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

Completed

• Conditions: Psoriasis
• Interventions: Biological: Infliximab

• Registration Number: NCT00725452
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-13
• Results First Submitted QC: 2011-08-02
• Results First Posted: 2011-09-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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).

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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)).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infliximab	Infliximab	Subjects with plaque psoriasis will receive 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.

Primary Outcome Measures

Name	Time	Method
Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab	Maximum 2 years	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).

Secondary Outcome Measures

Name	Time	Method
Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy	Maximum 2 years
Median Dose of Infliximab	Maximum 2 years
Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab	Baseline and Infusion 9	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.
Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy	Maximum 2 years
Mean Dose of Infliximab	Maximum 2 years