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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT05603806
Eligibility Criteria:
Inclusion Criteria:
* Age 19 and above who are adults (i.e., the age of majority where they reside)
* Diagnosis of RA by a physician (as indicated by survey screening questions)
* Currently being seen by a U.S. rheumatologist
* Starting on the day of enrollment (with no prior use ever) or soon-to-initiate (i.e. in the next 28 days) upadacitinib or adalimumab for RA
* Ability to walk without the use of assistive devices;
* Have access to a computer or smartphone to take health assessments and a survey;
* Already own a smartphone (iPhone or Android); iPhone 4S and later or Android 4.3 and later
* Are willing to join the ArthritisPower patient registry;
* Are willing to download the ArthritisPower app;
* Are willing to contribute daily and weekly ePROs for at least at 89 days, and health activity tracker data for at least 84 days (lead-in period minimum of 5 days plus main study period 84 days). Some participants may contribute data more than 89 days if there was a lag in receiving their medication and hence later medication start date;
* Are willing to wear the smartwatch while sleeping;
* Are willing to complete the 7-day run-in requirements (i.e. completing daily PRO assessments for at least 5 of 7 days);
* Have started their medication within 30 days of enrolling in the study (i.e. enrolling in ArthritisPower)
* Will not be out of internet access (wifi and/or mobile data) for 4 or more consecutive days during the study; and
* Willing to be contacted by e-mail/text message and/or phone by the study coordinator if participants fail to adhere to the study Protocol or for any study related assistance as required.
* Clinician must collect a CDAI (including the raw scores for the four components - patient global, physician global and tender and swollen joint count) on day of enrollment.
* CDAI must be \>10
* Must have rheumatoid and CCP antibody lab results available, or collect those labs (as part of standard of care during the enrollment visit) if not available
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05603806
Study Brief:
Protocol Section:
NCT05603806