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