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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Multiple Sclerosis Center

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glatiramer Acetate

Drug

20 mg daily subcutaneous injection. Six-month duration.

Other names: Copaxone

Primary outcomes

Production of inflammatory cytokines by monocytes and naive T cells.

Time frame: 0, 1, 2, 4, 6 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

National Multiple Sclerosis Society
Teva Neuroscience, Inc.

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Jan 8, 2009
Registry last updated: Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed