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Safety of RG2077 in Patients With Multiple Sclerosis - Article


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Tuberous Sclerosis

Bourneville Disease; Bourneville Phakomatosis; cerebral sclerosis; Epiloia; sclerosis tuberosa; tuberose sclerosis


Clinical Trial: Safety of RG2077 in Patients With Multiple Sclerosis

This study is currently recruiting patients.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Study hypothesis: Treatment with RG2077 will arrest SLE if administered early in the course of MS and decrease accumulation of lesions on MRI.

Condition Treatment or Intervention Phase
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
 Drug: RG2077 (CTLA4-IgG4m)
Phase I

MedlinePlus related topics:  Multiple Sclerosis

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Official Title: A Phase I Study: Safety of One Dose Of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

Further Study Details: 
Primary Outcomes: Safety assessment including a MRI, neurological and physical examinations
Secondary Outcomes: Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI
Expected Total Enrollment:  24

Study start: January 2003

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

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

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

Location and Contact Information


Massachusetts
      Brigham and Women's Hospital/Harvard Medical School, Boston,  Massachusetts,  02115,  United States; Recruiting
Michelle Bikowski, RN  617-713-2008    mbikowski@partners.org 

Study chairs or principal investigators

Samia J. Khoury, MD,  Principal Investigator,  Brigham and Women's Hospital   

More Information

Study ID Numbers:  ITN006AI
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  February 6, 2004
ClinicalTrials.gov Identifier:  NCT00076934
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 13, 2008



Page Updated: October 3, 2005
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