BEYOND Pilot Study
BEYOND Pilot Study
The purpose of this study is to valuate safety and tolerability of Betaseron.
Inclusion Criteria:

 Diagnosis of RRMS as defined by any of the following McDonald diagnostic criteria (McDonald
 et al 2001; see Appendix 16.1.1 [(Protocol Appendix 5]):

 -  Two relapses and objective clinical evidence (history or present) of at least 2
 lesions

 -  Two relapses and objective clinical evidence (history or present) of 1 lesion; and
 dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria) or 2 MRI T2
 lesions consistent with MS plus positive CSF.

 -  One relapse with objective clinical evidence (history or present) of at least 2
 lesions, and dissemination in time, demonstrated signs of disease activity ( new Gd+
 lesion or new T2 lesion) in an MRI scan at least 3 months after the onset of that
 clinical event.

 -  One relapse and objective clinical evidence (history or present) of 1 lesion, and
 dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria); or 2 MRI T2
 lesions consistent with MS plus positive CSF, and dissemination in time, demonstrated
 by signs of disease activity (new Gd+ lesion or new T2 lesion) in an MRI scan at least
 3 months after the onset of that clinical event.

 -  18 to 55 years of age

 -  Score of 0-5.5 on the Kurtzke Expanded Disability Status Scale' (EDSS; see
 Appendix 16.1.1 [Protocol Appendix 4])

 -  Naïve to immunomodulating therapies or previously treated with immunomodulating
 therapies other than any interferon (IFN) more than 30 days prior to the start of
 the study

 -  If female of child-bearing potential, agreement to practice adequate
 contraception methods (IUCD, condoms, oral contraceptives, or other adequate
 barrier contraception)

 -  Negative serum pregnancy test results.

 -  Signed and dated statement of informed consent

 Exclusion Criteria:

 -  Clinically significant heart disease such as uncontrolled cardiac dysrhythmia, angina
 pectoris, cardiomyopathy, or congestive heart failure

 -  History of severe depression, suicide attempts, or current suicidal ideations

 -  Clinically significant liver, renal, and bone marrow dysfunction as defined by any of
 the following laboratory evaluations:

 -  bone marrow dysfunction:

 -  Hb <8.5 g/dl

 -  WBC <2.5 x 109/L

 -  platelet count <125 x 109/L

 -  renal dysfunction: creatinine >1.8 mg/dL

 -  liver dysfunction:

 -  ASAT (SGOT) >3xupper limit of normal

 -  bilirubin >2x upper limit of normal

 -  Epilepsy not adequately controlled by treatment

 -  Any conditions that could interfere with the MRI or any other evaluation in the study

 -  Known allergy to human proteins including albumin and IFN, or to mannitol or
 gadolinium

 -  Participation in any clinical study within the past 30 days or use/intake of an
 investigational drug within the last 3 months prior to study entry

 -  Prior treatment with monoclonal antibody therapy, cladribine or total lymphoid
 irradiation

 -  Treatment with cytotoxic or immunosuppressive therapies (except systemic steroid or
 adrenocorticotropic hormone [ACTH]) within 6 months prior to study entry; or systemic
 steroid or ACTH within 1 month prior to study entry

 -  Presence of monoclonal gammopathy

 -  Inability to tolerate both NSAIDs and acetaminophen

 -  Pregnancy or lactation

 -  History of alcohol or drug abuse

 -  Inability to administer subcutaneous injections either by self or by caregiver

 -  Medical, psychiatric or other conditions that compromise the patient's ability to give
 informed consent, to understand the patient information, to comply with the study
 protocol, or to complete the study