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

NCT05375942 | Completed Results

• 1 other identifier: C1231007
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation

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

• Change From Baseline in CDAI at 6 Months After Inflectra Initiation

  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

  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

  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

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

Study Arms (2)

characteristics of patients newly initiated on Inflectra

Drug: Inflectra

outcomes after initiating Inflectra

Drug: Inflectra

Interventions

Inflectra DRUG

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

characteristics of patients newly initiated on Inflectra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Collegeville, Pennsylvania, 19426, United States

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: November 11, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)