Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Capital Federal
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Argentina
State/province [36] 0 0
Buenos Aires
Country [37] 0 0
Argentina
State/province [37] 0 0
Cordoba
Country [38] 0 0
Austria
State/province [38] 0 0
Niederösterreich
Country [39] 0 0
Austria
State/province [39] 0 0
Steiermark
Country [40] 0 0
Austria
State/province [40] 0 0
Tirol
Country [41] 0 0
Austria
State/province [41] 0 0
Linz
Country [42] 0 0
Belgium
State/province [42] 0 0
Bruxelles - Brussel
Country [43] 0 0
Belgium
State/province [43] 0 0
Leuven
Country [44] 0 0
Belgium
State/province [44] 0 0
Melsbroek
Country [45] 0 0
Brazil
State/province [45] 0 0
Parana
Country [46] 0 0
Brazil
State/province [46] 0 0
PE
Country [47] 0 0
Brazil
State/province [47] 0 0
RJ
Country [48] 0 0
Brazil
State/province [48] 0 0
RS
Country [49] 0 0
Brazil
State/province [49] 0 0
Sao Paulo
Country [50] 0 0
Brazil
State/province [50] 0 0
SP
Country [51] 0 0
Canada
State/province [51] 0 0
Alberta
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Manitoba
Country [54] 0 0
Canada
State/province [54] 0 0
Nova Scotia
Country [55] 0 0
Canada
State/province [55] 0 0
Ontario
Country [56] 0 0
Canada
State/province [56] 0 0
Quebec
Country [57] 0 0
Denmark
State/province [57] 0 0
Aarhus C
Country [58] 0 0
Finland
State/province [58] 0 0
Oulu
Country [59] 0 0
Finland
State/province [59] 0 0
Tampere
Country [60] 0 0
France
State/province [60] 0 0
Bretagne
Country [61] 0 0
France
State/province [61] 0 0
Gironde
Country [62] 0 0
France
State/province [62] 0 0
Caen
Country [63] 0 0
France
State/province [63] 0 0
Clermont ferrand
Country [64] 0 0
France
State/province [64] 0 0
Dijon
Country [65] 0 0
France
State/province [65] 0 0
Lille
Country [66] 0 0
France
State/province [66] 0 0
Lyon
Country [67] 0 0
France
State/province [67] 0 0
Nancy
Country [68] 0 0
France
State/province [68] 0 0
Nantes
Country [69] 0 0
France
State/province [69] 0 0
Nice
Country [70] 0 0
France
State/province [70] 0 0
Nimes
Country [71] 0 0
France
State/province [71] 0 0
Toulouse
Country [72] 0 0
Germany
State/province [72] 0 0
Baden-Württemberg
Country [73] 0 0
Germany
State/province [73] 0 0
Bayern
Country [74] 0 0
Germany
State/province [74] 0 0
Brandenburg
Country [75] 0 0
Germany
State/province [75] 0 0
Hessen
Country [76] 0 0
Germany
State/province [76] 0 0
Mecklenburg-Vorpommern
Country [77] 0 0
Germany
State/province [77] 0 0
Niedersachsen
Country [78] 0 0
Germany
State/province [78] 0 0
Nordrhein-Westfalen
Country [79] 0 0
Germany
State/province [79] 0 0
Rheinland-Pfalz
Country [80] 0 0
Germany
State/province [80] 0 0
Sachsen-Anhalt
Country [81] 0 0
Germany
State/province [81] 0 0
Sachsen
Country [82] 0 0
Germany
State/province [82] 0 0
Berlin
Country [83] 0 0
Germany
State/province [83] 0 0
Hamburg
Country [84] 0 0
Greece
State/province [84] 0 0
Attica
Country [85] 0 0
Greece
State/province [85] 0 0
Athens
Country [86] 0 0
Greece
State/province [86] 0 0
Thessaloniki
Country [87] 0 0
Hungary
State/province [87] 0 0
Budapest
Country [88] 0 0
Hungary
State/province [88] 0 0
Györ
Country [89] 0 0
Hungary
State/province [89] 0 0
Miskolc
Country [90] 0 0
Hungary
State/province [90] 0 0
Pecs
Country [91] 0 0
Hungary
State/province [91] 0 0
Zalaegerszeg
Country [92] 0 0
Ireland
State/province [92] 0 0
Dublin 24
Country [93] 0 0
Ireland
State/province [93] 0 0
Cork
Country [94] 0 0
Ireland
State/province [94] 0 0
Dublin
Country [95] 0 0
Israel
State/province [95] 0 0
Ashkelon
Country [96] 0 0
Israel
State/province [96] 0 0
Haifa
Country [97] 0 0
Israel
State/province [97] 0 0
Jerusalem
Country [98] 0 0
Israel
State/province [98] 0 0
Petach Tikva
Country [99] 0 0
Israel
State/province [99] 0 0
Tel Hashomer
Country [100] 0 0
Israel
State/province [100] 0 0
Tel-Aviv
Country [101] 0 0
Israel
State/province [101] 0 0
Zerifin
Country [102] 0 0
Italy
State/province [102] 0 0
BA
Country [103] 0 0
Italy
State/province [103] 0 0
FI
Country [104] 0 0
Italy
State/province [104] 0 0
MI
Country [105] 0 0
Italy
State/province [105] 0 0
PD
Country [106] 0 0
Italy
State/province [106] 0 0
RO
Country [107] 0 0
Italy
State/province [107] 0 0
TO
Country [108] 0 0
Latvia
State/province [108] 0 0
Riga
Country [109] 0 0
Netherlands
State/province [109] 0 0
Gelderland
Country [110] 0 0
Netherlands
State/province [110] 0 0
Breda
Country [111] 0 0
Netherlands
State/province [111] 0 0
Sittard
Country [112] 0 0
Norway
State/province [112] 0 0
Bergen
Country [113] 0 0
Poland
State/province [113] 0 0
Gdansk
Country [114] 0 0
Poland
State/province [114] 0 0
Katowice
Country [115] 0 0
Poland
State/province [115] 0 0
Lodz
Country [116] 0 0
Poland
State/province [116] 0 0
Poznan
Country [117] 0 0
Poland
State/province [117] 0 0
Warszawa
Country [118] 0 0
Poland
State/province [118] 0 0
Wroclaw
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Moscow
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Moskva
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Nizhny Novogorod
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Novosibirsk
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Sankt-Peterburg
Country [124] 0 0
Russian Federation
State/province [124] 0 0
St. Petersburg
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Yaroslavl
Country [126] 0 0
Slovenia
State/province [126] 0 0
Ljubljana
Country [127] 0 0
Slovenia
State/province [127] 0 0
Maribor
Country [128] 0 0
Spain
State/province [128] 0 0
Barcelona
Country [129] 0 0
Spain
State/province [129] 0 0
Málaga
Country [130] 0 0
Spain
State/province [130] 0 0
Sevilla
Country [131] 0 0
Sweden
State/province [131] 0 0
Helsingborg
Country [132] 0 0
Sweden
State/province [132] 0 0
Stockholm
Country [133] 0 0
Sweden
State/province [133] 0 0
Uppsala
Country [134] 0 0
Switzerland
State/province [134] 0 0
Bern
Country [135] 0 0
Switzerland
State/province [135] 0 0
St. Gallen
Country [136] 0 0
Ukraine
State/province [136] 0 0
Donetsk
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kharkiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Kiev
Country [139] 0 0
Ukraine
State/province [139] 0 0
Lviv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00099502