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

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Inflectra

• Registration Number: NCT05375942
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-11-11
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-10
• Results First Submitted: 2023-10-13
• Results First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Results First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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.

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Exclusion Criteria

• No additional exclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
outcomes after initiating Inflectra	Inflectra	-
characteristics of patients newly initiated on Inflectra	Inflectra	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation	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 Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation	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.
Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation	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.
Change From Baseline in CDAI at 6 Months After Inflectra Initiation	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.
Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation	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.
Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation	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).
Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation	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).
Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation	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).
Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation	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).

Trial Locations

Locations (1)

Pfizer; 🇺🇸 Collegeville, Pennsylvania, United States