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:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT04713995
Eligibility Criteria:
Inclusion Criteria:
* ICD-10 disease code or diagnosis for AxSpA
* Confirmed diagnosis of AxSpA, based on ASDAS criteria including both non-radiographic axial spondyloarthritis and ankylosing spondylitis
* HLA-B27 positive
* Signed informed consent prior to any study-specific procedures are performed
* Females and males aged 18 years or older
* Able to read, speak and understand English
* Willing and able to use the at-home collection kits and mail in pre-paid mailers
* Willing and able to use a smartphone app or web app to answer surveys
* Willing and able to make and keep/travel to a local lab visit for blood collection
* Willing and able to follow the study instructions, as described in the recruitment letter
Exclusion Criteria:
* Unable or unwilling to use Viome's App on an iPhone or Android smartphone
* Not HLA-B27 positive
* No diagnosis for AxSpA/AS
* Pregnant or nursing
* Other diagnosis of arthritis (rheumatoid, osteoarthritis, psoriatic arthritis, psoriatic spondyloarthritis)
* IBD/Crohn's disease/ulcerative colitis
* Use of antibiotics or Sulfasalazine within the past 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04713995
Study Brief:
Protocol Section:
NCT04713995