NCT02408380

Brief Summary

This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 20, 2015

Last Update Submit

April 2, 2015

Conditions

Multiple Sclerosis

Keywords

biomarkerdisease progression

Outcome Measures

Primary Outcomes (1)

  • Change in expression of a biomarker signature

    12 months

Eligibility Criteria

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

Patients treated with Gilenya compared with age-matched healthy controls

You may qualify if:

  • Treatment with Gilenya

You may not qualify if:

  • Subject is under 18 or over 65.
  • Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
  • Subject cannot communicate reliably with investigator.
  • Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cryopreserved peripheral blood mononuclear cells.

MeSH Terms

Conditions

Multiple SclerosisDisease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Haegert, MD

    MUHC research institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Fitz-Gerald, MSc.

CONTACT

514-398-7192leslie.fitz-gerald@mail.mcgill.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 3, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

CA(1)