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

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.
 
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

Tracking Information
First Submitted Date October 12, 2005
First Posted Date October 13, 2005
Last Update Posted Date April 12, 2011
Study Start Date May 2003
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2011)
Adherence of self-injection assessed by self-report at each follow-up visit [ Time Frame: 12 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00238654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy
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]
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population RRMS patient with treatment-naïve or treatment-experienced
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2005)
257
Original Enrollment Same as current
Actual Study Completion Date July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00238654
Other Study ID Numbers PM08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience
Study Sponsor Teva Neuroscience, Inc.
Collaborators Not Provided
Investigators
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date April 2011