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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238654
First Posted: October 13, 2005
Last Update Posted: April 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
  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

Condition Phase
Multiple Sclerosis Phase 4

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

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 Submitted: October 12, 2005
First Posted: October 13, 2005
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