Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Gilenya (Fingolimod) on Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis

NCT02021162

Multiple Sclerosis Healthy

COMPLETED

Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)

NCT02408380

Multiple Sclerosis

UNKNOWN

Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.

NCT02225977

Multiple Sclerosis

COMPLETED

Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

NCT04667949

Relapsing Multiple Sclerosis (RMS)

COMPLETED PHASE4

Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

NCT00097760

Multiple Sclerosis, Relapsing-Remitting

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The biologic basis that determines disease progression in multiple sclerosis (MS) patients remains to be defined. We propose that a long term study of patients where inflammatory activity of the disease is expected to be controlled on treatment, will identify patients into cohorts of those whose disease is deemed to be stable with those patients whose disease has been deemed to progress. Once the two groups have been identified, it will then be possible to assess whether there are differences in biologic markers between the two groups. These markers would then have the potential to be used to monitor disease progression or be predictors for patient response to drug treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis-Relapsing-Remitting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gilenya treatment

Gilenya oral form once a day

Gilenya

Intervention Type DRUG

All patients will receive Gilenya

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gilenya

All patients will receive Gilenya

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fingolimod

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Deemed by the subject's treating physician to be a suitable candidate for Gilenya therapy in accordance with the Canadian Product Monograph for Gilenya
* has an overall EDSS not above 7.0
* is not currently receiving Gilenya
* is able to perform adequately for EDSS assessment and cognitive tests
* is able to undergo a MRI
* is able to provide blood samples