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Arthritis, RheumatoidNCT05375942

This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry

An observational study of Arthritis, Rheumatoid, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Inflectra
How many people
255 participants
Where
1 siteUnited States
Study dates
11 Nov 2022to 11 Nov 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This is a retrospective analysis of an existing database of patient encounters from the CorEvitas RA Registry

Who may be able to join

  • Be at least 18 years of age
  • Have been diagnosed with RA by a rheumatologist
  • Have initiated treatment with Inflectra
  • Had assessment of effectiveness in patients who have at least one follow up visit.

Who cannot join

  • No additional exclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pfizer

    Collegeville, Pennsylvania, 19426

Other trials in United States

About this study

Official title: Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra

This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.

Being tested
Inflectra
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InflectraDrug

    1. To describe the characteristics of patients newly initiated on Inflectra.
  • InflectraDrug

    1. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry.
Study groups in NCT05375942
Study groupRoleWhat they receive
characteristics of patients newly initiated on InflectraNot described
Receives: Drug: Inflectra
outcomes after initiating InflectraNot described
Receives: Drug: Inflectra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation

    Clinical disease activity index (CDAI) was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 millimeter (mm) visual analogue scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved LDA had CDAI score less than or equal to (<=)10. Participants with moderate or high disease activity (CDAI greater than [>]10) at baseline were analyzed for this outcome measure.

    Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)

Secondary outcomes (8)
  1. Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation

    CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved clinical remission had a CDAI score <=2.8. Participants with low, moderate or high disease activity (CDAI>2.8) at baseline were analyzed for this outcome measure.

    Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  2. Change From Baseline in CDAI at 6 Months After Inflectra Initiation

    CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <2.8 indicated disease remission, 2.8 to <10 indicated low disease activity, 10 to <22 indicated moderate disease activity, and >=22 indicated high disease activity.

    Measured: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  3. Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation

    HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.

    Measured: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  4. Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation

    Participant pain was measured on a VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).

    Measured: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  5. Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation

    Participant fatigue was measured on a VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

    Measured: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  6. Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation

    mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

    Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  7. Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation

    mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

    Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)

  8. Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation

    mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

    Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start11 Nov 2022
  3. Primary completion11 Nov 2022
  4. Study completion11 Nov 2022

Resources

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
Retrospective
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375942
Sponsor's protocol ID
C1231007
Status last verified
Oct 2023
First submitted
11 May 2022
Last updated
12 Apr 2024
Data monitoring committee
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid, run by Pfizer 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 4 inclusion and 1 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 12 Apr 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?

Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation (time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)). 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 12 Apr 2024.

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