Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01939002 | Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017) | PHASE3 | COMPLETED | 251 | — | — | Nov 1, 2013 | Nov 1, 2015 | Jan 25, 2017 | 38 | United States |
| NCT00906399 | Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis | PHASE3 | COMPLETED | 1,516 | — | — | Jun 1, 2009 | Oct 1, 2013 | Sep 19, 2014 | 178 | United States, Belgium +24 |
The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (\< 4 versus ≥ 4), baseline age (\< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
| Arm | Type | Description |
|---|---|---|
| BIIB017 plus current FLS therapy | EXPERIMENTAL | Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician. |
| BIIB017 plus naproxen | EXPERIMENTAL | Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently. |
| Placebo | PLACEBO_COMPARATOR | Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks. |
| Peginterferon Beta-1a Q2W | EXPERIMENTAL | 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks. |
| Peginterferon Beta-1a Q4W | EXPERIMENTAL | 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm). |
| Name | Type | Description |
|---|---|---|
| BIIB017 | DRUG | - |
| naproxen | DRUG | - |
| BIIB017 (peginterferon beta-1a) | DRUG | Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection. |
| Placebo | DRUG | Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection. |
Key Inclusion Criteria: * Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 \[Polman 2005\] * Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0 * Must be treated with IFN-β ...