T1h in severe psoriasis-expanded access program (PUCE)

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000132
• Date of registration: 20/07/2012
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: T1h in severe psoriasis-expanded access program (PUCE)
• Scientific title: Safety and Therapeutic Effect Study of itolizumab mAb in patients with severe psoriasis.
• Date of first enrolment: 15/07/2011
• Target sample size: 80 patients
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000132-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Patricia Hernández Casaña
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Patricia Hernández Casaña
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Itolizumab (T1h) 0.4 mg /Kg body weight weekly, (intravenously) by 2 months + Itolizumab (T1h) 0.4 mg /Kg body weight every 4 weeks (intravenously) by 10 months

Primary Outcome(s)

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.

Secondary Outcome(s)

Not applicable

Secondary ID(s)

IIC RD-EC 135

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Cuban Public Health Ministry (MINSAP)

Secondary Sponsor(s)

Not applicable