Safety of RG2077 in Patients With Multiple Sclerosis
A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-sclerosis
Started Jan 2003
Typical duration for phase_1 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 6, 2004
CompletedFirst Posted
Study publicly available on registry
February 9, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedMarch 27, 2017
March 1, 2017
February 6, 2004
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety assessment including a MRI, neurological and physical examinations
Throughout study
Secondary Outcomes (1)
Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI
Throughout study
Study Arms (4)
1
EXPERIMENTALParticipants receive Regimen 1 for 4 months
2
EXPERIMENTALParticipants receive Regimen 2 for 4 months
3
EXPERIMENTALParticipants receive Regimen 3 for 4 months
4
EXPERIMENTALParticipants receive Regimen 4 for 4 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Immune Tolerance Network (ITN)collaborator
- Repligen Corporationcollaborator
Study Sites (1)
Brigham and Women's Hospital/Harvard Medical School
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 18794494RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samia J. Khoury, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2004
First Posted
February 9, 2004
Study Start
January 1, 2003
Study Completion
February 1, 2006
Last Updated
March 27, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
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.