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Safety of RG2077 in Patients With Multiple Sclerosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Safety of RG2077 in Patients With Multiple Sclerosis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety of RG2077 in Patients With Multiple Sclerosis Clinical research trials and Safety of RG2077 in Patients With Multiple Sclerosis health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Safety of RG2077 in Patients With Multiple Sclerosis. Safety of RG2077 in Patients With Multiple Sclerosis Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety of RG2077 in Patients With Multiple Sclerosis clinical trial. Participants oftentimes recieve the most expert healthcare available for their Safety of RG2077 in Patients With Multiple Sclerosis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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Safety of RG2077 in Patients With Multiple Sclerosis



Safety of RG2077 in Patients With Multiple Sclerosis

For Condition: Multiple Sclerosis,Multiple Sclerosis, Relapsing-Remitting
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Immune Tolerance Network
Synopsis: Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body’s immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS.
Details: Effective treatment of autoimmune disorders is likely to arise not from improved immunosuppression, but from improved understanding of the normal mechanisms that generate and maintain self-tolerance. This dose-escalation study will evaluate the safety of RG2077 (CTLA4-IgG4m) in patients with MS. RG2077 may block a T-cell costimulation pathway central to the pathophysiology of MS. Twenty-four patients with MS will be enrolled in this study. Each patient will participate in the study for 4 months. Participants will be assigned to one of four groups. Each group will receive a different dose of RG2077. Patients will be monitored for possible side effects of RG2077.
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Confirmed diagnosis of MS, defined as an MRI consistent with MS plus two separate clinical events, or one clinical event and MRI consistent with demyelination plus a second MRI demonstrating new lesions - Have declined all FDA approved therapies for MS
Total Enrollment: 24

Location and Contact Information:

Overall Study Official:
SamiaKhoury,  Principal Investigator,  Brigham and Women's Hospital

Brigham and Women's Hospital/Harvard Medical School
Boston,  Massachusetts,  02115
United States
 


Additional Information:
Study ID Numbers:
  ITN006AI; 
Study Start Date: January 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076934

Other Multiple Sclerosis Studies:
1. A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

2. Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis

3. Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

4. Safety of RG2077 in Patients With Multiple Sclerosis

5. Treatment of Multiple Sclerosis using Over the Counter Inosine

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Safety of RG2077 in Patients With Multiple Sclerosis

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