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

NCT04512573 | Completed

• 1 other identifier: RA-100-POWER
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Patient Reported: Duration Morning Joint Stiffness

  every 6 months for 10 years

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

  every 6 months for 10 years

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

  every 6 months for 10 years

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

  every 6 months for 10 years

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

  every 6 months for 10 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The following eligibility criteria are designed to select patients for whom study assessments are deemed appropriate. Patients must have attained at least the locally recognized age of consent and provide written or electronic informed consent to participate

You may qualify if:

• 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.

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

Corrona, LLC

Waltham, Massachusetts, 02451, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 13, 2020
• Study Start: May 21, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: December 4, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)