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| Sponsor: | Centocor Ortho Biotech Services, L.L.C. |
|---|---|
| Information provided by: | Centocor Ortho Biotech Services, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00527072 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Biological: infliximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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�) |
| Enrollment: | 217 |
| Study Start Date: | July 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
infliximabOpen-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
|
Biological: infliximab
Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Sr. Director, Clinical Research - Medical Affairs, Centocor Inc. |
| ClinicalTrials.gov Identifier: | NCT00527072 History of Changes |
| Other Study ID Numbers: | CR014500, C0168Z04 |
| Study First Received: | September 6, 2007 |
| Results First Received: | May 28, 2010 |
| Last Updated: | May 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
plaque psoriasis psoriasis infliximab remicade |
etanercept enbrel psunrise C0168Z04 |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Infliximab TNFR-Fc fusion protein Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents |
Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |