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

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Teva Pharmaceuticals

Status and phase

Completed
Phase 4

Conditions

Multiple Sclerosis

Treatments

Procedure: Shared Solutions® plus MS Center v. Shared Solutions®

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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®.

Enrollment

307 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Males or females, 18 years of age or older.
  2. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
  3. Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
  4. Willing and able to complete all procedures and evaluations related to the study.
  5. Willing to provide informed consent.

Exclusion criteria

  1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
  2. 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.
  3. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
  4. Pregnant or trying to become pregnant, or breast feeding during the study.
  5. Previously participated in this study or another clinical research study in the past 30 days.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

307 participants in 2 patient groups

1
Experimental group
Description:
Shared Solutions®
Treatment:
Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
2
Experimental group
Description:
Shared Solutions® and MS Center/Office Practice Partnership
Treatment:
Procedure: Shared Solutions® plus MS Center v. Shared Solutions®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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