Safety of RG2077 in Patients With Multiple Sclerosis - Tabular View

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Safety of RG2077 in Patients With Multiple Sclerosis

This study has been completed.

Study NCT00076934. Last updated on June 6, 2008. Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Safety of RG2077 in Patients With Multiple Sclerosis

Official Title ^†

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

Brief Summary

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

Detailed Description

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. RG2077 may block a T cell costimulation pathway central to the pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each patient participates in the study for 4 months.

The dose-escalation portion of this study evaluated the safety of a single infusion of RG2077 (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated in the single infusion portion of the study were assigned to one of four groups. Each group received a different dose of RG2077. The second portion of the study will evaluate the safety of 4 doses of RG2077 in 4 additional patients. In the multiple infusion portion of the study, all patients will receive the same dose of RG2077. Patients will be monitored for possible side effects of RG2077.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Primary Outcome Measure ^†

Safety assessment including a MRI, neurological and physical examinations [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Condition ^†

Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting

Intervention ^†

Drug: RG2077 (CTLA4-IgG4m)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

January 2003

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00076934

Organization ID

ITN006AI

Secondary IDs ^††

Study Sponsor ^†

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^††

Immune Tolerance Network

Investigators ^†

Principal Investigator:

Samia J. Khoury, MD

Brigham and Women's Hospital

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

April 2007

First Received Date ^†

February 6, 2004

Last Updated Date

June 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.