A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 21 August 2023
• Main ID: EUCTR2008-003098-42-CZ
• Date of registration: 27/10/2008
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Ltd
• Public title: A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
• 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: 06/01/2009
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003098-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria within 28 days prior to their first dose of Avonex® on Day 1 (Baseline Visit):

1. 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.
2. Male or female aged 18 to 60 years old, inclusive, at the time of informed consent.
3. Must have a diagnosis of relapsing MS, as defined by the revised McDonald Committee criteria.
4. Must have a screening EDSS score between 0 and 6.0, inclusive.
5. All male subjects and female subjects 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®.
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:
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment on Day 1 (Baseline Visit):

Medical History
1. Primary progressive, secondary progressive, or progressive relapsing MS. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
2. History of severe allergic or anaphylactic reactions.
3. Known allergy to any component of the Avonex® formulation.
4. 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.
5. Subjects with a history of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
6. History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Day 1.
7. 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. NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the study unless the dose has been increased within the 3 months prior to Day 1.
8. Clinically significant abnormal ECG values as determined by the Investigator.
9. Known history of, or a positive test result for, human immunodeficiency virus (HIV).
10. Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).
11. Abnormal screening blood tests exceeding any of the limits defined below:
• Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal (>2xULN) or aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) >2xULN or bilirubin >1.5xULN
• Total white blood cell count (WBC) <3700 cells/mm3
• Platelet count <150,000 cells/mm3
• Hemoglobin <10g/dL in female subjects; <11g/dL in male subjects
• Serum creatinine >ULN
• Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.2 xULN

Treatment History
12. Any previous treatment with any interferon product.
13. History of hypersensitivity or intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, or aspirin that would preclude use of at least one of these during the study.
14. Treatment with other agents to treat MS symptoms or underlying disease 15. Prior treatment with any other investigational drug for MS, or any other condition, not listed above, unless approved by the Biogen Idec Medical Director.

Miscellaneous
16. Female subjects who are currently pregnant or breast feeding. Female subjects of child bearing potential who have a positive pregnancy test at either the Screening Visit or the Day 1 (Baseline) Visit may not be enrolled into

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

To evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis

Intervention(s)

Trade Name: AVONEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: interferon beta 1a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-

Primary Outcome(s)

Primary end point(s): The primary objective of the study is to evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS. The number and percentage of subjects who develop NAbs to IFN-beta is the primary endpoint in the evaluation of immunogenicity.

Secondary Objective: To evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.

The endpoints to assess safety are as follows:

•The number and proportion of subjects with adverse events (AEs)
•Assessment of clinical laboratory parameters
•Assessment of vital signs and physical examinations
The tolerability endpoint is the clinician assessment of the injection site for erythema, induration, tenderness to digital pressure, and local temperature.

Main Objective: To evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS. The number and percentage of subjects who develop neutralizing antibodies (NAbs) to interferon-beta (IFN-beta) is the primary endpoint in the evaluation of immunogenicity.

Secondary ID(s)

108MS303

Ethics review

Status: Approved
Approval date: 13/10/2008
Contact:

Results

• Results available: Yes
• Date Posted: 26/03/2015
• Date Completed: 17/02/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-003098-42/results