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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
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