Multiple Sclerosis-Relapsing-RemittingIGLOONCT02137707
Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya
An observational study of Multiple Sclerosis-Relapsing-Remitting, run by McGill University at 6 sites in Canada.
Trial summary
This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis-Relapsing-Remitting
- What is being tested?
- Gilenya
- Type of treatment
- Pill or oral medicine
- How many people
- 135 participants
- Where
- 6 sitesCanada
- Study dates
- Nov 2012to 30 Oct 2018
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with relapsing-remitting multiple sclerosis deemed by their treating physician to be a suitable candidate for Gilenya therapy
Who may be able to join
- 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
Who cannot join
- is over 65 years of age and under 18 years of age
- has less than 4 weeks of discontinuation with steroid treatment for a relapse.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Clinique Neuro Rive-Sud
Greenfield Park, Quebec
Dalhousie University Multiple Sclerosis Research Unit
Halifax, Nova Scotia
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years
This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.
Read the detailed description
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
- Multiple Sclerosis-Relapsing-Remitting
- Being tested
- Gilenya
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Gilenya, Fingolimod
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilenyaDrug
Also called fingolimod
All patients will receive Gilenya
| Study group | Role | What they receive |
|---|---|---|
| Gilenya treatment | Gilenya oral form once a day Receives: Drug: Gilenya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of disease progression of subjects treated with Gilenya over 2 years
Changes in number of new and enlarging T2 lesions by MRI between baseline and Year 2 will be compared with immune biomarkers (Teff:Treg ratio)
Measured: 2 years
Secondary outcomes (3)
Change in cognitive function in patients treated with Gilenya
changes in brain volume assessed by MRI between baseline and Year 2 will be compared with immune biomarkers
Measured: 2 years
Changes in biologic measures in patients treated with Gilenya
change in MTR MRI as assessment of myelin content will be compared with blood biomarkers
Measured: 2 years
Safety and tolerability of Gilenya therapy will be assessed
Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startNov 2012
- Primary completionNov 2017
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis-Relapsing-RemittingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Jack Antel, McGill University
- Investigators
- Jack Antel, MD, Principal investigator, McGill UniversityAmit Bar-Or, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137707
- Sponsor's protocol ID
- CFTY720DCA04T
- Acronym
- IGLOO
- Status last verified
- Nov 2018
- First submitted
- 12 May 2014
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghadiri M, Rezk A, Li R, Evans A, Giacomini PS, Barnett MH, Antel J, Bar-Or A. Pre-treatment T-cell subsets associate with fingolimod treatment responsiveness in multiple sclerosis. Sci Rep. 2020 Jan 15;10(1):356. doi: 10.1038/s41598-019-57114-2.
PubMed 31941953
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years
- ClinicalTrials.gov ID
- NCT02137707
- Acronym / sponsor ID
- IGLOO / CFTY720DCA04T
- Conditions
- Multiple Sclerosis-Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Gilenya, Fingolimod
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2012
- Primary completion
- Nov 2017 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 14 May 2014 (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.
This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gilenya treatment | – | Drug: GilenyaGilenya oral form once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsing-remitting multiple sclerosis deemed by their treating physician to be a suitable candidate for Gilenya therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- is over 65 years of age and under 18 years of age
- has less than 4 weeks of discontinuation with steroid treatment for a relapse.
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 |
|---|---|---|
| GilenyaAlso: fingolimodAll patients will receive Gilenya | Drug | Gilenya treatment |
Primary outcome
Determination of disease progression of subjects treated with Gilenya over 2 years
Time frame: 2 years
Changes in number of new and enlarging T2 lesions by MRI between baseline and Year 2 will be compared with immune biomarkers (Teff:Treg ratio)
3 secondary outcomes
Change in cognitive function in patients treated with Gilenya
Time frame: 2 years
Changes in biologic measures in patients treated with Gilenya
Time frame: 2 years
Safety and tolerability of Gilenya therapy will be assessed
Time frame: 2 years
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 9 Nov 2018.
- Derived from this study: PubMed 31941953Ghadiri M, Rezk A, Li R, Evans A, Giacomini PS, Barnett MH, Antel J, Bar-Or A. Pre-treatment T-cell subsets associate with fingolimod treatment responsiveness in multiple sclerosis. Sci Rep. 2020 Jan 15;10(1):356. doi: 10.1038/s41598-019-57114-2.
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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.
Jack Antel, MD principal investigator
McGill University
Amit Bar-Or, MD principal investigator
McGill University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis-Relapsing-Remitting, run by McGill University at 6 sites in Canada.
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 6 inclusion and 2 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Determination of disease progression of subjects treated with Gilenya over 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137707, which also lists 1 linked publication.
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 9 Nov 2018.