A Study to Evaluate Readiness to Self-Inject on Adherence and Compliance to Copaxone® Therapy

Condition(s) targeted: Multiple Sclerosis

Intervention: Vary by stage of readiness (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

Official(s) and/or principal investigator(s):
MerriKay Oleen-Burkey, Ph.D., Study Director, Affiliation: Teva Neuroscience, Inc.

This study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. In addition, patients will have their self-injection observed and evaluated on up to three visits

Official title: A Multicenter, Open-Label, Two-Arm Prospective Study to Evaluate the Impact of Patient Readiness to Self-Inject on Outcomes When Using the Copaxone® Prefilled Syringes [The “READY” Trial]

Study design: Psychosocial, Longitudinal, Defined Population, Prospective Study

Detailed description: This is a prospective, open-label, two-arm study of subjects beginning therapy with Copaxone®. Patients may be MS treatment-naïve or MS treatment-experienced and changing therapy due to intolerance or lack of response. Patients respond to surveys and have their self-injections observed at study visits.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or Female, 18 years of age or older, with diagnosis of RRMS

2. Naive to treatment or previously treated with an IFN.

Exclusion Criteria:

1. Not eligible for treatement based on clinical criteria and current indication.

2. Unable to respond to surveys or provide informed consent.

Phoenix Neurological Associates, Phoenix, Arizona, United States

Coastal Neurological Medical Group, La Jolla, California, United States

Neurological Research Institute of the East Bay, Walnut Creek, California, United States

Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States

Neurology Associates, Maitland, Florida, United States

Neurologic Center of South Florida, Miami, Florida, United States

Neurology & Headache Specialists, Atlanta, Georgia, United States

Neurotrials Research, Atlanta, Georgia, United States

Neurological Associates, Boise, Idaho, United States

Midwest Neurology, Danville, Indiana, United States

Ruan Neurology Clinical Research Center, Des Moines, Iowa, United States

Lourdes MS Center, Layfette, Louisiana, United States

University of Minnesota, Minneapolis, Minnesota, United States

Neuroscience Center of Northern NJ, Morristown, New Jersey, United States

Neurology Consultants of Burlington County, Medford, New Jersey, United States

Neurological Consultations, Syracuse, New York, United States

Kinkel Neurologic Center, Williamsville, New York, United States

Alpha Neurology, Staten Island, New York, United States

Carolinas MS Center, Charlotte, North Carolina, United States

High Point Neurological Associates, High Point, North Carolina, United States

NeuroCare Center, Canton, Ohio, United States

Oak Clinic for MS, Uniontown, Ohio, United States

MS Center at Mercy, Oklahoma City, Oklahoma, United States

The Neurology Group, Norristown, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Advanced Neurosciences Institute, Nashville, Tennessee, United States

Associated Neurological Specialties, Austin, Texas, United States

MS Clinic of Central Texas, Round Rock, Texas, United States

Neurology Clinic of San Antonio, San Antonio, Texas, United States

Kelsey-Seybold Clinic, Houston, Texas, United States

Neurology Center of Fairfax, Fairfax, Virginia, United States

Neurological Associates, Richmond, Virginia, United States

For more information about Multiple Sclerosis

For more information about Teva Neuroscience, Inc

Starting date: May 2003
Ending date: May 2005
Last updated: December 23, 2005