VERIFICARE Patients with multiple sclerosis, age between 18 and 50 MedDRA version: 6.1 Level: PT Classification code 10028245
Conditions
Interventions
Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE
Product Name: Thymoglobuline
Pharmaceutical Form: Powder and solvent
Sponsors
Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 50 Clinically and laboratory definite RRMS or RP EDSS score between 3 and 6.5 Documented rapid progression over the previous year despite conventional therapies immunomodulating and immunosuppressive treatments, see below; progression is defined as a worsening of 1 or more EDSS points between 3 and 6 or 0.5 or more between 6 and 6.5 or at least three relapses in the previous year also without progression of the disease despite conventional therapies immunomodulating and immunosuppressive treatments, see below Presence of at least 1 enhancing area on brain MRI using a triple dose TD of Gd Previous treatment with immunomodulating drugs interferon beta or glatiramer acetate without efficacy Previous treatment with immunosuppressive drugs Mitoxantrone or CY at standard dosage without efficacy Acceptance of using a valid birth control Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary progressive or Secondary Progressive MS Relapse in the last 30 days Previous treatment with TBI or TLI Treatment with Interferons, Cop1 or steroids in the last month Treatment with CY, Mitoxantrone, Aza, or other immunosuppressant in the last 3 months Concomitant diseases of lungs, kidneys, liver, heart, endocrine or neurological systems, Infectious illnesses, Psychiatric disturbances Left ventricular ejection fraction 50 , unexplained ECG abnormalities History of recurrent urinary tract infections or respiratory infections Pregnancy, breast feedings, patient s non compliance to use birth control methods Contraindications for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is therefore the search of a new light immunoablative regimen, with a better safety profile than BEAM but with a similar efficacy.;Secondary Objective: Obtain information on the clinical course progression, evaluated with EDSS and MSFC or number or relapses in the 24 months following ASCT. Collect other MRI data, such as brain atrophy, total lesion load, new T2 lesions, diffusion tensor imaging, after 1 and 2 years from ASCT. Study of the immunological recovery and regeneration of the immune repertoire after ASCT Effect of the treatment on fertility Quality of life outcome evaluation;Primary end point(s): The primary endpoint of the study is to evaluate the safety and the effect on Gd-enhanced MRI of ASCT using a new conditioning regimen CY 120 mg/Kg followed by ATG in a population of severe MS cases, with clinical and MRI signs of disease activity, unresponsive to conventional immunomodulating and immunosuppressive therapy. | — |
Countries
Italy
Outcome results
None listed