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Completed

NCT Number: NCT05375942

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Collegeville, Pennsylvania, 19426, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • No additional exclusion criteria

Treatment and study plan

Inflectra

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

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation

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

    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.

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

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

    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).

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

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

    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).

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

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

    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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
Apr 12, 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.

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