Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Infliximab (Biological)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction TherapyMedian Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy Mean Remicade Dose Per Participant Median Remicade Dose Per Participant
Secondary outcome: Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade TherapyNumber and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
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 Summary of Product Characteristics (SPC).
Locations and Contacts
Additional Information
Starting date: March 2004
Last updated: October 29, 2014
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