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

Merck Sharp & Dohme LLC178 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

178

Conditions

Arthritis, Psoriatic

Interventions

Remicade (Infliximab)BIOLOGICAL

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Up to 24 Months

Data from ClinicalTrials.gov

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