Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00784836
• Date of registration: 29/10/2008
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
• Scientific title: A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
• Date of first enrolment: October 2008
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00784836
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: BG9418 (interferon beta 1-a)

Primary Outcome(s)

Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta) [Time Frame: assessed every 3 months up to 18 months]

Secondary Outcome(s)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Planned for up to 18 months plus 30 days; actual study duration was 111 days.]

Secondary ID(s)

108MS303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00784836