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
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
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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 |
Trial Details
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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 |
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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. |
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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 |
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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 |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Rheumatoid Arthritis |
| Study Website: | View Trial Website |
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.
