multiple sclerosis MedDRA version: 9.1 Level: SOC Classification code 10029205 MedDRA version: 9.1 Level: HLGT Classification code 10012303 MedDRA version: 9.1 Level: HLT Classification code 10052785 MedDRA version: 9.1 Level: LLT Classification code 10063399
Conditions
Interventions
Trade Name: AVONEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Sponsors
BIOGEN-DOMPE` SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. They need to have a diagnosis of relapsing remitting MS according to Mc Donald revised criteria 2. They will be naive for any DMTs therapy and will undergo therapy with IFN- 1a due to their clinical features as required by nota 65 AIFA 3. They will be more than 18 years old 4. They will have and EDSS between 0 and 4.5. 5. No steroids for at least 1 month before starting IFN-1a therapy 6. All subjects must give informed consent 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: 1. Primary progressive, secondary progressive, or progressive relapsing multiple sclerosis 2. Concurrent DMTs 3. Steroids during the month before starting IFN- 1a therapy 4. Concomitant or in the previous year immunosuppressive therapies 5. History of alcohol or drug abuse within 2 years prior to randomization. 6. No resolution of a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomization 7. History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of an IFN-β for the duration of the study 8. Presence of infectious or flu like symptoms in the week before the beginning of the study 9. Nursing mothers, pregnant women, and women planning to become pregnant while on study 10. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject`s ability to comply with the study protocol according to the Investigator and/or the Sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define whether individual`s IL-6 and TNF-alpha polymorphisms, at the position -174 and -376 of the IL-6 and TNF-alpha genes, respectively may be relevant for the development of Flu Like Syndrome (FLS) in Multiple Sclerosis (MS) patients treated with Interferon Beta (IFN-)1 a im;Secondary Objective: 1. to verify if different IL-6 and TNF- polymorphisms are associate with mild or severe symptoms and with short or prolonged FLS 2. to investigate whether IL-6 polymorphism is associated with different levels of IL-6 in the serum of naive MS patients 3. to study if IL-6 polymorphism is associated with different levels of IL-6 in the serum of IFN- treated MS patients and if this is associated with more or less severe FLS symptoms.;Primary end point(s): A diary for the evaluation of the severity of FLS will fill out by patient after every injection for the first 12 weeks while on IFN-β 1 a im treatment and at 12 month. | — |
Countries
Italy
Outcome results
None listed