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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00238654
First received: October 12, 2005
Last updated: April 8, 2011
Last verified: April 2011
  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 ] [ 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
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:

  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
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

Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
  More Information

Additional Information:
No publications provided

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

ClinicalTrials.gov processed this record on September 16, 2014