CLINICAL TRIAL: BETASERON/BETAFERON IN MS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The BEYOND FOLLOW-UP study will give patients taking part in the BEYOND study the opportunity to continue treatment with the interferon beta 1b high dose (500 'b5g) and will further investigate the safety and tolerability profile of interferon beta 1b 500 ug during long term treatment. This study will investigate expected side effects as well as unexpected side effects of the new, high dose of interferon beta 1b (500 ug) that might only be seen if medication is administered longer and in a larger patient population. As the risk-benefit ratio of the 500 ug dose will only be known after results of the BEYOND study will have been evaluated; in Phase A, every patient who has not yet been treated with the 500 ¿g dose during the preceding BEYOND trial will only receive treatment with the 250 ug dose of interferon beta-1b. All patients in the BEYOND FOLLOW-UP study will be given active treatment. It can be reasonably assumed that treatment with the 500 ¿g dose of interferon beta-1b is as least as effective as treatment with the currently approved dose (250 ¿g). In addition, you may also benefit from the extra medical care which will be part of the study including general physical examinations and laboratory checks.