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

History of Changes

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:

Genetics Home Reference related topics: multiple sclerosis

Drug Information available for: Glatiramer Glatiramer acetate

U.S. FDA Resources

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


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:

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

Sponsors and Collaborators

Teva Neuroscience, Inc.

Investigators


Study Director:	MerriKay Oleen-Burkey, Ph.D.	Teva Neuroscience, Inc.

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
Study First Received:	October 12, 2005
Last Updated:	April 8, 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

ClinicalTrials.gov processed this record on September 25, 2017

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