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Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients (ADIMS)

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ClinicalTrials.gov Identifier: NCT02099370
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : March 18, 2016
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Derrick Scott Robertson, University of South Florida

Brief 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.

Condition or disease
Multiple Sclerosis

Study Type : Observational
Actual Enrollment : 34 participants
Time Perspective: Prospective
Official Title: A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.
Study Start Date : March 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. adherence rates to Tecfidera [ Time Frame: over one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample of Multiple Sclerosis patients started on Tecfidera
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099370


Locations
United States, Florida
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Biogen

Responsible Party: Derrick Scott Robertson, MD, Multiple Sclerosis Center Director, University of South Florida
ClinicalTrials.gov Identifier: NCT02099370     History of Changes
Other Study ID Numbers: US-BGT-13-10458
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Keywords provided by Derrick Scott Robertson, University of South Florida:
Multiple Sclerosis
Tecfidera(R)
Oral medication
Adherence

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs