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The ArthritisPower Wearable Study

Study Purpose

Rheumatoid arthritis patients being seen at one of the participating clinical sites in a U.S. network of community rheumatology practices who are starting treatment on adalimumab or upadacitinib will be enrolled into a 24-week study combining clinical data from physicians, self-reported patient outcomes from the ArthritisPower registry app, and activity and sleep data from a Fitbit wearable device. The primary objective of this study is: • Evaluate longitudinal associations between biometric sensor data (activity and sleep measures), physician-derived data (including clinical disease activity index (CDAI), Rheumatoid Factor (RF) lab results and other relevant biomarkers, current medications and disease duration), and patient-reported outcomes (PROs) (including PROMIS pain interference, physical function, fatigue, sleep disturbance, satisfaction with participation in discretionary social activities, and anxiety). The secondary objectives of this study are as follows:

  • - Explore the reliability and predictive validity of biometric sensor data to classify changes in RA disease activity and associated symptoms, including PROs.
  • - To assess adherence and predictors of adherence with use of biometric sensor.
  • - Assess/track changes in upadacitinib and adalimumab patients using combined physician, PRO and biosensor data.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05603806
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Global Healthy Living Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ben Nowell, PhD
Principal Investigator Affiliation Global Healthy Living Foundation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

: RA new treatment starts

Adult rheumatoid arthritis patients starting treatment on adalimumab or upadacitinib

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Global Healthy Living Foundation, Upper Nyack, New York

Status

Recruiting

Address

Global Healthy Living Foundation

Upper Nyack, New York, 10960

Site Contact

Ben Nowell, Phd

[email protected]

845-348-0400 #105

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