Clinical trial NCT05375942: This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry
Official title: Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective analysis of an existing database of patient encounters from the CorEvitas RA Registry

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation
timeFrame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Secondary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation
timeFrame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Change From Baseline in CDAI at 6 Months After Inflectra Initiation
timeFrame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation
timeFrame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation
timeFrame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation
timeFrame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation
timeFrame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation
timeFrame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
measure: Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation
timeFrame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Other outcomes:
Locations:
city: Collegeville
country: United States
facility: Pfizer
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: