- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512573
Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)
Study Overview
Status
Detailed Description
The primary objective of this study is to analyze self-reported disease activity outcomes and treatment satisfaction measures in the real world using a bring-your-own-device approach for patients with rheumatoid arthritis who are initiating a JAKi medication. An exploratory objective is to assess the feasibility of using smartphone or web-based data collection to expand upon the insights gained through the Corrona RA Registry which uses a traditional site-based approach.
POWER is a prospective, non-interventional study that will collect structured real-world data from patients with RA using a patient-centered mobile health application called ArthritisPower™. Patients planning to start treatment with a JAKi medication will self-report disease activity and treatment satisfaction through their first 3 months of therapy using their own web-enabled device such as a smartphone or computer.
Patients will be recruited from the Corrona RA Registry at the time of a routine clinical encounter.
After POWER registration, the remainder of the study is carried out using an automated data collection schedule via the web-based ArthritisPower™ application. Patients may complete assessments using a web browser or by downloading the free ArthritisPower™ application to a smartphone or tablet.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Waltham, Massachusetts, United States, 02451
- Corrona, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
A patient MUST satisfy all of the following criteria to be eligible for enrollment into the POWER study:
- Patient is currently participating in the Corrona RA Registry OR is eligible to participate and enrolls into the RA Registry prior to POWER study registration.
- Patient is willing and able to complete online weekly surveys about their RA using their own computer, tablet,or smartphone and have a valid email address.
- Patient is literate in English.
- Patients provides consent for their data to be included in ArthritisPower™ registry in addition to providing consent to participate in the POWER study itself.
In conjunction with POWER registration:
- A Corrona RA Registry Enrollment or Follow-up visit is conducted (includes both the Provider and Subject questionnaires and most recent Lab/Imaging Results if available)
Patient is newly prescribed* or receives their first dose of one of the following JAK-inhibitor medications: OLUMIANT® (baricitinib), RINVOQ™ (upadacitinib), or XELJANZ / XELJANZ XR® (tofacitinib)**, or any other JAK inhibitor approved during the study period.
The decision to treat with a new therapy must precede the decision to recruit the patient into this study. Prior use of a JAK-inhibitor medication does not exclude a patient from enrollment.
- Patients switching to and from either formula of tofacitinib (Xeljanz 5 mg BID or the "once daily" XR 11 mg version) do not qualify for the POWER study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patterns, effectiveness, and safety of JAK inhibitors currently used in the management of RA
Time Frame: Through Study completion, an average of 10 years
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To analyze self-reported disease activity and treatment satisfaction for patients with RA in the real world at the time of initiation with a JAK inhibitor medication.
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Through Study completion, an average of 10 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Reported: Duration Morning Joint Stiffness
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: Routine Assessment of Patient Index Data 3 (RAPID3)
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: Compliance Questionnaire for Rheumatology (5-item)
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: Treatment Satisfaction Questionnaire for Medication (9-item)
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Anxiety
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Depression
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Emotional Support
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Pain Intensity
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Pain Interference
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Physical Function
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Sleep Disturbance
Time Frame: every 6 months for 10 years)
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every 6 months for 10 years)
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Patient Reported: PROMIS Satisfaction with Participation in Discretionary Social Activities (Time Frame: every 6 months for 10 years)
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Patient Reported: PROMIS Ability to Participate in Social Roles and Activities
Time Frame: every 6 months for 10 years
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every 6 months for 10 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA-100-POWER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)
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Clínica de Artritis TempranaInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranCompletedRheumatoid Arthritis | Patient Reported Outcomes | Musculoskeletal UltrasoundMexico