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Label indication AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AVONEX is for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ) FDA label
Also known as (IM) AVONEX®, Interferon beta 1a, Interferon beta-1a (Avonex), BG9418 (interferon beta-1a), BG9418, Avonex Pen, Interferon beta type 1a, IFN β-1a
Avonex · 3 trials · 2 indications
A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
| Arm | Type | Description |
|---|---|---|
| Active treatment | EXPERIMENTAL | Interferon treatment for MS |
| Avonex Single-Use Autoinjector | EXPERIMENTAL | Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. |
| Interferon beta-1a | EXPERIMENTAL | Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo IM injection twice weekly for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Avonex | DRUG | Interferon treatment for MS |
| single-use autoinjector with a prefilled liquid Avonex syringe | DEVICE | - |
| Avonex prefilled syringe via manual IM injection | DEVICE | - |
| BG9418 (interferon beta-1a) | DRUG | - |
| Placebo | DRUG | Placebo IM injection, self-administered per protocol. |
Inclusion Criteria: * 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 y...
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Avonex is used for the treatment of multiple sclerosis, a neurological condition. It is studied in patients with relapsing forms of MS, including a Phase 3 safety and tolerability trial in Chinese subjects with relapsing multiple sclerosis. The drug is developed by Biogen Inc. and is given in the multiple sclerosis therapeutic area.
Avonex is made by Biogen Inc., which trades under the ticker BIIB. Biogen is the developer of the drug, and it is studied in multiple sclerosis. The company conducted a Phase 3 trial of Avonex in Chinese subjects with relapsing multiple sclerosis.
Avonex is in Phase 3 development for multiple sclerosis. One Phase 3 trial has been completed, and no active trials are currently listed. The completed trial, NCT01181115, enrolled 60 participants and evaluated safety and tolerability in Chinese subjects with relapsing multiple sclerosis.
Avonex has been studied in a Phase 3 trial, NCT01181115, titled Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis. The trial was completed, enrolled 60 participants, and was conducted in China. It was an uncontrolled study without randomization or double blinding.
Yes, Avonex is also known as (IM) AVONEX®. Both names refer to the same product developed by Biogen Inc. for multiple sclerosis. The parenthetical IM likely denotes intramuscular administration, but no further details on the route are provided in the available trial information.