BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
Results by group
Flu-like-syndrome
309 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 500 mcg | 17.4 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 15.8 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 31.1 Percentage of participants | 180 |
IFNB-1b 500 mcg
IFNB-1b 250 mcg
IFNB-1b 250 mcg*
Number of patients w/ Flu-Like-Syndrome 17.4 (95% CI 14.4–20.7)
Injection-site Reactions
309 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 500 mcg | 31.7 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 26.2 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 31.7 Percentage of participants | 180 |
IFNB-1b 500 mcg
IFNB-1b 250 mcg
IFNB-1b 250 mcg*
number of patients w/ IS reactions. 31.7 (95% CI 28.0–35.7)
Liver Enzyme Elevations
309 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 500 mcg | 2.7 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 1.2 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 3.9 Percentage of participants | 180 | |
| IFNB-1b 500 mcg | 2.0 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 1.4 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 3.9 Percentage of participants | 180 | |
| IFNB-1b 500 mcg | 2.6 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 1.7 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 4.4 Percentage of participants | 180 |
Hematological Abnormalities
309 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 500 mcg | 0.5 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 1.9 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 1.7 Percentage of participants | 180 | |
| IFNB-1b 500 mcg | 0.5 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 1.2 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 2.2 Percentage of participants | 180 | |
| IFNB-1b 500 mcg | 1.5 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 0.6 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 0 Percentage of participants | 180 | |
| IFNB-1b 500 mcg | 0.7 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 0.2 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 0.6 Percentage of participants | 180 | |
| IFNB-1b 500 mcg | 1.2 Percentage of participants | 586 | |
| IFNB-1b 250 mcg | 1.1 Percentage of participants | 645 | |
| IFNB-1b 250 mcg* | 0 Percentage of participants | 180 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| IFNB-1b 500 mcg | 586 | 11 (1.9%) | |
| IFNB-1b 250 mcg | 645 | 16 (2.5%) | |
| IFNB-1b 250 mcg* | 180 | 6 (3.3%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Flu-like-syndrome
309 days
SafetyInjection-site Reactions
309 days
SafetyLiver Enzyme Elevations
309 days
Hematological Abnormalities
309 days
The primary variables are the frequencies of the following events:
Other measures (1)
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
309 days
Immune response
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
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
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
May 2007
Main results due
Mar 2008
Finished
Mar 2008
Results posted
Aug 2009