Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)

Completed

• Conditions: Arthritis, Psoriatic
• Interventions: Biological: Remicade (Infliximab)

• Registration Number: NCT00725296
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Description

This study population was chosen from a non-probability sample.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-01
• Results First Submitted QC: 2011-07-01
• Results First Posted: 2011-07-29
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

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Exclusion Criteria

• All according to contraindications in the label especially:

  • Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  • Participants with moderate or severe heart failure (NYHA class III/IV).
  • Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remicade (Infliximab)	Remicade (Infliximab)	Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs will receive induction infusions of Remicade at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians. Whole observation period cannot exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in the Summary of Product Characteristics (SPC) is taken into consideration.

Primary Outcome Measures

Name	Time	Method
Mean Time Interval Between Infusions During Maintenance Therapy	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	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	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	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	Up to 24 Months	The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Median Dose of All Infusions Per Participant	Up to 24 Months	The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.