Status:

COMPLETED

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

Lead Sponsor:

CorEvitas

Conditions:

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

Eligibility:

All Genders

18-99 years

Brief 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 satisfactio...

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 21 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 31 2022

    Estimated Enrollment :

    232 Patients enrolled

    Trial Details

    Trial ID

    NCT04512573

    Start Date

    May 21 2020

    End Date

    August 31 2022

    Last Update

    December 4 2024

    Active Locations (1)

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    1

    Corrona, LLC

    Waltham, Massachusetts, United States, 02451