NCT02454907

Brief Summary

Many patients with multiple sclerosis (MS) experience "relapses" of disease activity during which they have increased numbness, weakness, visual problems, or other symptoms. If a person with MS has new symptoms that are concerning to them, their doctor may want to see them in the office in order to confirm that these symptoms are due to a true "relapse" of activity before starting relapse treatment. This requirement can be frustrating for patients, who may have to take time off from work or travel long distances for such unexpected doctors' visits. In this study, the investigators will use input from patients with MS and MS physicians to create a relapse questionnaire that can be used to confirm a relapse has occurred. The investigators will also evaluate if having a more direct line of communication with the provider's office improves overall patient care and satisfaction.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
0mo left

Started Jul 2018

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress99%
Jul 2018May 2026

First Submitted

Initial submission to the registry

May 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
3.2 years until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

7.8 years

First QC Date

May 22, 2015

Last Update Submit

January 29, 2026

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Blinded

    The primary and secondary outcomes for this study are blinded.

    96 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

One kind of communication with the clinic will be used.

Other: Communication with the clinic

Experimental

EXPERIMENTAL

A different kind of communication with the clinic will be used.

Other: Communication with the clinic

Interventions

Communication with the clinicOTHER

Over the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office.

ControlExperimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speakers
  • Relapsing-remitting MS (2010 criteria)
  • Expanded Disability Status Scale (EDSS) ≤6.0
  • Possession of a smartphone OR of a mobile telephone with text messaging AND an e-mail account AND web access OR willingness to be provided with, and utilize, a smartphone for the duration of the study
  • In the two years before screening:
  • at least two relapses, OR one relapse and two new lesions (unrelated to relapse symptoms) on magnetic resonance imaging (MRI), OR RRMS (MAGNIMS 2010 criteria) onset within the past year with no exposure to disease modifying therapies (DMT)
  • Patient is starting one of the following MS therapies: injectable (subcutaneous interferon beta or glatiramer acetate) or oral (fingolimod, teriflunomide, or dimethyl fumarate) therapies
  • Relapse and MRI activity occurred while untreated or despite one single treatment, and no change in therapy since that activity
  • Lives within 100 miles of Johns Hopkins Medical Center (Baltimore, MD)

You may not qualify if:

  • History of DMT exposure if MAGNIMS 2010 criteria used to enroll patients with disease onset in the past year, or change in MS therapy since qualifying relapse/MRI criteria occurred

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, 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 Officials

  • Ellen Mowry

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 27, 2015

Study Start

July 31, 2018

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

US(1)