Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— ADIMS  

Official title:

A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099370
• Other study ID #: US-BGT-13-10458
• Status: Completed
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2020
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).

• Aged 18 at the time of informed consent.

• Must have a relapsing form of MS.

• Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

• Progressive form of MS

• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.

• Female subjects considering becoming pregnant while in the study.

• Female subjects who are currently pregnant or breast-feeding.

• Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol.

• Any other reason that, in opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	USF Carol and Frank Morsani Center for Advanced Healthcare	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence rates to Tecfidera		over one year