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Multiple Sclerosis

Drug under Investigation:  ABT-874

Purpose of Study:  To determine the safety and efficacy associated with 200mg of ABT-874 administered weekly subcutaneously vs 200mg every other week vs placebo over a period of 24 weeks in subjects with active RRMS or SPMS.

Inclusion Criteria:

  • Age 18 to 60 years old
  • Diagnosed with active RRMS (Relapsing-Remitting) or SPMS (Secondary Progressive), with at least one medically documented relapse within 12 months prior to screening
  • Must meet study-required criteria based on MRI scans at screening and baseline visits
  • Interferon, glatiramer acetate therapy, and natalizumab should be washed out for at least 3 months prior to dosing with study drug
  • Women of childbearing potential must agree to use 2 forms of contraception during the duration of the study

Exclusion Criteria:

  • PPMS (Primary progressive)
  • Use of immunosuppressive therapy within 6 months of enrolling
  • Use of mitoxantrone treatment within 12 months of enrolling
  • Use of systemic corticosteroid therapy within 1 month prior to first screening MRI
  • Severe, recurrent, or persistent infections or pneumonia or tuberculosis
  • History of lymphoma or leukemia, cutaneous squamous-cell or basal cell carcinoma, or other malignancy
  • Exacerbation of asthma requiring hospitalization within 10 years of enrolling
  • Recent history of substance abuse or psychiatric illness
  • Transfusion of any blood product received within 2 months of enrolling
  • Restricted concomitant medications: Avonex®, Betaseron®, Copaxone®, Cytoxan®, Gamimune®, Gammagard®, Sandoglobulin®, Iveegam®, Imuran®, Leukeran®, Rebif®, Sandimmune®, Neoral®, Tysabri®, Methotrexate, and any investigative agents

If you qualify, all study related care is provided at no charge including:

  • Study visits and study related procedures/tests
  • Laboratory tests
  • Study medication
  • Financial compensation for time/travel expenses

Inclusion/Exclusion Criteria Must Be Met

For more information, please contact:

Clinical Trials, Inc.
Two Lile Court, Suite 100
Little Rock, Arkansas  72205
Ph:  501-227-6179
Fax:  501-221-3426
info@clinicaltrialsinc.com

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