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NCT00238654 Clinical Trial

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

Multiple Sclerosis Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238654
Other study ID # PM08
Secondary ID
Status Completed
Phase Phase 4
First received October 12, 2005
Last updated April 8, 2011
Start date May 2003
Est. completion date July 2008

Study information
Verified date April 2011
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 257
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 treatment based on clinical criteria and current indication.

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Teva Neuroscience, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence of self-injection assessed by self-report at each follow-up visit 12 months No
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