A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy
This study has been completed.
Sponsor:
Teva Neuroscience, Inc.
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00238654
First received: October 12, 2005
Last updated: April 8, 2011
Last verified: April 2011
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Purpose
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
| Study Type: | Observational |
| Study Design: | 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] |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Adherence of self-injection assessed by self-report at each follow-up visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 257 |
| Study Start Date: | May 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
RRMS patient with treatment-naïve or treatment-experienced
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238654
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238654
Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
| Study Director: | MerriKay Oleen-Burkey, Ph.D. | Teva Neuroscience, Inc. |
More Information
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 |
| Study First Received: | October 12, 2005 |
| Last Updated: | April 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 30, 2016