Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
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
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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 Schering-Plough:
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:
|
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: | Vice President, Late Stage Development Group Leader, 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: | August 2, 2011 |
| 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 May 23, 2013