Status:
COMPLETED
Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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)).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00725452
Start Date
October 1 2006
End Date
June 1 2010
Last Update
July 28 2015
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