Psoriasis
Conditions
Interventions
group 1: itolizumab (T1h) 0.4 mg /Kg body weight weekly, (intravenously) by 2 months and then itolizumab (T1h) 0.4 mg /Kg body weight o 1.6 mg/Kg every 4 weeks (intravenously) by 10 months
group 2: it
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years (Both inclusive), of any gender or skin color 2. Patients with clinical and histopatological diagnozed of active severe psoriasis 3. Patients must have been treated unsuccessfully with, or who are intolerant to or have a contraindication to receiving anti-psoriatic treatments currently available in the country. 4. Baseline PASI =10 5. Patients receiving immunosupressive therapy (including retinoids) for Psoriasis can be included after a washout period of 4 weeks. Oral Glucocorticoids =10 mg/day permitted if stable prior to baseline for Psoriatic arthritis patients. 6. Patients comply with the requirements of the clinical laboratory: •Hemoglobin, men =12.0 g/dL, women =11.0 g/dL, WBC> 3x109 cells / mL, ALC >1.3x109 cel/ml, platelet count > 150x109/mL, ANC= 1,5x109 /L •Creatinine within the normal reference values (UI). •Transaminase (TGP), bilirrubin and alcaline fosfatase (AF) within the normal reference values (UI). 7. Able and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Uncompensated suffering from chronic diseases (heart diseases, diabetes mellitus, hypertension, chronic renal failure, bronchial asthma) 2. History of or Suffering from any malignancy (including solid tumours, hematologic malignancies and carcinoma in situ) 3. History of Chronic or current infectious disease (at screening patients with chest radiograph and laboratory test) 4. Pregnancy, childbirth and / or breastfeeding. 5. Patients who refuse to use contraception during the study. 6. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AE). Measuring time: weeks 5, 9, 12 and every 4 weeks until 12 months. - Presence of AE (Yes/No). -Description of AE. Name of the event -Duration of AE. (Difference between the beginning date and the finish date of the event) -Intensity of AE (Slight, Moderate, Severe) -Severity of AE (Severe/Serious, Not severe/Not serious) - Attitude to study treatment (Unchanged, Dose modification, Temporary discontinuation of study treatment, Permanent discontinuation of study treatment) -Outcome of AE (Recovered, Improved, Persist, Sequelae, Death) -Relationship causality (Definitive, Very likely, Probable, Possible, Not related, Unknown) Clinical Response (PASI: PASI= 90-Response, 50=PASI <90- No response, PASI<50-Worse). Measurement time: weeks 5, 9, 12 and every 4 weeks until 12 months. | — |
Countries
Cuba
Contacts
Public ContactPatricia Hernández Casaña
Center of Molecular Immunology (CIM)
Outcome results
None listed