We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725452
First Posted: July 30, 2008
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 ]

    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 ]
  • Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum 2 years ]
  • Mean Dose of Infliximab [ Time Frame: Maximum 2 years ]
  • Median Dose of Infliximab [ Time Frame: Maximum 2 years ]
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725452     History of Changes
Other Study ID Numbers: P04900
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: June 13, 2011
Results First Posted: September 2, 2011
Last Update Posted: July 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents