Clinical trial NCT00076934: Safety of RG2077 in Patients With Multiple Sclerosis
Official title: A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Keywords: Ataxia
MRI
MS
CTLA4-IgG4m
Costimulatory Signals
Autoimmune Disorders
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Immune Tolerance Network (ITN)
name: Repligen Corporation
First posted: 2004-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Safety assessment including a MRI, neurological and physical examinations
timeFrame: Throughout study
Secondary outcomes:
measure: Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI
timeFrame: Throughout study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital/Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Samia J. Khoury, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.