Relapsing Remitting Multiple Sclerosis
Conditions
Interventions
Arm 1 Study group (Itolizumab): Itolizumab 1.6 mg/Kg body weight bewekly, (intravenously) by 12 weeks, Itolizumab 1.6 body weight every 4 weeks (intravenously) by 40 weeks. Interferon
Arm 2 Study grou
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Able and willing to give written informed consent. 2. Diagnosis of RRMS, as defined by revised Mc Donald Criteria. 3. MS for at least 1 year. 4. Currently on treatment with interferon beta-1b (IFNß) within 12 month before randomization. 5. Active RRMS, defined by: = 1 clinical relapse, at 12 previous months on treatment with IFNß. = 1 gadolinium-enhancing lesión by magnetic resonance imaging (MRI) scans, at baseline. = 1 new T2-hyperintense lesions or FLAIR, compared with previous MRI scans 6. Clinical stability within 30 days before randomization (without steroids). 7. Expanded Disability Status Scale (EDSS) 0 - 5, at baseline. 8. Normal laboratory values at screening: –Hemoglobin-men = 12.0 g/dl, women = 11.0 g/dl; Leucocytes > 5x109 L, Platelets count >150x109/L, Neutrophils > 1.8 x 109/L, Lymphocytes > 1.2x109 cel/mL, . –kidney function: creatinine < < 113 µmol/L. -Liver function: TGP < 49 U/l y TGO < 46 U/l); ?-glutamiltransferasa (GGT), men = 65 U/l, women = 45 U/l) 9. Male or female, aged 18-55 years (both inclusive), no preference will be made based on skin color.
Exclusion criteria
Exclusion criteria: 1. Has diagnosis of primary or secondary progressive or progressive relapsing MS 2. Current use of systemic steroids or immunosuppressive medications within 1 month before randomization 3. Evidence of significant uncontrolled concomitant disease which in the investigator's opinion would preclude patient participation 4. History of malignancy. 5. History of sistemic chronic or acute infection which in the investigator's opinion would preclude patient participation 6. Patients who have been previously treated with monoclonal antibody. 7. History of allergy to chemical or biologicl compounds similar to the experimental product. 8. Pregnancy, childbirth and / or breastfeeding. 9. Patients who refuse to use contraception during the study. 10. 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 |
|---|---|
| Safety outcomes: Incidence of Adverse Events (AE) (type (name of AE), Intensity (Mild, Moderate, Severe), Gravity (Serious, Not serious), causality relationship (Very Likely, Likely, Possible, Not related, Unknown). Measuring time: 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcomes: -Number of clínical relapse. Measuring time: 52 weeks. -Time to relapse (Time in months from baseline until it objectively documented clinical relapse. Measuring time: 52 weeks. -Number of new gadolinium-enhancing lesions. Number of cumulative gadolinium-enhancing lesions. Measuring time: at baseline, 24 and 52 weeks. -Number of new or enlarging T2-hyperintense lesions. Measuring time: at baseline, 24 and 52 weeks. -Sustained disability progression (Change From Baseline in Expanded Disability Status Score (EDSS). Measuring time: at baseline, 12, 24, 39 and 52 weeks. -Time to sustained disability progression (Time in months from baseline until it objectively documented sustained disability progression). Measuring time: 52 weeks. -Proportion of patients free of relapse. Measuring time: at 24 and 52 wweks. -Proportion of patients free of desease. Measuring time: at 24 and 52 weeks. Biodistribution outcomes: -Internal dosimetry Calculation (From the scintigraphic imaging of the central nervous system acquired through methodology MIRD using the software MIRDOSE3). Measuring time: 4 and 24 hours post administration of 99mTc-itolizumab. -Percentage of the administered dose (% ID = Total counts in the organ by 100% / Total counts corresponding to the administered dose) Measurement time: 4 and 24 hours post administration of 99mTc-itolizumab. -Degree of agreement (Agreement between the accumulation of 99mTc-itolizumab and location of lesions in the central nervous system diagnosed by MRI and by scintigraphic studies Gamma Camera). Measuring time: 2h, 4h, 8h and after administration of 24h 99m itolizumab. Immune response outcomes: -Percent subpopulations in peripheral blood lymphoid cells. Measuring Time: Weeks 12, 24, 39 and 52. -Percentage of cytokine expression pattern. Measuring Time: Weeks 12, 24, 39 and 52. -Percentage of lymphocyte activation. Measuring Time: Weeks 12, 24, 39 and 52. | — |
Countries
Cuba
Contacts
Public ContactPatricia Hernandez-Casaña
Center of Molecular Immunology (CIM)
Outcome results
None listed