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

Arthritis, Psoriatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725296
• Other study ID #: P04264
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 13, 2015
• Start date: December 2004
• Est. completion date: July 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: No HA submission required
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Biological:
• Remicade (Infliximab)
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No