The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Henry Ford Hospital
Detroit, Michigan, United States
MS Center at Texas Neurology
Dallas, Texas, United States
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.
Time frame: assessed every 3 months up to 18 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time frame: Planned for up to 18 months plus 30 days; actual study duration was 111 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.