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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00724243
Date of registration: 25/07/2008
Prospective Registration: No
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)
Scientific title: Remicade Treatment Registry in Rheumatoid Arthritis I
Date of first enrolment: January 2006
Target sample size: 33
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00724243
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Slovakia
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject must have been given patient leaflet,

- Subject must not have ever received infliximab at the time of registration,

- Subject must be a good candidate for infliximab as per Summary of Product
Characteristics

- Subject must sign the approved consent form

Exclusion Criteria:



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment [Time Frame: Baseline, Week 14, and Week 54]
Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria [Time Frame: Week 14 and Week 54]
Secondary Outcome(s)
Secondary ID(s)
P04741
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/02/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00724243
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