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| ID | Type | Description | Link |
|---|---|---|---|
| C0168Z04 | Other Identifier | Centocor Ortho Biotech Services, L.L.C. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | infliximabOpen-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab | Biological | Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor Ortho Biotech Services, L.L.C. Clinical Trial | Centocor Ortho Biotech Services, L.L.C. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22153792 | Derived | 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. |
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A total of 217 subjects enrolled into the study but 2 subjects did not receive any study medication so they were excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab | Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) | 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). | This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1. | Posted | Number | participants | Week 10 |
|
Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infliximab | Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Research - Medical Affairs | Janssen Biotech, Inc. | 215-325-5711 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Week 10 |
| Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26 | Week 26 |
| Protocol Violation |
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| Withdrawal by Subject |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
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|
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| Secondary | Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at 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. | Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit. | Posted | Number | participants | Week 10 |
|
|
|
|
| Secondary | Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26 | This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed. | Posted | Number | participants | Week 26 |
|
|
|
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| 8 |
| 215 |
| 63 |
| 215 |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |