NCT02099370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

March 21, 2014

Last Update Submit

April 1, 2020

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisTecfidera(R)Oral medicationAdherence

Outcome Measures

Primary Outcomes (1)

  • adherence rates to Tecfidera

    over one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample of Multiple Sclerosis patients started on Tecfidera

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Multiple Sclerosis Center Director

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 28, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

US(1)