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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725452
First received: July 25, 2008
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Psoriasis
Biological: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab [ Time Frame: Maximum 2 years ] [ Designated as safety issue: No ]

    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:
  • Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum 2 years ] [ Designated as safety issue: No ]
  • Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum 2 years ] [ Designated as safety issue: No ]
  • Mean Dose of Infliximab [ Time Frame: Maximum 2 years ] [ Designated as safety issue: No ]
  • Median Dose of Infliximab [ Time Frame: Maximum 2 years ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab [ Time Frame: Baseline and Infusion 9 ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: October 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other Names:
  • Remicade
  • SCH 215596

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.

Criteria

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)).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725452     History of Changes
Other Study ID Numbers: P04900
Study First Received: July 25, 2008
Results First Received: June 13, 2011
Last Updated: February 13, 2014
Health Authority: Austria: Not Required

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014