Multiple SclerosisPhase 3NCT00784836
Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
A Phase 3 study testing BG9418 (interferon beta 1-a) in people with Multiple Sclerosis, run by Biogen at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BG9418 (interferon beta 1-a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- 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.
- Total white blood cell count (WBC) <3700 cells/mm
- Platelet count <150,000 cells/mm
- Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects
- Serum creatinine >upper limit of normal (ULN)
- Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MS Center at Texas Neurology
Dallas, Texas, 75214
Henry Ford Hospital
Detroit, Michigan, 48202
About this study
Official title: A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- BG9418 (interferon beta 1-a)
- Keywords
- Multiple Sclerosis - Relapsing
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG9418 (interferon beta 1-a)Drug
Also called Avonex
| Study group | Role | What they receive |
|---|---|---|
| Avonex | Experimental | Avonex 30 mcg given subcutaneously, once weekly, for 18 months. Receives: Drug: BG9418 (interferon beta 1-a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed every 3 months up to 18 months
Secondary outcomes (1)
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.
Measured: Planned for up to 18 months plus 30 days; actual study duration was 111 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Terminated early by Sponsor for business reasons unrelated to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784836
- Sponsor's protocol ID
- 108MS303
- Status last verified
- Apr 2014
- First submitted
- 29 Oct 2008
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00784836
- Acronym / sponsor ID
- 108MS303
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis - Relapsing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early by Sponsor for business reasons unrelated to safety.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avonex | Experimental | Drug: BG9418 (interferon beta 1-a)Avonex 30 mcg given subcutaneously, once weekly, for 18 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG9418 (interferon beta 1-a)Also: Avonex | Drug | Avonex |
Primary outcome
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
Time frame: 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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BG9418 (interferon beta 1-a) in people with Multiple Sclerosis, run by Biogen at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta) (time frame: assessed every 3 months up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.