Safety of RG2077 in Patients With Multiple Sclerosis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 6, 2004

Last Updated Date

May 13, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety assessment including a MRI, neurological and physical examinations

Change History

Complete list of historical versions of study NCT00076934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI

Descriptive Information

Brief Title ^ICMJE

Safety of RG2077 in Patients With Multiple Sclerosis

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: RG2077 (CTLA4-IgG4m)

Study Arms / Comparison Groups

Experimental: Participants receive Regimen 1 for 4 months
Experimental: Participants receive Regimen 2 for 4 months
Experimental: Participants receive Regimen 3 for 4 months
Experimental: Participants receive Regimen 4 for 4 months

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076934

Responsible Party

Study ID Numbers ^ICMJE

DAIT ITN006AI

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Immune Tolerance Network

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP