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

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: August 12, 2014
Last verified: August 2014

July 25, 2008
August 12, 2014
October 2006
June 2010   (final data collection date for primary outcome measure)
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).

Mean number of therapies that are applied as maintenance therapy or as episodic treatment within the observation period. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00725452 on ClinicalTrials.gov Archive Site
  • 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.
  • Mean and median interval between infusions within the observation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Average and median dosage as well as total dose of Remicade in PS within the observation period. [ Time Frame: Maximum 2 years ] [ Designated as safety issue: No ]
  • Outcome - measured body surface area (BSA) affected prior to and after treatment with infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety: Number of adverse events (special attention to hepatotoxicity and tuberculosis reactivation) occurred during treatment with Remicade within the observation period. [ Time Frame: Maximum of 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)
Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy

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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Psoriasis
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
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.
Intervention: Biological: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2010
June 2010   (final data collection date for primary outcome measure)

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)).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00725452
P04900
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Centocor, Inc.
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP