Safety of RG2077 in Patients With Multiple Sclerosis - Full Text View

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)
ClinicalTrials.gov Identifier:	NCT00076934

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

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

Genetics Home Reference related topics: Friedreich ataxia

MedlinePlus related topics: Autoimmune Diseases Multiple Sclerosis

Drug Information available for: Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	20
Study Start Date:	January 2003

Arms	Assigned Interventions
1: Experimental Participants receive Regimen 1 for 4 months	Drug: RG2077 (CTLA4-IgG4m) RG2077
2: Experimental Participants receive Regimen 2 for 4 months	Drug: RG2077 (CTLA4-IgG4m) RG2077
3: Experimental Participants receive Regimen 3 for 4 months	Drug: RG2077 (CTLA4-IgG4m) RG2077
4: Experimental Participants receive Regimen 4 for 4 months	Drug: RG2077 (CTLA4-IgG4m) RG2077

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076934

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Immune Tolerance Network

Investigators

Principal Investigator:

Samia J. Khoury, MD

Brigham and Women's Hospital

More Information

No publications provided

Study ID Numbers:	ITN006AI
Study First Received:	February 6, 2004
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00076934 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Ataxia
MRI
MS

CTLA4-IgG4m
Costimulatory Signals
Autoimmune Disorders

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Ataxia
Demyelinating Autoimmune Diseases, CNS

Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Cytotoxic T-lymphocyte antigen 4
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009