Moderate to severe plaque-type psoriaris (psoriasis vulgaris). MedDRA version: 7.1 Level: LLT Classification code 10037153
Conditions
Interventions
Trade Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: infliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
essex pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient Inclusion Criteria The patient must meet the ALL criteria listed below for entry: Patient Inclusion Criteria at Screening Visit (Visit 0) 1. Written informed consent by the patient for study participation, prior to protocol specific procedures. 2. Patients who are 18 years of age or older at time of enrolment, may be male or female and of any race. 3. Diagnosis of plaque-type psoriasis (psoriasis vulgaris) at least 6 months prior to screening. 4. Plaque-type psoriasis covering at least 10% of total body surface area. 5. PASI-Score of 12 or greater. 6. GROUP I (“high need”) patients: Adult patients with moderate to severe plaque psoriasis who are either not controlled by, or are intolerant to or have contraindications to at least two currently available systemic therapies (e.g. photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). GROUP II (“low need”) patients: Adult patients with moderate to severe plaque psoriasis who have undergone pre-treatment with no more than one currently available systemic therapy (e.g. photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). 7. Patients must have had a chest x-ray (preferably posteroanterior and lateral) within 3 months prior to first infusion with no evidence of malignancy, infection (e.g. tuberculosis) or fibrosis. 8. Laboratory test results: liver enzymes (AST, ALT, GGT and alkaline phosphatase) must be within 1.5 times the upper limit of normal range (ULN), total bilirubin = 1.0 ULN, serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient Exclusion Criteria The patient will be excluded from entry if ANY of the criteria listed below are met: Patient Exclusion Criteria at Screening Visit (Visit 0) Prior and Concomitant Diseases 1. Patients suffering from active or latent tuberculosis. Prior to the start of treatment with infliximab tuberculosis needs to be excluded following the recommendations published by the German Paul Ehrlich Institut. 2. Patients who have had or have a serious infection (e.g. abscess, pneumonia or pyelonephritis) or who have been hospitalized or received treatment with i.v. antibiotics during the previous 2 months. 3. Patients who are known to be infected with human immunodeficiency virus, hepatitis B or C virus, prior or current opportunistic infections (within the last six months, H. zoster within the last 2 months). 4. Patients suffering from congestive heart failure including medically controlled asymptomatic patients. 5. History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis. 6. Patients who have current signs and symptoms or history of systemic lupus erythematosus. 7. Patients suffering from non-plaque psoriasis, e.g. erythrodermic, guttate or pustular forms. The presence of psoriasis-arthritis is no exclusion criterion. 8. Patients suffering from current drug induced psoriasis (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers or calcium-channel-blockers). If the patient takes one of those substances on aregular basis, it should be on a stable dose for at least three weeks prior to baseline. 9. Patients suffering from severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric diseases, that, in the opinion of the investigator, would interfere with the study evaluations or safe or optimal participation in the study. 10. Any known malignancy during the last five years (except basal cell carcinoma), any history of lymphoproliferative disease. Prior Medication 11. Patients who have received any systemic psoriasis therapy (e.g. immunosuppressant) or lithium within 28 days of baseline visit. 12. Patients pretreated with etanercept or efalizumab within 28 days of Baseline. 13. Patients previously treated with infliximab. 14. Patients who have used topical treatments that could affect PASI evaluation (e.g. corticosteroids, anthralin, topical vitamin D derivates) within 2 weeks of baseline visit, except special areas like head or hands. 15. Patients who have used any investigational drug within 3 months of Baseline. Others 16. Patients with allergy/sensitivity to study drug or its excipients. 17. Women who are breast-feeding, pregnant, or intend to become pregnant. 18. Patients with any clinically significant condition or situation, other than the condition being studied. 19. Patients who are participating in any other clinical study. 20. Patients who are part of the staff personnel directly involved with this study. 21. Patients who are a family member of the investigational study staff. Patient Exclusion Criteria at Baseline Visit (Visit 1) 1. Patients who have used any investigational drug within 3 months before baseline. 2. Patients who have received any systemic psoriasis therapy (e.g. immunosuppressant) or lithium within 28 days of baseline visit. 3. Patients pretreated with etanercept or efalizumab within 28 days of Baseline. 4. Patients who have used topical trea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint of the study is defined as the proportion of patients achieving a = 75% improvement in PASI score from baseline to week 22 as compared between GROUP I and GROUP II patients.;Main Objective: The objective of this study is to demonstrate equivalence of infliximab for GROUP I ("high-need") patients compared to GROUP II ("low-need") patients. This will be done by comparing the efficacy and safety in both groups. A non-inferiority approach will be applied. Primary objective Proportion of patients achieving a = 75% improvement in PASI score from baseline to week 22 as compared between GROUP I and GROUP II patients.;Secondary Objective: Proportion of patients achieving a Physician Global Assessment (PGA) score of cleared (1) or excellent (2) at week 2, 6, 14 and 22. Proportion of patients achieving a = 90% improvement in PASI score from baseline to week 2, 6, 14 and 22. Change in patient´s and physician´s global assessment of nail involvement from baseline to week 22. Change in patient´s assessment of pruritus from baseline to week 2, 6, 14 and 22. Change in Dermatology Life Quality Index from baseline to week 6, 14 and 22. Change in SF-36 from baseline to week 6, 14 and 22. Overall treatment satisfaction assessed by patient at week 22. Proportion of patients with organ toxicity (refers to liver and kidney). Proportion of patients with adverse events. Incidence and intensity of adverse events. Overall tolerability assessed by patient at week 22. | — |
Countries
Germany
Outcome results
None listed