Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| characteristics of patients newly initiated on Inflectra |
| ||
| outcomes after initiating Inflectra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflectra | Drug | 1. To describe the characteristics of patients newly initiated on Inflectra. |
|
| 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) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This is a retrospective analysis of an existing database of patient encounters from the CorEvitas RA Registry
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Collegeville | Pennsylvania | 19426 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2023 | Oct 13, 2023 |
Not provided
Not provided
Not provided
Not provided
| Inflectra | Drug | 2. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry. |
|
| 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) |
| Participants With 6 Month Follow-up (Cohort 2) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
All eligible participants whose data was observed in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data is presented for participants evaluable in Cohort 1 and 2. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Data is presented for participants evaluable in Cohort 1 and 2. | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Data is presented for participants evaluable in Cohort 1 and 2. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
|
| |||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | Millimeter | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Millimeter | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| ||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
|
Not applicable for this study as safety data was not planned to be collected during the study
In the study, individual participant data were not retrieved or validated, and it was not possible to link (ie, identify a potential association between) a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (AE) (ie, identifiable participant, identifiable reporter, a suspect product, and event) could not be met.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Participants With 6-Months Follow-up (Cohort 2) | All participants diagnosed with RA who were Inflectra initiators in real world, who met inclusion criteria, and had CDAI available at Baseline and at 6-months follow-up visit. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2022 | Oct 13, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
| Male |
|
| Cohort 2 |
|
|
| Non-white |
|
| Not reported |
|
| Cohort 2 |
|
|
|
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
|
|