- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527072
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
August 28, 2012 updated by: Centocor Ortho Biotech Services, L.L.C.
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�)
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.
Study Overview
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
Interventional
Enrollment (Actual)
217
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
infliximabOpen-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
|
Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 10
|
Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26
Time Frame: Week 26
|
Week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
September 3, 2012
Last Update Submitted That Met QC Criteria
August 28, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR014500
- C0168Z04 (Other Identifier: Centocor Ortho Biotech Services, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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