity Index (CDAI) | Rheumatoid arthritis disease activity will be measured using the clinical disease activity index (CDAI). Clinical disease activity index (CDAI) is a measure of rheumatoid arthritis disease activity and is scored on a scale ranging from 0-76, with lower numbers indicated better control of disease. Values <=10 are consistent with low disease activity or remission. | 42 days post vaccination |
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