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Completed

NCT Number: NCT04512573

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Corrona, LLC

Waltham, Massachusetts, 02451, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patterns, effectiveness, and safety of JAK inhibitors currently used in the management of RA

    Time frame: Through Study completion, an average of 10 years

    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.

Secondary outcomes

  1. Patient Reported: Duration Morning Joint Stiffness

    Time frame: every 6 months for 10 years

  2. Patient Reported: Routine Assessment of Patient Index Data 3 (RAPID3)

    Time frame: every 6 months for 10 years

  3. Patient Reported: PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a

    Time frame: every 6 months for 10 years

  4. Patient Reported: Compliance Questionnaire for Rheumatology (5-item)

    Time frame: every 6 months for 10 years

  5. Patient Reported: Treatment Satisfaction Questionnaire for Medication (9-item)

    Time frame: every 6 months for 10 years

  6. Patient Reported: PROMIS Anxiety

    Time frame: every 6 months for 10 years

  7. Patient Reported: PROMIS Depression

    Time frame: every 6 months for 10 years

  8. Patient Reported: PROMIS Emotional Support

    Time frame: every 6 months for 10 years

  9. Patient Reported: PROMIS Pain Intensity

    Time frame: every 6 months for 10 years

  10. Patient Reported: PROMIS Pain Interference

    Time frame: every 6 months for 10 years

  11. Patient Reported: PROMIS Physical Function

    Time frame: every 6 months for 10 years

  12. Patient Reported: PROMIS Sleep Disturbance

    Time frame: every 6 months for 10 years)

  13. 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

  14. Patient Reported: PROMIS Ability to Participate in Social Roles and Activities

    Time frame: every 6 months for 10 years

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.