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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001243-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Essex Pharma GmbH | INDUSTRY |
| Centocor, Inc. | INDUSTRY |
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This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I ("high need") or GROUP II ("low-need") by the investigator according to their previous psoriasis treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (high-need) | Experimental | Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). |
|
| Group II (low-need) | Experimental | Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score | PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease). | Baseline and Week 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (High-need) | Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14. |
| FG001 | Group II (Low-need) | Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (High-need) | Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14. |
| 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, Customized | Number |
| 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 | Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score | PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease). | Per Protocol Population - All participants in the intent to treat population who completed the study without major protocol violations. For missing data, the last observation carried forward (LOCF) was applied. | Posted | Number | Proportion of participants | Baseline and Week 22 |
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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 | Group 1 (High-need) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 9.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| 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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|
| Lost to Follow-up |
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| Adverse Event |
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| Withdrawal by Subject |
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| Inclusion/exclusion criteria violation |
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| Protocol deviation |
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| Diagnosis of Tuberculosis |
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| Malignancy |
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| Opportunistic infection |
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| Abnormal liver function tests |
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| BG001 | Group II (Low-need) | Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Group II (Low-need) | Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14. |
|
|
| 26 |
| 297 |
| 62 |
| 297 |
| EG001 | Group 2 (Low-need) | 18 | 296 | 42 | 296 |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| CARDIOVASCULAR DISORDER | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| SUDDEN HEARING LOSS | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| BLINDNESS UNILATERAL | Eye disorders | MedDRA 9.1 | Systematic Assessment |
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| RETINAL DETACHMENT | Eye disorders | MedDRA 9.1 | Systematic Assessment |
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| VITREOUS DISORDER | Eye disorders | MedDRA 9.1 | Systematic Assessment |
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| DUODENITIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| OESOPHAGEAL ULCER | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 9.1 | Systematic Assessment |
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| INFUSION RELATED REACTION | General disorders | MedDRA 9.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 9.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| SUDDEN CARDIAC DEATH | General disorders | MedDRA 9.1 | Systematic Assessment |
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| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
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| SERUM SICKNESS | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| TUBERCULOSIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| STERNAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| WHIPLASH INJURY | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 9.1 | Systematic Assessment |
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| TRANSAMINASES INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| LYMPHANGIOSIS CARCINOMATOSA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| METASTATIC RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| OVARIAN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| URINARY RETENTION | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
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| EPIDIDYMITIS | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| BURSA REMOVAL | Surgical and medical procedures | MedDRA 9.1 | Systematic Assessment |
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| URETHRAL OPERATION | Surgical and medical procedures | MedDRA 9.1 | Systematic Assessment |
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| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| SHOCK | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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The investigator agrees not to pubish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any elecontronic media) that report any results of study.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |