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PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

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ClinicalTrials.gov Identifier: NCT00527072
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 24, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.

Tracking Information
First Submitted Date  ICMJE September 6, 2007
First Posted Date  ICMJE September 10, 2007
Results First Submitted Date May 28, 2010
Results First Posted Date June 24, 2010
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE July 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) [ Time Frame: Week 10 ]
Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
The primary analysis for the study is the proportion of patients achieving a Physician's Global Assessment (PGA) of minimal (1) or clear (0) at Week 10.
Change History Complete list of historical versions of study NCT00527072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2012)
  • Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10 [ Time Frame: Week 10 ]
    A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.
  • Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26 [ Time Frame: Week 26 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
Some major secondary analyses include the proportion of patients: with PGA of 1 or 0 at Weeks 1, 2, 4, 6, 14, 22, and 26; achieving PASI 50, PASI 75, PASI 90, and PASI 100 at Weeks 10 and 26; achieving a DLQI score of 0 or 1 at Weeks 10 and 26.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
Official Title  ICMJE A Multicenter, Open-label Study to Assess the Efficacy and Safety of Infliximab (REMICADE�) Therapy in Patients With Plaque Psoriasis Who Had an Inadequate Response to Etanercept (ENBREL�)
Brief Summary The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms.
Detailed Description The most common form of psoriasis is plaque-type psoriasis, which is characterized by recurrent flaring of thickened, red, scaly patches of skin. Although psoriasis is usually not life threatening, these physical discomforts combined with the potential psychological effects of the disease may interfere with everyday activities and negatively impact an individual's quality of life. Many therapies are available for psoriasis; however, with limited effectiveness and significant toxicity. Infliximab is an antibody made in a laboratory. Antibodies are proteins that fight other substances in the body that may cause infections or diseases. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is related to the itchy patches of skin (or plaques) of psoriasis. Infliximab stops the TNF from working. Other studies have shown that stopping the TNF may reduce the plaques. To address the unmet medical need for effective chronic therapies, TNFalpha blockers have recently been used to treat patients with moderate to severe plaque psoriasis. Etanercept also works by stopping the TNF, but in a different way than infliximab. This multi-center, open-label study is designed to test whether or not patients with plaque psoriasis who have not responded well to etanercept treatment may benefit from treatment with infliximab. Key effectiveness measurements will include the time to onset of symptom improvement and health-related quality of life. Safety will be assessed throughout the study. Two weeks after their last dose of etanercept, all eligible patients will receive open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Biological: infliximab
Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Study Arms Experimental: 001
infliximabOpen-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Intervention: Biological: infliximab
Publications * Gottlieb AB, Kalb RE, Blauvelt A, Heffernan MP, Sofen HL, Ferris LK, Kerdel FA, Calabro S, Wang J, Kerkmann U, Chevrier M. The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study. J Am Acad Dermatol. 2012 Oct;67(4):642-50. doi: 10.1016/j.jaad.2011.10.020. Epub 2011 Dec 9.

*   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
Actual Enrollment  ICMJE
 (submitted: September 4, 2009)
217
Original Enrollment  ICMJE
 (submitted: September 6, 2007)
210
Actual Study Completion Date October 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have plaque psoriasis despite at least 4 months of treatment with etanercept per current product labeling
  • Have psoriatic target lesions that have a PGA score greater than 1 (minimal) at screening
  • If receiving methotrexate at screening, must have received methotrexate for at least 3 months and at a stable dose of <= 25 mg/week for at least 4 weeks prior to screening
  • If receiving cyclosporine at screening, must have received cyclosporine at a stable dose of <= 5 mg/kg daily for at least 4 weeks prior to screening.

Exclusion Criteria:

  • Have already received infliximab or adalimumab
  • Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product
  • Have a history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
  • Have a concomitant diagnosis or any history of Congestive Heart Failure
  • Are pregnant, nursing, or planning pregnancy
  • Have used systemic corticosteroids within the 4 weeks prior to screening
  • Have used topical corticosteroids or have initiated treatment with other topical therapies that could affect psoriasis or Psoriasis Area and Severity Index (PASI) evaluation (e.g., tar, anthralin, calcipotriene, tazarotene, methoxsalen) within 2 weeks prior to screening
  • Have used new systemic agents/treatments, other than methotrexate, that can affect psoriasis including, but not limited to, immunosuppressants and/or psoralen plus ultraviolet A light (PUVA) within the 4 weeks prior to screening.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00527072
Other Study ID Numbers  ICMJE CR014500
C0168Z04 ( Other Identifier: Centocor Ortho Biotech Services, L.L.C. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centocor Ortho Biotech Services, L.L.C.
Study Sponsor  ICMJE Centocor Ortho Biotech Services, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
PRS Account Centocor Ortho Biotech Services, L.L.C.
Verification Date August 2012

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