Patients with moderate to severe psoriasi. MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Trade Name: REMICADE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Infliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
SCHERING-PLOUGH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject must meet ALL of the criteria listed below for entry: 1. Subjects must be >=18 to =10 at Screening visit (V1) after 24 weeks of etanercept treatment. 4. Subjects who have not reached PASI 75 at Screening visit (V1) after 24 weeks of etanercept treatment or resistant ab initio to etanercept. 5. Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study. 6. Subjects are considered eligible according to the following tuberculosis (TB) screening criteria: a. Have no history of latent or active TB prior to screening; b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; d. Within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication; 8. Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB. 9. Subjects? Screening clinical laboratory tests (CBC, blood chemistry, and urine analysis) must be within the following parameters: a. Hemoglobin >=10 g/dL b. White blood cells >=3.5 x 109/L c. Neutrophils >=1.5 x 109/L d. Platelets >=100 x 109/L e. Serum creatinine <1.5 mg/dL f. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase <=1.5 x upper limit of normal g. Total bilirubin <=1.5 x upper limit of normal 9. Subjects must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that would interfere with the study evaluations. 10. Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules. 11. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must continue using such measures until 6 months after receiving the last dose of study medication. 12. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening and a negative urin
Exclusion criteria
Exclusion criteria: The subject will be excluded from entry if ANY of the criteria listed below are met: 1. Subjects who achieve PASI75 after 24 weeks of etanercept treatment. Subjects who have BSA 3 months prior to Screening). 17. Subjects who have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location. 18. Subjects who have any known malignancy or have a history of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary Objectives: To assess the efficacy of infliximab through the following parameters: PASI (Psoriasis Area and Severity Index) 50, 75,90 and 100 BSA (Body Surface Area Affected) SAPASI (Self-Administered PASI) VAS (visual analog scale) to assess itch intensity To assess the QOL (quality of life) through SKINDEX29 and DLQI. To evaluate the tolerance and safety of infliximab.;Main Objective: The primary objective of this study is to assess the efficacy of infliximab therapy (5 mg/kg by body weight), evaluated through PASI 75 (defined as the proportion of subjects achieving a >75% improvement) at week 10.;Primary end point(s): The primary efficacy endpoint for this study is the PASI 75 response rate at Week 10 (proportion of subjects achieving a ≥75% improvement in PASI from Baseline to Week 10). | — |
Countries
Italy
Outcome results
None listed