The BEYOND study will try to answer 2 questions:

• Is treatment with interferon-1b 500 micrograms safe, tolerable and more effective than treatment with interferon-1b 250 micrograms? There is evidence from other studies that interferon-1b is more efficacious when increasing the dose. On the other hand, an increased dose may lead to more side effects which might also be more severe. This study will find out whether a higher efficacy can be shown when administering the higher dose and whether this effect will justify possible increases in side effects. This relationship is called risk-benefit ratio; it will be assessed for both doses of interferon-1b.
• Is treatment with interferon-1b safe, tolerable and more efficacious than treatment with Copaxone® (Glatiramer Acetate) 20 mg?

Condition	Treatment or Intervention	Phase
Multiple Sclerosis	Drug: Interferon Beta 1b  Drug: Glatiramer Acetate	Phase III

Further Study Details: 

Primary Outcomes: Prime objective: For IFNB-1b, comparison of a 500µg (16 MIU) dose to the currently approved dose (250 µg; 8 MIU), s.c. e.o.d., with regard to safety, tolerability and efficacy in patients with relapsing remitting MS (RRMS).
Secondary Outcomes: Co-prime objective: Comparison of the safety, tolerability and efficacy of IFNB-1b e.o.d. and Copaxone 20 mg given s.c. o.d.; Time to confirmed EDSS progression; MRI: Change from screening in volume of black holes after 104 weeks.
Expected Total Enrollment:  2100

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with relapsing-remitting MS

Exclusion Criteria:

• Prior treatment for MS

BEYOND Study Information      800-788-1467 

Alabama
      Birmingham,  Alabama,  35249,  United States; Recruiting
      Cullman,  Alabama,  35058,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85013,  United States; Recruiting
      Tucson,  Arizona,  85741,  United States; Recruiting
California
      Sacramento,  California,  95817,  United States; Recruiting
      Berkeley,  California,  94705,  United States; Recruiting
      San Francisco,  California,  94117,  United States; Recruiting
      La Jolla,  California,  92037,  United States; Recruiting
Colorado
      Englewood,  Colorado,  80113,  United States; Recruiting
      Fort Collins,  Colorado,  80528,  United States; Recruiting
Connecticut
      Derby,  Connecticut,  06418,  United States; Recruiting
Delaware
      Wilmington,  Delaware,  19806,  United States; Recruiting
District of Columbia
      Washington,  District of Columbia,  20037,  United States; Recruiting
Florida
      Maitland,  Florida,  32751,  United States; Recruiting
      Tampa,  Florida,  33609,  United States; Recruiting
      Tampa,  Florida,  33606,  United States; Recruiting
      Miami,  Florida,  33136,  United States; Recruiting
Georgia
      Augusta,  Georgia,  30912,  United States; Recruiting
      Atlanta,  Georgia,  30309,  United States; Recruiting
Illinois
      Chicago,  Illinois,  60637,  United States; Recruiting
Indiana
      Fort Wayne,  Indiana,  46805,  United States; Recruiting
      Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      Des Moines,  Iowa,  50314,  United States; Recruiting
Kansas
      Kansas City,  Kansas,  66160,  United States; Recruiting
Kentucky
      Lexington,  Kentucky,  40536,  United States; Recruiting
      Louisville,  Kentucky,  40202,  United States; Recruiting
Louisiana
      New Orleans,  Louisiana,  70112,  United States; Recruiting
      Shreveport,  Louisiana,  71130,  United States; Recruiting
Michigan
      Detroit,  Michigan,  48202,  United States; Recruiting
Minnesota
      Duluth,  Minnesota,  55805,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Recruiting
Nevada
      Reno,  Nevada,  89502,  United States; Recruiting
      Henderson,  Nevada,  89052,  United States; Recruiting
New Hampshire
      Lebanon,  New Hampshire,  03756,  United States; Recruiting
New Jersey
      Newark,  New Jersey,  07103,  United States; Recruiting
New Mexico
      Albuquerque,  New Mexico,  87131,  United States; Recruiting
New York
      Rochester,  New York,  14642,  United States; Recruiting
      Mineola,  New York,  11501,  United States; Recruiting
      New York,  New York,  10003,  United States; Recruiting
      Albany,  New York,  12208,  United States; Recruiting
      Stony Brook,  New York,  11794,  United States; Recruiting
North Carolina
      Durham,  North Carolina,  27710,  United States; Recruiting
      Winston Salem,  North Carolina,  27157,  United States; Recruiting
      Charlotte,  North Carolina,  28207,  United States; Recruiting
      High Point,  North Carolina,  27262,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  45219,  United States; Recruiting
      Columbus,  Ohio,  43221,  United States; Recruiting
Oregon
      Tualatin,  Oregon,  97062,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Rhode Island
      Providence,  Rhode Island,  02905,  United States; Recruiting
South Carolina
      Charleston,  South Carolina,  29425,  United States; Recruiting
Tennessee
      Nashville,  Tennessee,  37205,  United States; Recruiting
Texas
      San Antonio,  Texas,  78229,  United States; Recruiting
      Houston,  Texas,  77030,  United States; Recruiting
Virginia
      Fairfax,  Virginia,  22031,  United States; Recruiting
Washington
      Tacoma,  Washington,  98405,  United States; Recruiting
      Seattle,  Washington,  98101,  United States; Recruiting
Wisconsin
      Milwaukee,  Wisconsin,  53215,  United States; Recruiting
      Marshfield,  Wisconsin,  54449,  United States; Recruiting

Study ID Numbers:  306440
Record last reviewed:  December 2004
Last Updated:  December 16, 2004
Record first received:  December 15, 2004
ClinicalTrials.gov Identifier:  NCT00099502
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08