Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Show all queries
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00459667
Registration number
NCT00459667
Ethics application status
Date submitted
11/04/2007
Date registered
12/04/2007
Date last updated
23/04/2015
Titles & IDs
Public title
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Query!
Scientific title
International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg
Query!
Secondary ID [1]
0
0
2006-005270-47
Query!
Secondary ID [2]
0
0
91656
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Beyond
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1b (Betaseron, BAY86-5046)
Treatment: Drugs - Interferon beta-1b (Betaseron, BAY86-5046)
Treatment: Drugs - Interferon beta-1b (Betaseron, BAY86-5046)
Experimental: IFNB-1b 500 mcg - Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
Experimental: IFNB-1b 250 mcg - Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
Experimental: IFNB-1b 250 mcg* - Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day
\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Treatment: Drugs: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Treatment: Drugs: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Treatment: Drugs: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.
Phase B: All patients will receive 500µg s.c.every other day (open-label).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Flu-like-syndrome
Query!
Assessment method [1]
0
0
The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
Query!
Timepoint [1]
0
0
309 days
Query!
Primary outcome [2]
0
0
Injection-site Reactions
Query!
Assessment method [2]
0
0
The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Query!
Timepoint [2]
0
0
309 days
Query!
Primary outcome [3]
0
0
Liver Enzyme Elevations
Query!
Assessment method [3]
0
0
The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Query!
Timepoint [3]
0
0
309 days
Query!
Primary outcome [4]
0
0
Hematological Abnormalities
Query!
Assessment method [4]
0
0
The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Query!
Timepoint [4]
0
0
309 days
Query!
Secondary outcome [1]
0
0
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
Query!
Assessment method [1]
0
0
Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.
Query!
Timepoint [1]
0
0
309 days
Query!
Eligibility
Key inclusion criteria
* Completion of the BEYOND study 306440 as scheduled
* Relapsing multiple sclerosis
* Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
* Females of child-bearing potential:
* Agreement to practice adequate contraception methods and
* Negative pregnancy test and
* No lactation
* Written informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Serious or acute heart diseases
* History of severe depression or suicide attempt
* Epilepsy not adequately controlled by treatment
* Known allergy to IFNs, to human albumin or to mannitol
* Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1420
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
- Kogarah
Query!
Recruitment hospital [2]
0
0
- Fitzroy
Query!
Recruitment hospital [3]
0
0
- Parkville
Query!
Recruitment hospital [4]
0
0
- Nedlands
Query!
Recruitment hospital [5]
0
0
- Liverpool
Query!
Recruitment hospital [6]
0
0
- Wyoming
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [4]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [5]
0
0
NSW 2170 - Liverpool
Query!
Recruitment postcode(s) [6]
0
0
NSW 2250 - Wyoming
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Delaware
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Louisiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Minnesota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Mexico
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Rhode Island
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Wisconsin
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Ciudad Auton. de Buenos Aires
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Córdoba
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Santa Fe
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Buenos Aires
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Niederösterreich
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Graz
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Innsbruck
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Linz
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Brussel
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Leuven
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Melsbroek
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Parana
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Pernambuco
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Rio Grande do Sul
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Sao Paulo
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Rio de Janeiro
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Alberta
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
British Columbia
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Nova Scotia
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Ontario
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Quebec
Query!
Country [54]
0
0
Denmark
Query!
State/province [54]
0
0
Aarhus
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Oulu
Query!
Country [56]
0
0
Finland
Query!
State/province [56]
0
0
Tampere
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Bretagne
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Gironde
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Clermont ferrand
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Dijon
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Lille
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Nancy
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Nantes
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Nice
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Nimes
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Toulouse
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Baden-Württemberg
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Bayern
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Brandenburg
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Hessen
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Mecklenburg-Vorpommern
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Niedersachsen
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Nordrhein-Westfalen
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Sachsen-Anhalt
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Sachsen
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Berlin
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Hamburg
Query!
Country [78]
0
0
Greece
Query!
State/province [78]
0
0
Attica
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
Thessaloniki
Query!
Country [80]
0
0
Hungary
Query!
State/province [80]
0
0
Budapest
Query!
Country [81]
0
0
Hungary
Query!
State/province [81]
0
0
Györ
Query!
Country [82]
0
0
Hungary
Query!
State/province [82]
0
0
Miskolc
Query!
Country [83]
0
0
Hungary
Query!
State/province [83]
0
0
Pecs
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Zalaegerszeg-Pozva
Query!
Country [85]
0
0
Ireland
Query!
State/province [85]
0
0
Cork
Query!
Country [86]
0
0
Ireland
Query!
State/province [86]
0
0
Dublin
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Ashkelon
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Haifa
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Jerusalem
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Tel Hashomer
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Tel-Aviv
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Zerifin
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Torino
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Bari
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Firenze
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Milano
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Padova
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Roma
Query!
Country [99]
0
0
Latvia
Query!
State/province [99]
0
0
Riga
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Breda
Query!
Country [101]
0
0
Netherlands
Query!
State/province [101]
0
0
Nijmegen
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
Sittard
Query!
Country [103]
0
0
Norway
Query!
State/province [103]
0
0
Bergen
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Gdansk
Query!
Country [105]
0
0
Poland
Query!
State/province [105]
0
0
Katowice
Query!
Country [106]
0
0
Poland
Query!
State/province [106]
0
0
Lodz
Query!
Country [107]
0
0
Poland
Query!
State/province [107]
0
0
Poznan
Query!
Country [108]
0
0
Poland
Query!
State/province [108]
0
0
Warszawa
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Wroclaw
Query!
Country [110]
0
0
Russian Federation
Query!
State/province [110]
0
0
Moskva
Query!
Country [111]
0
0
Russian Federation
Query!
State/province [111]
0
0
Nizhy Novgorod
Query!
Country [112]
0
0
Russian Federation
Query!
State/province [112]
0
0
Novosibirsk
Query!
Country [113]
0
0
Russian Federation
Query!
State/province [113]
0
0
Sankt-Peterburg
Query!
Country [114]
0
0
Russian Federation
Query!
State/province [114]
0
0
St. Petersburg
Query!
Country [115]
0
0
Russian Federation
Query!
State/province [115]
0
0
Yaroslavl
Query!
Country [116]
0
0
Slovenia
Query!
State/province [116]
0
0
Ljubljana
Query!
Country [117]
0
0
Slovenia
Query!
State/province [117]
0
0
Maribor
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Barcelona
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Malaga
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Sevilla
Query!
Country [121]
0
0
Sweden
Query!
State/province [121]
0
0
Stockholm
Query!
Country [122]
0
0
Sweden
Query!
State/province [122]
0
0
Uppsala
Query!
Country [123]
0
0
Switzerland
Query!
State/province [123]
0
0
Bern
Query!
Country [124]
0
0
Switzerland
Query!
State/province [124]
0
0
St. Gallen
Query!
Country [125]
0
0
Ukraine
Query!
State/province [125]
0
0
Donetsk
Query!
Country [126]
0
0
Ukraine
Query!
State/province [126]
0
0
Kharkiv
Query!
Country [127]
0
0
Ukraine
Query!
State/province [127]
0
0
Kiev
Query!
Country [128]
0
0
Ukraine
Query!
State/province [128]
0
0
Lviv
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00459667
Query!
Trial related presentations / publications
Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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 are available at
https://clinicaltrials.gov/study/NCT00459667
Download to PDF
Show all queries