Recent Updates
Recently added Catalysts

Interferon beta-1a

Phase 3

Relapsing Multiple Sclerosis | Small molecule | Neurology |Roche Holding AG|Last Updated: Mar 8, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,656

FDA Designations

No designations recorded

Clinical trial landscape

Interferon beta-1a · 2 trials · 1 indication

Phase 3 2
NCT01412333A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisRelapsing Multiple Sclerosis
COMPLETED835 Analytics
NCT01247324A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisRelapsing Multiple Sclerosis
COMPLETED821 Analytics
PHASE3COMPLETED
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple SclerosisUnlock trial analytics
PHASE3COMPLETED
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period
Week 96

ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.

Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
Week 96

ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.

Secondary Endpoints

Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period
Week 104
Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
Baseline up to week 96
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
Baseline up to week 96
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Interferon beta-1a 44 mcg SCACTIVE_COMPARATORInterferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
OcrelizumabEXPERIMENTALOcrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.

Interventions

NameTypeDescription
Interferon beta-1aDRUG -
Ocrelizumab-matching placeboDRUG -
OcrelizumabDRUG -
Interferon beta-1a-matching placeboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites165

Inclusion Criteria: * Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010) * At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening) * Neu...

Countries:United StatesArgentinaBelarusBelgiumBosnia and HerzegovinaBrazilBulgariaCanadaCroatiaCzechiaFranceGermanyIrelandItalyMexicoNorwayPolandRussiaSlovakiaSpainSwedenTurkey (Türkiye)UkraineUnited KingdomAustraliaAustriaChileEstoniaFinlandHungaryIsraelLatviaLithuaniaNetherlandsPeruPortugalSerbiaSouth AfricaSwitzerlandTunisia
Unlock Eligibility Criteria

Frequently asked questions about Interferon beta-1a

What is Interferon beta-1a used for in Relapsing Multiple Sclerosis?

Interferon beta-1a is used for the treatment of Relapsing Multiple Sclerosis. It is an investigational drug in Phase 3 clinical development, studied as an active comparator in trials evaluating ocrelizumab. The completed trials enrolled a total of 1,656 participants across multiple countries.

Who makes Interferon beta-1a?

Interferon beta-1a is developed by Roche Holding AG, traded under the ticker RHHBY. The company is conducting Phase 3 clinical trials for this drug in Relapsing Multiple Sclerosis. Roche is the sponsor of the studies listed under the NCT numbers NCT01247324 and NCT01412333.

What phase is Interferon beta-1a in?

Interferon beta-1a is in Phase 3 clinical development for Relapsing Multiple Sclerosis. It is not FDA approved and remains investigational. The drug has been studied in two completed Phase 3 trials, both of which were randomized, double-blind, and active-controlled.

What clinical trials is Interferon beta-1a in?

Interferon beta-1a has been studied in two completed Phase 3 trials: NCT01247324 with 821 participants and NCT01412333 with 835 participants. Both trials compared ocrelizumab with Interferon beta-1a (Rebif) in participants with Relapsing Multiple Sclerosis. The trials were conducted in multiple countries including the United States, Argentina, and various European nations.

Is Interferon beta-1a the same as Rebif?

Interferon beta-1a is also known as Rebif, as indicated in the clinical trial titles. The trials compared ocrelizumab with Interferon beta-1a (Rebif) in participants with Relapsing Multiple Sclerosis. This alternative name helps identify the drug in clinical research contexts.