Arthritis, RheumatoidNCT05375942
This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry
An observational study of Arthritis, Rheumatoid, run by Pfizer at 1 site in United States.
Trial summary
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Inflectra
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to 11 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective analysis of an existing database of patient encounters from the CorEvitas RA Registry
Who may be able to join
- 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.
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Inflectra
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InflectraDrug
- To describe the characteristics of patients newly initiated on Inflectra.
InflectraDrug
- To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry.
| Study group | Role | What they receive |
|---|---|---|
| characteristics of patients newly initiated on Inflectra | Not described Receives: Drug: Inflectra | |
| outcomes after initiating Inflectra | Not described Receives: Drug: Inflectra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start11 Nov 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375942
- Sponsor's protocol ID
- C1231007
- Status last verified
- Oct 2023
- First submitted
- 11 May 2022
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra
- ClinicalTrials.gov ID
- NCT05375942
- Acronym / sponsor ID
- C1231007
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| characteristics of patients newly initiated on Inflectra | – | Drug: Inflectra |
| outcomes after initiating Inflectra | – | Drug: Inflectra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective analysis of an existing database of patient encounters from the CorEvitas RA Registry
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- No additional exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflectra1. To describe the characteristics of patients newly initiated on Inflectra. | Drug | characteristics of patients newly initiated on Inflectra |
| Inflectra2. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry. | Drug | outcomes after initiating Inflectra |
Primary outcome
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.
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.