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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Inflectra; Drug: Inflectra

• Study Type: Observational
• Enrollment (Actual): 255

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Collegeville, Pennsylvania, United States, 19426
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
characteristics of patients newly initiated on Inflectra	Drug: Inflectra; 1. To describe the characteristics of patients newly initiated on Inflectra.; Drug: Inflectra; 2. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry.
outcomes after initiating Inflectra	Drug: Inflectra; 1. To describe the characteristics of patients newly initiated on Inflectra.; Drug: Inflectra; 2. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months (from the retrospective data collected from the CorEvitas RA registry)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months (from the retrospective data collected from the CorEvitas RA registry)
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.	Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
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.	Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
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).	Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
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.	Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
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).	6 Months (from the retrospective data collected from the CorEvitas RA registry)
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).	6 Months (from the retrospective data collected from the CorEvitas RA registry)
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).	6 Months (from the retrospective data collected from the CorEvitas RA registry)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Tumor Necrosis Factor Inhibitors; Infliximab
• Other Study ID Numbers: C1231007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.