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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00099502




Registration number
NCT00099502
Ethics application status
Date submitted
15/12/2004
Date registered
16/12/2004
Date last updated
19/12/2008

Titles & IDs
Public title
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Scientific title
International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.
Secondary ID [1] 0 0
EudraCT: 2005-002235-27
Secondary ID [2] 0 0
91162
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Treatment: Drugs - Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Treatment: Drugs - Copaxone

Experimental: Arm 1 -

Experimental: Arm 2 -

Active Comparator: Arm 3 -


Treatment: Drugs: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day

Treatment: Drugs: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day

Treatment: Drugs: Copaxone
20 mg administered s.c. once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hazard ratio for relapses
Timepoint [1] 0 0
During the first and during the second 52 weeks
Secondary outcome [1] 0 0
Time to confirmed Expanded Disability Status Score (EDSS) progression
Timepoint [1] 0 0
After 52 and after 104 weeks
Secondary outcome [2] 0 0
Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
Timepoint [2] 0 0
After 104 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Neurological progression at disease onset or between relapses

- Serious or acute heart diseases

- History of severe depression or suicide attempt

- Serious or acute liver, renal or bone marrow dysfunction

- Monoclonal gammopathy

- Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to
human albumin or to mannitol

- Pregnancy or lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
2244
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Gosford
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine

- whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe,
tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms

- whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more
efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg
Trial website
https://clinicaltrials.gov/ct2/show/NCT00099502
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00099502