Multiple SclerosisPhase 3Avonex ChinaNCT01181115
Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)
A Phase 3 study testing Avonex in people with Multiple Sclerosis, run by Biogen at 10 sites in China.
Trial summary
The study is designed to determine the effect of weekly intramuscular (IM) administration of 30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with clinically diagnosed (using revised McDonald… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Avonex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesChina
- Study dates
- Apr 2010to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand risks of study and provide informed consent.
- Must be Chinese, aged 18 to 55 years inclusive at time of consent.
- Must have diagnosis of relapsing MS of 3 months duration at time of screening visit.
- Must have at least 1 documented MS attack within 3 years of Day 1.
- Must have EDSS score of 0 to 5 inclusive at screening visit.
- All male subjects \& female subjects of child-bearing potential must practice effective contraception during the study.
Who cannot join
- Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.
- Have had a clinical MS attack within the 50 days prior to Day 1, and or the subject has not stabilized from a previous attack in the opinion of the Investigator.
- The subject is unable to undergo a brain MRI scan for any reason.
- The subject's screening and Day 1 MRIs are both normal (negative) for lesions consistent with MS (Gd-enhancing lesions are not required, but one of the 2 MRIs should be consistent with MS).
- History of severe allergic or anaphylactic reactions.
- Known allergy to any component of the Avonex Formulation.
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- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease.
- Subjects with a history of malignant disease, including solid tumors, and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and considered cured).
- History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day 1.
- History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day 1. Note: subjects receiving ongoing antidepressant therapy will not be excluded from the study unless the medication has been increased within the 6 months prior to Day 1.
- Clinically significant abnormal ECG values as determined by the Investigator.
- Known history of human immunodeficiency virus (HIV).
- 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).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Research Site
Baotou
Research Site
Beijing
Research Site
Changchun
Research Site
Chengdu
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Nanchang
Research Site
Shanghai
Research Site
Taiyuan
Research Site
Xi'an
About this study
Official title: An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis
The study is designed to determine the effect of weekly intramuscular (IM) administration of 30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).
Read the detailed description
This is a multicenter, open-label, safety study to support registration of Avonex in China by providing data on the effect of weekly IM administration of 30mcg Avonex on safety parameters in Chinese patients with clinically diagnosed relapsing MS. This study will also include an intra-subject exploratory comparison of pre-treatment MRI (at -3 months and at month 0) and post -treatment MRI (at month 3 and month 6). Up to 60 subjects with relapsing forms of MS will be recruited to approximately 6 sites in China.
The study period will consist of screening, a 6 month open-label treatment period, and follow up at 30 days post-dosing. There will be a total of 8 clinic visits and 1 telephone contact.
Screening: will be determined 3 months +/- 7 days prior to subjects' first dose of Avonex on Day 1, at which time a screening MRI with and without Gd-enhancement will be performed.
Treatment Period: consists of eligible patients undergoing pre-dosing assessments and receiving the first dose of Avonex on day 1. Subjects will have a brain MRI within 48 hours prior to the first injection of Avonex.
Weekly doses of open-label Avonex 30mcg IM will be administered for 24 consecutive weeks for a total of 25 injections per subject. Subjects or their caregivers will be allowed to self-inject after successful completion of appropriate IM injection training.
Subjects will return to the clinic at weeks 6, 12, 18 and 24 for safety and laboratory assessments (including blood sample collection for pharmacodynamic (neopterin) and immunogenicity testing), and clinician injection site assessments. Subjects will undergo brain MRI with and without Gd enhancement at week 12 and week 24. Subjects will perform injection site pain assessments on day 1 and at weeks 6, 12, 18, and 24 recording results on a visual analog scale. Subjects who prematurely discontinue Avonex may remain in the study and continue protocol-scheduled visits/evaluations (with the exception of subject and clinician injection site assessments and neopterin sample collection.
Subjects who experience new or worsening symptoms suggestive of an MS relapse will have a neurological worsening visit within 5 days following onset of symptoms. Treatment of confirmed MS relapses will follow a protocol-specified regimen.
Post treatment period: subjects will undergo follow-up assessment at week 24 (at 24+/- 8 hours following their last Avonex injection, if applicable). Subjects will have a telephone follow up contact conducted 30 (+/- 7 days) after their last study visit to assess AEs and use of concomitant medications.
- Conditions
- Multiple Sclerosis
- Being tested
- Avonex
- Keywords
- Chinese Patients, Relapsing MS, Safety, Avonex, Tolerability, Gadolinium, Interferon Beta 1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvonexDrug
Interferon treatment for MS
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Interferon treatment for MS Receives: Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and proportion of subjects with adverse events (AEs)
Measured: 24 weeks
Assessment of clinical laboratory parameters
Measured: 24 weeks
Assessment of vital signs and physical examinations
Measured: 24 weeks
Assessment of electrocardiogram (ECG)
Measured: 24 weeks
Assessment of immunogenicity
Measured: 24 weeks
Incidence of depression
Measured: 24 weeks
Incidence of flu-like symptoms
Measured: 24 weeks
Subject assessment of injection site pain
Measured: 24 weeks
Clinical assessment of the injection site
Measured: 24 weeks
Secondary outcomes (5)
Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time
Measured: 24 weeks
Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
Measured: at month 3 and month 6
Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
Measured: at month 3 and month 6
Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment
Measured: month 6
Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181115
- Sponsor's protocol ID
- 108MS301
- Acronym
- Avonex China
- Status last verified
- Nov 2011
- First submitted
- 5 Aug 2010
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01181115
- Acronym / sponsor ID
- Avonex China / 108MS301
- Conditions
- Multiple Sclerosis
- Keywords
- Chinese Patients, Relapsing MS, Safety, Avonex, Tolerability, Gadolinium, Interferon Beta 1a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to determine the effect of weekly intramuscular (IM) administration of 30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).
Detailed description
This is a multicenter, open-label, safety study to support registration of Avonex in China by providing data on the effect of weekly IM administration of 30mcg Avonex on safety parameters in Chinese patients with clinically diagnosed relapsing MS. This study will also include an intra-subject exploratory comparison of pre-treatment MRI (at -3 months and at month 0) and post -treatment MRI (at month 3 and month 6). Up to 60 subjects with relapsing forms of MS will be recruited to approximately 6 sites in China.
The study period will consist of screening, a 6 month open-label treatment period, and follow up at 30 days post-dosing. There will be a total of 8 clinic visits and 1 telephone contact.
Screening: will be determined 3 months +/- 7 days prior to subjects' first dose of Avonex on Day 1, at which time a screening MRI with and without Gd-enhancement will be performed.
Treatment Period: consists of eligible patients undergoing pre-dosing assessments and receiving the first dose of Avonex on day 1. Subjects will have a brain MRI within 48 hours prior to the first injection of Avonex.
Weekly doses of open-label Avonex 30mcg IM will be administered for 24 consecutive weeks for a total of 25 injections per subject. Subjects or their caregivers will be allowed to self-inject after successful completion of appropriate IM injection training.
Subjects will return to the clinic at weeks 6, 12, 18 and 24 for safety and laboratory assessments (including blood sample collection for pharmacodynamic (neopterin) and immunogenicity testing), and clinician injection site assessments. Subjects will undergo brain MRI with and without Gd enhancement at week 12 and week 24. Subjects will perform injection site pain assessments on day 1 and at weeks 6, 12, 18, and 24 recording results on a visual analog scale. Subjects who prematurely discontinue Avonex may remain in the study and continue protocol-scheduled visits/evaluations (with the exception of subject and clinician injection site assessments and neopterin sample collection.
Subjects who experience new or worsening symptoms suggestive of an MS relapse will have a neurological worsening visit within 5 days following onset of symptoms. Treatment of confirmed MS relapses will follow a protocol-specified regimen.
Post treatment period: subjects will undergo follow-up assessment at week 24 (at 24+/- 8 hours following their last Avonex injection, if applicable). Subjects will have a telephone follow up contact conducted 30 (+/- 7 days) after their last study visit to assess AEs and use of concomitant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Drug: AvonexInterferon treatment for MS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to understand risks of study and provide informed consent.
- Must be Chinese, aged 18 to 55 years inclusive at time of consent.
- Must have diagnosis of relapsing MS of 3 months duration at time of screening visit.
- Must have at least 1 documented MS attack within 3 years of Day 1.
- Must have EDSS score of 0 to 5 inclusive at screening visit.
Key exclusion criteria (13 listed)
- Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.
- Have had a clinical MS attack within the 50 days prior to Day 1, and or the subject has not stabilized from a previous attack in the opinion of the Investigator.
- The subject is unable to undergo a brain MRI scan for any reason.
- The subject's screening and Day 1 MRIs are both normal (negative) for lesions consistent with MS (Gd-enhancing lesions are not required, but one of the 2 MRIs should be consistent with MS).
- History of severe allergic or anaphylactic reactions.
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 |
|---|---|---|
| AvonexInterferon treatment for MS | Drug | Active treatment |
Primary outcome
The number and proportion of subjects with adverse events (AEs)
Time frame: 24 weeks
Assessment of clinical laboratory parameters
Time frame: 24 weeks
Assessment of vital signs and physical examinations
Time frame: 24 weeks
Assessment of electrocardiogram (ECG)
Time frame: 24 weeks
Assessment of immunogenicity
Time frame: 24 weeks
Incidence of depression
Time frame: 24 weeks
Incidence of flu-like symptoms
Time frame: 24 weeks
Subject assessment of injection site pain
Time frame: 24 weeks
Clinical assessment of the injection site
Time frame: 24 weeks
5 secondary outcomes
Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time
Time frame: 24 weeks
Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
Time frame: at month 3 and month 6
Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
Time frame: at month 3 and month 6
Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment
Time frame: month 6
Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 Avonex in people with Multiple Sclerosis, run by Biogen at 10 sites in China.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number and proportion of subjects with adverse events (AEs) (time frame: 24 weeks). The study lists 9 primary outcomes in all. 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 16 Sep 2013.