A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Shared Solutions® plus MS Center v. Shared Solutions®

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Copaxone®, Shared Solutions®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females, 18 years of age or older. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted). Beginning or restarting therapy with Glatiramer Acetate (Copaxone®). Willing and able to complete all procedures and evaluations related to the study. Willing to provide informed consent. Exclusion Criteria: Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®. Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study. Pregnant or trying to become pregnant, or breast feeding during the study. Previously participated in this study or another clinical research study in the past 30 days.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1

2

Arm Description

Shared Solutions®

Shared Solutions® and MS Center/Office Practice Partnership

Outcomes

Primary Outcome Measures

Adherence rate of Copaxone therapy by procedural intervention

Secondary Outcome Measures

Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance

Full Information

NCT ID

NCT00240006

First Posted

October 13, 2005

Last Updated

April 8, 2011

Sponsor

Teva Neuroscience, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00240006

Brief Title

A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone

Official Title

An Open Label, Prospective Parallel Cohort Study Comparing A 90-day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Teva Neuroscience, Inc.

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, Copaxone®, Shared Solutions®

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

307 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

Shared Solutions®

Arm Title

2

Arm Type

Experimental

Arm Description

Shared Solutions® and MS Center/Office Practice Partnership

Intervention Type

Procedure

Intervention Name(s)

Shared Solutions® plus MS Center v. Shared Solutions®

Intervention Description

Copaxone

Primary Outcome Measure Information:

Title

Adherence rate of Copaxone therapy by procedural intervention

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Males or females, 18 years of age or older. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted). Beginning or restarting therapy with Glatiramer Acetate (Copaxone®). Willing and able to complete all procedures and evaluations related to the study. Willing to provide informed consent. Exclusion Criteria: Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®. Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study. Pregnant or trying to become pregnant, or breast feeding during the study. Previously participated in this study or another clinical research study in the past 30 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MerriKay Oleen-Burkey, Ph.D.

Organizational Affiliation

Teva Neuroscience, Inc.

Official's Role

Study Director

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial