Phase 3
Completed N=1,420
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Multiple Sclerosis, Relapsing-Remitting
Source: ClinicalTrials.gov NCT00459667 ↗
Enrolled (actual)
1,420
Serious AEs
2.3%
Results posted
Aug 2009
Primary outcomePrimary: Flu-like-syndrome — 17.4; 15.8; 31.1 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flu-like-syndrome |
17.4; 15.8; 31.1 | — |
| PRIMARY Injection-site Reactions |
31.7; 26.2; 31.7 | — |
| PRIMARY Liver Enzyme Elevations |
2.7; 1.2; 3.9; 2.0; 1.4; 3.9 | — |
| PRIMARY Hematological Abnormalities |
0.5; 1.9; 1.7; 0.5; 1.2; 2.2 | — |
| SECONDARY Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values |
26.6; 21.7; 16.6; 16.5; 12.4; 2.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00459667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.