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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2006-005270-47
Secondary ID [2] 0 0
91656
Universal Trial Number (UTN)
Trial acronym
Beyond
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 (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).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Flu-like-syndrome - The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
Timepoint [1] 0 0
309 days
Primary outcome [2] 0 0
Injection-site Reactions - The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Timepoint [2] 0 0
309 days
Primary outcome [3] 0 0
Liver Enzyme Elevations - The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Timepoint [3] 0 0
309 days
Primary outcome [4] 0 0
Hematological Abnormalities - The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Timepoint [4] 0 0
309 days
Secondary outcome [1] 0 0
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values - 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.
Timepoint [1] 0 0
309 days

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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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?



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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Kogarah
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- Fitzroy
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- Parkville
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- Nedlands
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- Liverpool
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- Wyoming
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
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NSW 2170 - Liverpool
Recruitment postcode(s) [6] 0 0
NSW 2250 - Wyoming
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 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.
Trial website
https://clinicaltrials.gov/show/NCT00459667
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
Other publications