Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis - Relapsing
Brief summary
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.
Interventions
DRUGBG9418 (interferon beta 1-a)
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. * Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent. * Must have a diagnosis of relapsing MS. * Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0, inclusive. * All male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of Avonex.
Exclusion criteria
* History of severe allergic or anaphylactic reactions. * Diagnosed with Primary progressive, secondary progressive, or progressive relapsing MS. * Known allergy to any component of the Avonex formulation. * History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease. * Subjects with history of malignant disease, including solid tumors and hematologic malignancies. * History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Day 1. * History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1. Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy. * Clinically significant abnormal electrocardiogram (ECG) values as determined by the investigator. * Known history of, or a positive test result for, human immunodeficiency virus (HIV). * Known history of, or a positive test result for hepatitis C virus. * Abnormal screening blood tests exceeding any of the limits defined below: 1. Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin. 2. Total white blood cell count (WBC) \<3700 cells/mm 3. Platelet count \<150,000 cells/mm 4. Hemoglobin \<10 g/dL in female subjects; \<11 g/dL in male subjects 5. Serum creatinine \>upper limit of normal (ULN) 6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) \> 1.2\*ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta) | assessed every 3 months up to 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Planned for up to 18 months plus 30 days; actual study duration was 111 days. | 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. |
Countries
United States
Participant flow
Pre-assignment details
The study expected an enrollment of 150 participants, but terminated after 3 were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Avonex Avonex 30 mcg given subcutaneously, once weekly, for 18 months. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Study Termination | 3 |
Baseline characteristics
| Characteristic | Avonex |
|---|---|
| Age, Customized <=18 years | 0 participants |
| Age, Customized > 60 years | 0 participants |
| Age, Customized Between 18 and 60 years | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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
Population: The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.
Secondary
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avonex | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| Avonex | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |