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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00819195

Enrollment

Registered

2009-01-08

Start date

2008-12-31

Completion date

2012-09-30

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

relapsing-remitting, multiple sclerosis, Copaxone, glatiramer acetate, MS

Brief summary

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.

Interventions

DRUGGlatiramer acetate

20 mg daily subcutaneous injection. Six-month duration.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Production of inflammatory cytokines by monocytes and naive T cells.	0, 1, 2, 4, 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026