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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)
  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 MS 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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI [ Time Frame: Throughout study ]

Enrollment: 20
Study Start Date: January 2003
Study Completion Date: February 2006
Arms Assigned Interventions
Experimental: 1
Participants receive Regimen 1 for 4 months
Drug: RG2077 (CTLA4-IgG4m)
RG2077
Experimental: 2
Participants receive Regimen 2 for 4 months
Drug: RG2077 (CTLA4-IgG4m)
RG2077
Experimental: 3
Participants receive Regimen 3 for 4 months
Drug: RG2077 (CTLA4-IgG4m)
RG2077
Experimental: 4
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 (ITN)
Repligen Corporation
Investigators
Principal Investigator: Samia J. Khoury, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY661
ImmPort study identifier is SDY661
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ITN006AI/NMS02
TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
Study protocol synopsis; -schedule of assessments; data and reports; adverse event(s); -specimens availability; -manuscripts and abstracts  This link exits the ClinicalTrials.gov site
Identifier: ITN006AI/NMS02
TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00076934     History of Changes
Other Study ID Numbers: DAIT ITN006AI
NMS02 ( Other Identifier: ITN )
First Submitted: February 6, 2004
First Posted: February 9, 2004
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ataxia
MRI
MS
CTLA4-IgG4m
Costimulatory Signals
Autoimmune Disorders

Additional relevant MeSH terms:
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
Immunoglobulin G
Abatacept
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents