Status:
COMPLETED
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 inv...
Detailed Description
Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applyi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
1420 Patients enrolled
Trial Details
Trial ID
NCT00459667
Start Date
May 1 2007
End Date
March 1 2008
Last Update
April 23 2015
Active Locations (184)
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1
Birmingham, Alabama, United States, 35294-7340
2
Cullman, Alabama, United States, 35058
3
Phoenix, Arizona, United States, 85013
4
Tucson, Arizona, United States, 85741