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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Psoriasis

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00725452

P04900

Details and patient eligibility

About

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

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)).

Trial design

26 participants in 1 patient group

Infliximab

Description:

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.

Treatment:

Biological: Infliximab