Clinical Trial: Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
Brief Summary: This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).
Detailed Summary: This study population was chosen from a non-probability sample.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
- Mean Time Interval Between Infusions During Maintenance Therapy [ Time Frame: Up to 24 months ]The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
- Median Time Interval Between Infusions During Maintenance Therapy [ Time Frame: Up to 24 months ]The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
- Average Dose During Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Up to 24 Months ]The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
- Median Dose During Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Up to 24 Months ]The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
- Average Overall Dose of All Infusions Per Participant [ Time Frame: Up to 24 Months ]The average overall dose of all infusions among a
Original Primary Outcome:
- Mean and median interval between dosages within the observation period. [ Time Frame: Maximum of 24 months. ]
- Average and median dosage as well as total dose of Remicade in PsA within the observation period (maximum of 9 infusions). [ Time Frame: Maximum of 24 months. ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: July 25, 2008
Date Started: December 2004
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015