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Safety of RG2077 in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00076934
Recruitment Status : Completed
First Posted : February 9, 2004
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Repligen Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Drug: RG2077 (CTLA4-IgG4m) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : January 2003
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety assessment including a MRI, neurological and physical examinations [ Time Frame: Throughout study ]

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

Eligibility Criteria
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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
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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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
National Institute of Allergy and Infectious Diseases (NIAID) website  This link exits the ClinicalTrials.gov site
Division of Allergy, Immunology, and Transplantation (DAIT) website  This link exits the ClinicalTrials.gov site
Immune Tolerance Network (ITN) website  This link exits the ClinicalTrials.gov site

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY661
ImmPort study identifier is SDY661
Study protocol synopsis, -summary, -design, -adverse events, -medications,-demographics, - lab tests, -files  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.

Publications of Results:

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 Posted: February 9, 2004    Key Record Dates
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:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs