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COVID-19 Vaccines for Rheumatic Diseases
Study Summary
This trial will help to better understand the immunogenicity and safety of the Pfizer-BioNTech and Moderna COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I see a rheumatologist but don't need strong medication for my condition.I have not had COVID-19 in the last 14 days.I am scheduled for a COVID-19 booster shot.I am 18 years old or older.I am currently undergoing radiation or chemotherapy for cancer.I have received an adenoviral COVID-19 vaccine.I meet the guidelines for receiving HAVRIX® and BOOSTRIX® vaccines.I have been vaccinated for diphtheria, pertussis, or tetanus in the last 9 years.I have HIV/AIDS.I have had whooping cough, diphtheria, tetanus, or hepatitis A.I do not have any illnesses that would limit my life to less than a year.I haven't had vaccines other than for COVID-19 close to my COVID-19 vaccination dates.I have inflammatory arthritis and am on a stable dose of my medication.
- Group 1: Arm 2 (co-administration group)
- Group 2: Arm 4 (Inflammatory arthritis patients using DMARDS)
- Group 3: Arm 3 (co-administration group)
- Group 4: Arm 1 (control group, sequential administration)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many people have been recruited for this research project?
"Yes, this is an ongoing trial that will enroll 400 patients from 1 medical facility. The clinical study was first advertised on October 5th, 2020 and the most recent update to the information was made September 28th, 2020."
What are the risks associated with taking Arm 3 medication?
"Because this is a phase 4 clinical trial, meaning the intervention has already been approved, our team rates Arm 3 (co-administration group) as having a safety score of 3."
Are there any subjects needed for this research project?
"Yes, the information available on clinicaltrials.gov points to this trial currently being open for enrollment. 400 patients are needed from a single site, with the first posting dating back to October 5th, 2020 and the most recent update taking place on September 28th, 2020."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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