Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-25 @ 4:45 AM
NCT ID:
NCT05080218
Eligibility Criteria:
Inclusion Criteria: \*Patients must meet all of the inclusion criteria at the time of screening\*
* Must have a rheumatology provider diagnosis of one or more of the following autoimmune inflammatory conditions:
* Rheumatoid arthritis or adults previously diagnosed with Juvenile idiopathic arthritis (analyzed as a single category)
* Psoriatic arthritis (PsA), Ankylosing spondylitis (ASp), or other Spondyloarthritis (SpA)
* Must have completed the 2-dose regimen of either of the two mRNA COVID-19 vaccines more than 28 days previous to enrollment
* Must be scheduled for an additional dose of mRNA COVID-19 vaccination booster (or with plans to schedule booster) within the next 30 days
* Must have a cell phone capable of receiving text messages, and/or a personal email address
* Currently receiving one of the medications described in Table 1
* Must be on stable immunomodulatory therapy for 8 weeks (with no dose changes, or interruptions \> 2 weeks) prior to study enrollment. This would include both the qualifying immunomodulatory drug listed in Table 2, as well as any background immunomodulatory therapies (e.g. methotrexate, leflunomide) or glucocorticoids.
* Must be 18 years of age or older
* Must live in the United States.
Exclusion Criteria:
* • Already received a non-mRNA COVID-19 vaccine dose (J\&J)
* Any use in the past 90 days of a monoclonal antibody against COVID-19 (e.g., bamlanivimab, casirivimab, imdevimab)
* Any known contraindication to COVID-19 vaccination, including allergic reaction to prior COVID-19 vaccination, and severe allergy to vaccine components (e.g., pegloticase)
* Known HIV/AIDS or any other immunodeficient condition
* Use of immunomodulatory therapy for any non-rheumatologic indication (e.g., organ transplantation)
* Currently receiving radiation or chemotherapy for any type of malignancy.
* Receipt of any immunization other than COVID-19 within two weeks prior to the COVID-19 vaccine supplemental dose
* Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to \< 1 year)
* Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g., uncontrolled disease flare, uncontrolled comorbidity)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05080218
Study Brief:
Protocol Section:
NCT05080218