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:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00725452

First received: July 25, 2008

Last updated: August 2, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 25, 2008
Last Updated Date	August 2, 2011
Start Date ^ICMJE	October 2006
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 2, 2011)	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).
Original Primary Outcome Measures ^ICMJE (submitted: July 25, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00725452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 2, 2011)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: July 25, 2008)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)(COMPLETED)
Official Title ^ICMJE	Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.
Condition ^ICMJE	Psoriasis
Intervention ^ICMJE	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
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	26
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00725452
Other Study ID Numbers ^ICMJE	P04900
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Centocor, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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