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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05375942
Enrollment
255
Registered
2022-05-17
Start date
2022-11-11
Completion date
2022-11-11
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief summary

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

Interventions

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

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation6 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

MeasureTime frameDescription
Change From Baseline in CDAI at 6 Months After Inflectra InitiationBaseline, 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 InitiationBaseline, 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 InitiationBaseline, 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 Who Achieved Clinical Remission at 6 Months After Inflectra Initiation6 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.
Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation6 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 Initiation6 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 Initiation6 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).
Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra InitiationBaseline, 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.

Countries

United States

Participant flow

Recruitment details

Data of participants with Rheumatoid Arthritis (RA) who had initiated Inflectra was retrieved from the CorEvitas RA registry and observed in this retrospective observational study.

Participants by arm

ArmCount
All Participants (Cohort 1)
All participants diagnosed with RA who were Inflectra initiators in real world, who met inclusion criteria, and whose data were observed in this study.
255
Total255

Baseline characteristics

CharacteristicAll Participants (Cohort 1)
Age, Continuous
Cohort 1
64.0 Years
STANDARD_DEVIATION 12.7
Age, Continuous
Cohort 2
63.6 Years
STANDARD_DEVIATION 13.3
Race/Ethnicity, Customized
Cohort 1
Non-white
62 Participants
Race/Ethnicity, Customized
Cohort 1
Not reported
1 Participants
Race/Ethnicity, Customized
Cohort 1
White
192 Participants
Race/Ethnicity, Customized
Cohort 2
Non-white
43 Participants
Race/Ethnicity, Customized
Cohort 2
Not reported
0 Participants
Race/Ethnicity, Customized
Cohort 2
White
133 Participants
Sex: Female, Male
Cohort 1
Female
194 Participants
Sex: Female, Male
Cohort 1
Male
61 Participants
Sex: Female, Male
Cohort 2
Female
138 Participants
Sex: Female, Male
Cohort 2
Male
38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with moderate or high disease activity (CDAI\>10) at baseline.

ArmMeasureValue (NUMBER)
Participants With 6-Months Follow-up (Cohort 2)Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation32.9 Percentage of participants
Secondary

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.

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
Participants With 6-Months Follow-up (Cohort 2)Change From Baseline in CDAI at 6 Months After Inflectra Initiation-1.8 Units on scaleStandard Deviation 10
Secondary

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.

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Participants With 6-Months Follow-up (Cohort 2)Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation-0.0 Units on scaleStandard Deviation 0.4
Secondary

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.

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
Participants With 6-Months Follow-up (Cohort 2)Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation-1.4 MillimeterStandard Deviation 24.4
Secondary

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).

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
Participants With 6-Months Follow-up (Cohort 2)Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation-0.5 MillimeterStandard Deviation 22.4
Secondary

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.

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with moderate or high disease activity (CDAI\>2.8) at baseline.

ArmMeasureValue (NUMBER)
Participants With 6-Months Follow-up (Cohort 2)Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation13.7 Percentage of Participants
Secondary

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).

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with complete information for calculation of mACR.

ArmMeasureValue (NUMBER)
Participants With 6-Months Follow-up (Cohort 2)Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation12.6 Percentage of participants
Secondary

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).

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with complete information for calculation of mACR.

ArmMeasureValue (NUMBER)
Participants With 6-Months Follow-up (Cohort 2)Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation8.4 Percentage of participants
Secondary

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).

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

Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with complete information for calculation of mACR.

ArmMeasureValue (NUMBER)
Participants With 6-Months Follow-up (Cohort 2)Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation4.2 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026