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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
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease
Multiple Sclerosis

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
Study Population
RRMS patient with treatment-naïve or treatment-experienced
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 treatment based on clinical criteria and current indication.
  2. Unable to respond to surveys or provide informed consent.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
For more information about Multiple Sclerosis  This link exits the ClinicalTrials.gov site
For more information about Teva Neuroscience, Inc  This link exits the ClinicalTrials.gov site

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