Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)

Spondylitis, Ankylosing Clinical Trial

Official title:

Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725543
• Other study ID #: P04044
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 28, 2015
• Start date: June 2004
• Est. completion date: June 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Not Required
• Study type: Observational

Clinical Trial Summary

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.

Exclusion Criteria:

• Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.

• Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).

• Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• Infliximab
Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of 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 Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy		Maximum of 24 months	No
Primary	Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy		Maximum of 24 months	No
Primary	Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy		Maximum of 24 months.	No
Primary	Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy		Maximum of 24 months.	No
Primary	Mean Remicade Dose Per Participant		Maximum of 24 months	No
Primary	Median Remicade Dose Per Participant		Maximum of 24 months	No