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

Study Overview
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Brief Summary
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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
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This study population was chosen from a non-probability sample.

Official Title
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Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions

Conditions
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Arthritis, Psoriatic

Intervention / Treatment
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* Biological: Remicade (Infliximab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remicade (Infliximab)<br>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. | Biological: Remicade (Infliximab)<br>* Induction infusions of Remicade will be administered 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.<br>* Other names: SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time Interval Between Infusions During Maintenance Therapy | 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. | Up to 24 months | 
| Median Time Interval Between Infusions During Maintenance Therapy | 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. | Up to 24 months | 
| Average Dose During Induction Therapy and Subsequent Maintenance Therapy | 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). | Up to 24 Months | 
| Median Dose During Induction Therapy and Subsequent Maintenance Therapy | 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). | Up to 24 Months | 
| Average Overall Dose of All Infusions Per Participant | The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg. | Up to 24 Months | 
| Median Dose of All Infusions Per Participant | The median dose of all infusions among all Infliximab-naive participants measured in mg/kg. | Up to 24 Months |