Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00819195
First received: December 16, 2008
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce anti-inflammatory type II monocyte development during treatment of MS, and if these antigen presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.


Condition Intervention
Multiple Sclerosis
Drug: Glatiramer acetate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Production of inflammatory cytokines by monocytes and naive T cells. [ Time Frame: 0, 1, 2, 4, 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Peripheral blood mononuclear cells (PBMC) Serum RNA


Enrollment: 17
Study Start Date: December 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RRMS
Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care
Drug: Glatiramer acetate
20 mg daily subcutaneous injection. Six-month duration.
Other Name: Copaxone
HC
Healthy control volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Relapsing-remitting multiple sclerosis patients at the UCSF Multiple Sclerosis Center.

Criteria

Inclusion Criteria:

  • Relapsing-remitting (RR) MS patients (McDonald criteria)
  • Ages 18-55
  • Males and females
  • EDSS score ≤5
  • No prior treatment with Copaxone
  • Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable, provided there is a washout period of at least one month

Exclusion Criteria:

  • Treatment with Tysabri, Novantrone or cyclophosphamide
  • Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or methotrexate)
  • Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819195

Locations
United States, California
UCSF Multiple Sclerosis Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Multiple Sclerosis Society
Teva Neuroscience, Inc.
Investigators
Principal Investigator: Scott S. Zamvil, M.D. Ph.D. UCSF Department of Neurology
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00819195     History of Changes
Other Study ID Numbers: 10-03877
Study First Received: December 16, 2008
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
relapsing-remitting
multiple sclerosis
Copaxone
glatiramer acetate
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Copolymer 1
Anti-Inflammatory Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014