Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)

Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER) Clinical Trial

Official title:

Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512573
• Other study ID #: RA-100-POWER
• Status: Completed
• Start date: May 21, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: CorEvitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, real-world observational study in which patients with RA who are initiating treatment with a JAK inhibitor medication will self-report disease activity and treatment satisfaction measures using their own web-enabled device such as a smartphone. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

A patient MUST satisfy all of the following criteria to be eligible for enrollment into the POWER study:

1. 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.

2. 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.

3. Patient is literate in English.

4. Patients provides consent for their data to be included in ArthritisPower™ registry in addition to providing consent to participate in the POWER study itself.

5. In conjunction with POWER registration:

1. 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)

2. 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)

Locations

Country	Name	City	State
United States	Corrona, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CorEvitas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns, effectiveness, and safety of JAK inhibitors currently used in the management of RA	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.	Through Study completion, an average of 10 years
Secondary	Patient Reported: Duration Morning Joint Stiffness		every 6 months for 10 years
Secondary	Patient Reported: Routine Assessment of Patient Index Data 3 (RAPID3)		every 6 months for 10 years
Secondary	Patient Reported: PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a		every 6 months for 10 years
Secondary	Patient Reported: Compliance Questionnaire for Rheumatology (5-item)		every 6 months for 10 years
Secondary	Patient Reported: Treatment Satisfaction Questionnaire for Medication (9-item)		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Anxiety		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Depression		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Emotional Support		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Pain Intensity		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Pain Interference		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Physical Function		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Sleep Disturbance		every 6 months for 10 years)
Secondary	Patient Reported: PROMIS Satisfaction with Participation in Discretionary Social Activities (Time Frame: every 6 months for 10 years)		every 6 months for 10 years
Secondary	Patient Reported: PROMIS Ability to Participate in Social Roles and Activities		every 6 months for 10 years