Relationship between IL-6 and TNF-α polymorphism and flu-like syn
Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
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.
Who could take part
Relapsing MS · EDSS 0 to 4.5
Show the full criteria
Inclusion criteria
Inclusion: 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 Exclusion: 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Apr 2010