Multiple Sclerosis, Relapsing-Remitting Clinical Trial
— BeyondOfficial 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
Verified date | April 2015 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1420 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 309 days | Yes |
Primary | Injection-site Reactions | The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition. | 309 days | Yes |
Primary | Liver Enzyme Elevations | The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition. | 309 days | Yes |
Primary | Hematological Abnormalities | The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition. | 309 days | Yes |
Secondary | 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. | 309 days | No |
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