A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy
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]
1 other identifier
observational
257
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2003
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedApril 12, 2011
April 1, 2011
5.2 years
October 12, 2005
April 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence of self-injection assessed by self-report at each follow-up visit
12 months
Eligibility Criteria
RRMS patient with treatment-naïve or treatment-experienced
You may qualify if:
- Male or Female, 18 years of age or older, with diagnosis of RRMS
- Naive to treatment or previously treated with an IFN.
You may not qualify if:
- Not eligible for treatment based on clinical criteria and current indication.
- Unable to respond to surveys or provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MerriKay Oleen-Burkey, Ph.D.
Teva Neuroscience, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 13, 2005
Study Start
May 1, 2003
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 12, 2011
Record last verified: 2011-04