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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 October 2017
Main ID:  NCT00705289
Date of registration: 23/06/2008
Prospective Registration: No
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250) REMARK
Scientific title: Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice
Date of first enrolment: December 2005
Target sample size: 728
Recruitment status: Completed
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Key inclusion & exclusion criteria

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

Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Biological: Infliximab
Primary Outcome(s)
Baseline Raw DAS28 by Country of Residence [Time Frame: At Baseline]
Baseline Raw DAS28 by Gender [Time Frame: At Baseline]
Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy [Time Frame: At Baseline]
Baseline Raw DAS28 by Time Since Diagnosis [Time Frame: At Baseline]
Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age [Time Frame: At Baseline]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 10/06/2010
Date Completed:
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