A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy
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ClinicalTrials.gov Identifier: NCT00238654 |
Recruitment Status
:
Completed
First Posted
: October 13, 2005
Last Update Posted
: April 12, 2011
|
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Condition or disease |
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Multiple Sclerosis |
Study Type : | Observational |
Actual Enrollment : | 257 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 Start Date : | May 2003 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2008 |

- Adherence of self-injection assessed by self-report at each follow-up visit [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Male or Female, 18 years of age or older, with diagnosis of RRMS
- Naive to treatment or previously treated with an IFN.
Exclusion Criteria:
- Not eligible for treatment based on clinical criteria and current indication.
- Unable to respond to surveys or provide informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238654
Study Director: | MerriKay Oleen-Burkey, Ph.D. | Teva Neuroscience, Inc. |
Additional Information:
Responsible Party: | Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience |
ClinicalTrials.gov Identifier: | NCT00238654 History of Changes |
Other Study ID Numbers: |
PM08 |
First Posted: | October 13, 2005 Key Record Dates |
Last Update Posted: | April 12, 2011 |
Last Verified: | April 2011 |
Additional relevant MeSH terms:
Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Glatiramer Acetate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Antirheumatic Agents |