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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:  NCT00725621
Date of registration: 25/07/2008
Prospective Registration: No
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)
Scientific title: Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy
Date of first enrolment: March 2004
Target sample size: 516
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00725621
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Austria
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Severe RA (indication according to Austrian labeling).

Exclusion Criteria:

- According to Summary of Product Characteristics (SPC).



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: Infliximab
Primary Outcome(s)
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy [Time Frame: Maximum of 102 weeks]
Mean Remicade Dose Per Participant [Time Frame: Maximum of 102 weeks]
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [Time Frame: Maximum of 16 weeks]
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy [Time Frame: Maximum of 102 weeks]
Median Remicade Dose Per Participant [Time Frame: Maximum of 102 weeks]
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [Time Frame: Maximum of 16 weeks]
Secondary Outcome(s)
Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy [Time Frame: 24 months maximum]
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS [Time Frame: 24 months maximum]
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) [Time Frame: 24 months maximum]
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) [Time Frame: 24 months maximum]
Secondary ID(s)
P03756
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor, Inc.
Ethics review
Results
Results available: Yes
Date Posted: 04/08/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00725621
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