BEYOND Pilot Study

The purpose of this study is to valuate safety and tolerability of Betaseron.


Eligibility Criteria:
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