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

Rheumatoid Arthritis Clinical Trial

— REMARK  

Official title:

Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705289
• Other study ID #: P04250
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: July 29, 2015
• Start date: December 2005
• Est. completion date: September 2008

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results fr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Baseline	No
Primary	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.	At Baseline	No
Primary	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.	At Baseline	No
Primary	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.	At Baseline	No
Primary	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.	At Baseline	No