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Shingles Vaccines for Rheumatoid Arthritis (BMS-188667 Trial)
BMS-188667 Trial Summary
This trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies.
BMS-188667 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBMS-188667 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BMS-188667 Trial Design
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Who is running the clinical trial?
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- I am currently undergoing radiation or chemotherapy for cancer.My dose of DMARDs has not been stable for more than 30 days.I am currently using TNF blockers.I am currently being treated with abatacept.I am currently being treated with abatacept.I am living with HIV/AIDS.I have not used any corticosteroids in the last 28 days.I have not received any inactivated vaccines within 14 days of the study injections.I am 50 years old or older.I am 18 years old or older.I am a woman who has been post-menopausal for over a year or have had both ovaries or my uterus removed.My condition affects my bone marrow or lymphatic system.I am a woman who has been post-menopausal for over a year or have had both ovaries or my uterus removed.I have had chickenpox or a positive chickenpox antibody test.I haven't received, nor plan to receive, any live vaccines around the time of the study vaccinations.I have leukemia.I haven't had any inactivated vaccines in the last 7 days.I have taken anti-viral medications for herpesvirus in the last 30 days.I am a woman who can have children, used birth control for 30 days, tested negative for pregnancy, and will continue birth control for 2 months after my last vaccine.I have received Zostavax® over 6 months ago if enrolling in the Shingrix® study.I am allergic to gelatin or another vaccine ingredient.I have not received a live virus vaccine in the last 28 days.I am a woman who can have children and am considering joining the Shingrix sub-study.I take more than 25 mg of methotrexate weekly.I do not have any current infections or sudden illnesses.I am 50 years old or older.I am 18 years old or older.
- Group 1: Placebo Injection (Shingrix Comparator)
- Group 2: Varicella Zoster Vaccine (Shingrix)
- Group 3: Varicella Zoster Vaccine (Zostavax)
- Group 4: Placebo Injection (Zostavax Comparator)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the recruitment for this trial still open?
"Affirmative. According to the clinicaltrials.gov database, this research study is actively searching for new participants after it was published on May 8th 2014 and its most recent update occured on September 7th 2022. The goal of the trial is to recruit 130 individuals from 4 different medical sites."
Are there any sites in North America that are presently administering this experiment?
"Presently, 4 locations are facilitating the trial: Hixson, Portland and Boise (as well as 4 additional sites). To reduce commuting demands, it is advised that potential participants select a clinic near to their residence."
What potential risks come with taking the Varicella Zoster Vaccine?
"While Phase 2 trials provide some indication of safety, but lack efficacy data, our team at Power have assessed Varicella Zoster Vaccine's safety to be a score of 2."
How many participants are there in this research trial?
"To run the trial, a total of 130 qualified patients must be enrolled. Bristol-Myers Squibb are managing this endeavour from multiple sites including Arthritis Associates in Hixson Tennessee and Oregon Health & Science University based in Portland, Oregon."
What other research has been done concerning the Varicella Zoster Vaccine?
"The Varicella Zoster Vaccine was first trialled in 2007 at the Children's Hospital of Geneva (HUG). To date, 162 such studies have been completed and there are presently 26 active investigations. A substantial proportion of these experiments are conducted out of Hixson, Tennessee."
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