BEYOND Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to valuate safety and tolerability of Betaseron.

Official Title
-----------------
Double-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMS

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: Betaseron (Interferon beta-1b, BAY86-5046)
* Drug: Betaseron (Interferon beta-1b, BAY86-5046)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Betaseron (Interferon beta-1b, BAY86-5046)<br>* 250 mcg<br>|
| Experimental: Arm 2<br> | Drug: Betaseron (Interferon beta-1b, BAY86-5046)<br>* 500 mcg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of IFNB-1b 500 mcg given subcutaneously (SC) QOD compared with the standard dose of 250 mcg QOD in patients with RRMS. |  | 8 Months |