Recent Updates
Recently added Catalysts

Copaxone

Phase 3

Multiple Sclerosis, Relapsing-Remitting | Small molecule | Neurology |Bayer AG|Last Updated: Dec 19, 2008

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment2,244

FDA Designations

No designations recorded

Clinical trial landscape

Copaxone · 1 trial · 1 indication

Phase 3 1
NCT00099502BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) PatientsMultiple Sclerosis, Relapsing-Remitting
COMPLETED2,244 Analytics
PHASE3COMPLETED
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Multiple Sclerosis, Relapsing-RemittingUnlock trial analytics

Study Endpoints

Primary Endpoints

Hazard ratio for relapses
During the first and during the second 52 weeks

Secondary Endpoints

Time to confirmed Expanded Disability Status Score (EDSS) progression
After 52 and after 104 weeks
Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
After 104 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)DRUG250mcg administered s.c. every other day
CopaxoneDRUG20 mg administered s.c. once daily.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites199

Inclusion Criteria: * Female and male patients * Aged 18-55 years * Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0 * Treatment-naive to IFNB or Copaxone Exclusion Criteria: * Neurological progression at disease onset or between relapses * Serious or acute heart...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaDenmarkFinlandFranceGermanyGreeceHungaryIrelandIsraelItalyLatviaNetherlandsNorwayPolandRussiaSloveniaSpainSwedenSwitzerlandUkraine
Unlock Eligibility Criteria

Frequently asked questions about Copaxone

What is Copaxone used for?

Copaxone is used for the treatment of relapsing-remitting multiple sclerosis, a form of MS characterized by flare-ups followed by periods of remission. It is being developed for this neurological condition and has been studied in a Phase 3 clinical trial.

Who makes Copaxone?

Copaxone is being developed by Bayer AG, a company traded under the ticker symbol BAYRY. The drug is being studied for the treatment of relapsing-remitting multiple sclerosis and has completed a Phase 3 clinical trial.

What phase is Copaxone in?

Copaxone is in Phase 3 clinical development for relapsing-remitting multiple sclerosis. It has completed one Phase 3 trial, and it remains an investigational drug, meaning it has not yet been approved for use.

What clinical trials is Copaxone in?

Copaxone has been studied in one completed Phase 3 clinical trial, identified as NCT00099502. This trial, known as BEYOND, enrolled 2,244 participants with relapsing-remitting multiple sclerosis and was conducted across multiple countries.

Is Copaxone the same as Betaferon?

Copaxone is not the same as Betaferon. The clinical trial NCT00099502, which studied Copaxone, is titled BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis Patients, but the trial compared different treatments, and Copaxone is a distinct drug.