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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Infliximab

• Registration Number: NCT00705289
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-03
• Results First Submitted QC: 2010-05-12
• Results First Posted: 2010-06-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 728

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.

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Exclusion Criteria

• Subjects who have previously been exposed to infliximab

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA Subjects/ Infliximab 3 mg/kg	Infliximab	Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).

Primary Outcome Measures

Name	Time	Method
Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age	At Baseline	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.
Baseline Raw DAS28 by Time Since Diagnosis	At Baseline	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.
Baseline Raw DAS28 by Gender	At Baseline	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.
Baseline Raw DAS28 by Country of Residence	At Baseline	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.
Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy	At Baseline	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.