Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)

Psoriasis Clinical Trial

Official title:

Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725452
• Other study ID #: P04900
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: July 15, 2015
• Start date: October 2006
• Est. completion date: June 2010

Study information

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

Clinical Trial Summary

Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).

Exclusion Criteria:

• According to the European SPC:

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

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

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

• Subjects with elevated liver enzymes (>5 upper limit of normal (ULN)).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Infliximab
Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals 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	Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab	The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days).; Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks).; Episodic Therapy: given out of time frame (> 12 weeks).	Maximum 2 years	No
Secondary	Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy		Maximum 2 years	No
Secondary	Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy		Maximum 2 years	No
Secondary	Mean Dose of Infliximab		Maximum 2 years	No
Secondary	Median Dose of Infliximab		Maximum 2 years	No
Secondary	Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab	BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.	Baseline and Infusion 9	No