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Safety of RG2077 in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00076934
First Posted: February 9, 2004
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Immune Tolerance Network (ITN)
Repligen Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
February 6, 2004
February 9, 2004
March 27, 2017
January 2003
Not Provided
Safety assessment including a MRI, neurological and physical examinations [ Time Frame: Throughout study ]
Safety assessment including a MRI, neurological and physical examinations
Complete list of historical versions of study NCT00076934 on ClinicalTrials.gov Archive Site
Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI [ Time Frame: Throughout study ]
Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI
Not Provided
Not Provided
 
Safety of RG2077 in Patients With Multiple Sclerosis
A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

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 MS if administered early in the course of MS and decrease accumulation of lesions on MRI.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
Drug: RG2077 (CTLA4-IgG4m)
RG2077
  • Experimental: 1
    Participants receive Regimen 1 for 4 months
    Intervention: Drug: RG2077 (CTLA4-IgG4m)
  • Experimental: 2
    Participants receive Regimen 2 for 4 months
    Intervention: Drug: RG2077 (CTLA4-IgG4m)
  • Experimental: 3
    Participants receive Regimen 3 for 4 months
    Intervention: Drug: RG2077 (CTLA4-IgG4m)
  • Experimental: 4
    Participants receive Regimen 4 for 4 months
    Intervention: Drug: RG2077 (CTLA4-IgG4m)
Viglietta V, Bourcier K, Buckle GJ, Healy B, Weiner HL, Hafler DA, Egorova S, Guttmann CR, Rusche JR, Khoury SJ. CTLA4Ig treatment in patients with multiple sclerosis: an open-label, phase 1 clinical trial. Neurology. 2008 Sep 16;71(12):917-24. doi: 10.1212/01.wnl.0000325915.00112.61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00076934
DAIT ITN006AI
NMS02 ( Other Identifier: ITN )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • Immune Tolerance Network (ITN)
  • Repligen Corporation
Principal Investigator: Samia J. Khoury, MD Brigham and Women's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
March 2017

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