A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

Merck Sharp & Dohme LLC728 enrolled

Overview

This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.

Study Type

OBSERVATIONAL

Enrollment

728

Conditions

Rheumatoid Arthritis

Interventions

InfliximabBIOLOGICAL

Infliximab used in line with current clinical practice and local guidelines.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has been diagnosed with RA * Physician has decided, with the subject's consent, to begin treatment with infliximab * Written informed consent form signed by both the subject and the physician. Exclusion Criteria: * Subjects who have previously been exposed to infliximab

Outcomes

Primary Outcomes

Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.

Time frame: At Baseline

Baseline Raw DAS28 by Time Since Diagnosis

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.

Time frame: At Baseline

Baseline Raw DAS28 by Gender

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.

Time frame: At Baseline

Baseline Raw DAS28 by Country of Residence

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.

Time frame: At Baseline

Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.

Time frame: At Baseline

Data from ClinicalTrials.gov

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