Multiple SclerosisNCT02454907
The Use of Technology to Improve MS Clinical Trials and Patient Care
A study testing Communication with the clinic in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Communication with the clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This research is being done to study if a relapse questionnaire for people with multiple sclerosis (MS) may help more easily determine if a relapse has occurred.
A further goal of this study is to determine if receiving periodic messages from the doctor's office, as well as having the direct contact information of a person in the office, improves the care of the patients and their experience thereof.
- Conditions
- Multiple Sclerosis
- Being tested
- Communication with the clinic
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | One kind of communication with the clinic will be used. Receives: Other: Communication with the clinic |
| Experimental | Experimental | A different kind of communication with the clinic will be used. Receives: Other: Communication with the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded
The primary and secondary outcomes for this study are blinded.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study start31 Jul 2018
- Primary completion9 Apr 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Ellen Mowry, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454907
- Sponsor's protocol ID
- NA_00083614
- Status last verified
- Jun 2026
- First submitted
- 22 May 2015
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Technology to Improve MS Clinical Trials and Patient Care
- ClinicalTrials.gov ID
- NCT02454907
- Acronym / sponsor ID
- NA_00083614
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research is being done to study if a relapse questionnaire for people with multiple sclerosis (MS) may help more easily determine if a relapse has occurred.
A further goal of this study is to determine if receiving periodic messages from the doctor's office, as well as having the direct contact information of a person in the office, improves the care of the patients and their experience thereof.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Communication with the clinicOne kind of communication with the clinic will be used. |
| Experimental | Experimental | Other: Communication with the clinicA different kind of communication with the clinic will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication with the clinicOver the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office. | Other | Control, Experimental |
Primary outcome
Blinded
Time frame: 96 weeks
The primary and secondary outcomes for this study are blinded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Mowry principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication with the clinic in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinded (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.