Skip to main content
OpenTrials
Completed

NCT Number: NCT00725452

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)).

Treatment and study plan

Infliximab

Biological

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.

Other names: Remicade, SCH 215596

Primary outcomes

  1. Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab

    Time frame: 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 outcomes

  1. Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy

    Time frame: Maximum 2 years

  2. Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy

    Time frame: Maximum 2 years

  3. Mean Dose of Infliximab

    Time frame: Maximum 2 years

  4. Median Dose of Infliximab

    Time frame: Maximum 2 years

  5. Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Centocor, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2008
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.