Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02343159
• Date of registration: 09/01/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
• Scientific title: A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.
• Date of first enrolment: February 28, 2015
• Target sample size: 84
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02343159
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- The candidate is a DMF-naïve patient

- Have a diagnosis of relapsing forms of MS and satisfy the approved therapeutic
indication for DMF

- Have a recent (i.e., within the previous 6 months) complete blood count with results
that do not preclude the patient's participation in the study, in the judgment of the
Investigator

Key Exclusion Criteria:

- Have comorbid conditions that preclude participation in the study, as determined by
the Investigator

- History of severe allergic or anaphylactic reactions or known drug hypersensitivity

- Are participating, planning to participate, or have participated in the Tecfidera
QuickStart Program

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Device: Medication Event Monitoring System (MEMS)

Behavioral: Adherence counseling

Drug: dimethyl fumarate

Primary Outcome(s)

Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1 [Time Frame: Month 12]

Secondary Outcome(s)

Compliance Rates at Month 6 and 12 [Time Frame: Month 6, Month 12]

Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1 [Time Frame: Month 12]

Multiple Sclerosis Impact Scale (MSIS-29) [Time Frame: Month 6, Month 12]

Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1 [Time Frame: Month 6]

Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1 [Time Frame: Month 6]

Persistence Rates at Months 6 and 12 [Time Frame: Month 6, Month 12]

Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0) [Time Frame: Month 6, Month 12]

Secondary ID(s)

109MS413

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02343159