Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)NCT04512573
Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)
An observational study of Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER), run by CorEvitas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to 31 Aug 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Study completion, an average of 10 years
Secondary outcomes (14)
Patient Reported: Duration Morning Joint Stiffness
Measured: every 6 months for 10 years
Patient Reported: Routine Assessment of Patient Index Data 3 (RAPID3)
Measured: every 6 months for 10 years
Patient Reported: PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a
Measured: every 6 months for 10 years
Patient Reported: Compliance Questionnaire for Rheumatology (5-item)
Measured: every 6 months for 10 years
Patient Reported: Treatment Satisfaction Questionnaire for Medication (9-item)
Measured: every 6 months for 10 years
Patient Reported: PROMIS Anxiety
Measured: every 6 months for 10 years
Patient Reported: PROMIS Depression
Measured: every 6 months for 10 years
Patient Reported: PROMIS Emotional Support
Measured: every 6 months for 10 years
Patient Reported: PROMIS Pain Intensity
Measured: every 6 months for 10 years
Patient Reported: PROMIS Pain Interference
Measured: every 6 months for 10 years
Patient Reported: PROMIS Physical Function
Measured: every 6 months for 10 years
Patient Reported: PROMIS Sleep Disturbance
Measured: every 6 months for 10 years)
Patient Reported: PROMIS Satisfaction with Participation in Discretionary Social Activities (Time Frame: every 6 months for 10 years)
Measured: every 6 months for 10 years
Patient Reported: PROMIS Ability to Participate in Social Roles and Activities
Measured: every 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start21 May 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512573
- Sponsor's protocol ID
- RA-100-POWER
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2020
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)
- ClinicalTrials.gov ID
- NCT04512573
- Acronym / sponsor ID
- RA-100-POWER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 21 May 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
14 secondary outcomes
Patient Reported: Duration Morning Joint Stiffness
Time frame: every 6 months for 10 years
Patient Reported: Routine Assessment of Patient Index Data 3 (RAPID3)
Time frame: every 6 months for 10 years
Patient Reported: PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a
Time frame: every 6 months for 10 years
Patient Reported: Compliance Questionnaire for Rheumatology (5-item)
Time frame: every 6 months for 10 years
Patient Reported: Treatment Satisfaction Questionnaire for Medication (9-item)
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Anxiety
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Depression
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Emotional Support
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Pain Intensity
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Pain Interference
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Physical Function
Time frame: every 6 months for 10 years
Patient Reported: PROMIS Sleep Disturbance
Time frame: every 6 months for 10 years)
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
Patient Reported: PROMIS Ability to Participate in Social Roles and Activities
Time frame: every 6 months for 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER), run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns, effectiveness, and safety of JAK inhibitors currently used in the management of RA (time frame: Through Study completion, an average of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.