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Disease Category: Lupus

Trial Information

ABOUT LUPUS

More than two million individuals in North America have systemic lupus erythematosus (SLE). SLE can occur at any age in either sex. Among adults with SLE, women are 10-15 times more likely to be affected than adult men.

SYMPTOMS

• Achy and swollen joints
• Fever more than 100 degrees (F)
• Prolonged or extreme fatigue
• Rash or lesions

TREATMENT

• NSAIDS, nonsteroidal anti-inflammatory drugs, are used to relieve achy joints and arthritis in SLE when pain is limited and organs are not affected.
• Antimalarial drugs, such as hydroxycholoquine, are often prescribed for arthritis or skin problems.
• Corticosteroids, such as prednisone, are typically used when SLE affects one or more internal organs.
• Immunosuppressive agents such as azathioprine, methotrexate, cyclophosphamide, cyclosporine and mycophenolate mofetil help control the overactive but misdirected immune system in SLE patients.

THE MI-CP152 STUDY

The MI-CP152 Study is seeking individuals with moderate to severe systemic lupus erythematosus (SLE). The purpose of the MI-CP152 Study is to evaluate the safety and tolerability of an investigationalmedication in patients diagnosed with severe SLE.

Participation in the MI-CP152 Study includes as may as 24 visits to a local physicians office over a period of up to one year.

Participants will recieve study-related medical care at no cost including:

• Study-related health exams
• Lab tests
• Study medication
• Reimbursement for time and travel

Patient Inclusion Criteria = POTENTIAL STUDY VOLUNTEERS MUST:

• Be 18 or older
• Have a diagnosis of systemic lupus erythematosus with at least 4 of the 11 ACR criteria for SLE
• Weigh less than 265 pounds
• Be currently taking 20 mg/day or less of prednisone
• Not have taken the following doses of medication within the last 28 days:
• Hydroxchloroquine >600 mgs/day
• Mycophenolate mofetil >3 g/day
• Methotrexate >25 mg/week
• Leflunomide >20 mg/day
• Azathioprine >3 mg/kg/day
• Cyclophosphamide Any dosage
• Cyclosporine Any dosage
• Thalidomide Any dosage
• Not have a history of severe viral infections
• Not have been vaccinated with live attenuated viruses within the last 28 days
• Not have a history of cancer or active tuberculosis

Patient Exclusion Criteria = please see inclusion criteri

Sara McGilvary, CCRC
Clinical Research of West Florida, Inc.
2147 NE Coachman Road
Clearwater FL 33765
Phone: 727-466-0078
Fax: 727-461-7793
EMail: smcgilvary@crwf.com

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Research Center Information: Clinical Research of West Florida, Inc.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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