Safety of RG2077 in Patients With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants receive Regimen 1 for 4 months

Group Type EXPERIMENTAL

RG2077 (CTLA4-IgG4m)

Intervention Type DRUG

RG2077

2

Participants receive Regimen 2 for 4 months

Group Type EXPERIMENTAL

RG2077 (CTLA4-IgG4m)

Intervention Type DRUG

RG2077

3

Participants receive Regimen 3 for 4 months

Group Type EXPERIMENTAL

RG2077 (CTLA4-IgG4m)

Intervention Type DRUG

RG2077

4

Participants receive Regimen 4 for 4 months

Group Type EXPERIMENTAL

RG2077 (CTLA4-IgG4m)

Intervention Type DRUG

RG2077

Interventions

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RG2077 (CTLA4-IgG4m)

RG2077

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samia J. Khoury, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital/Harvard Medical School

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 18794494 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

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.

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Document Type: Study protocol synopsis; -schedule of assessments; data and reports; adverse event(s); -specimens availability; -manuscripts and abstracts

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.

View Document