Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Infliximab (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the
average Remicade dosage and time span between 9 infusions in subjects with rheumatoid
arthritis (RA)
Clinical Details
Official title: Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy
Study design: Cohort, Prospective
Primary outcome: Average and median dosage as well as total dose of Remicade in RA within the observation period (maximum of 9 infusions).Mean and median interval between dosages within the observation period. Impact of maintenance therapy location - specialized hospital vs extramural infusion centers - on endpoints mentioned above.
Secondary outcome: Disease progression specified by time period between onset of disease and onset of Remicade therapy and number and kind of previous therapies (DMARDS).Impact of maintenance therapy location on patient's quality of life improvement, measured by SF-36 questionnaire.
Detailed description:
This study population was chosen from a non-probability sample.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Severe RA (indication according to Austrian labeling).
Exclusion Criteria:
- According to SPC
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Coordinating Location, Traiskirchen, Austria; Recruiting
Additional Information
Starting date: March 2004
Ending date: September 2013
Last updated: February 11, 2009
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