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OpenTrials
Completed

NCT Number: NCT02099370

Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. adherence rates to Tecfidera

    Time frame: over one year

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Biogen

Registry information

Official study title

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

Acronym: ADIMS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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