Multiple SclerosisOCTIMSNCT02907281
Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
An observational study of Multiple Sclerosis and RRMS, run by Novartis Pharmaceuticals at 28 sites in 12 countries.
Trial summary
This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS). Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, RRMS
- What is being tested?
- Observational
- How many people
- 414 participants
- Where
- 28 sitesin 12 countries
- Study dates
- 29 May 2012to 24 Jul 2017
- 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: Multiple Sclerosis patients and healthy volunteers
Multiple sclerosis patients
- A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsing-remitting course
- MS disease duration of more than one year (from diagnosis of MS) before study entry
Healthy volunteers
- Matched to MS patients based on age, gender, ethnicity and visual refraction
Trial locations and contacts
28 sites in 12 countries.
28 sites in 12 countries
Italy7 sites
Novartis Investigative Site
Bari, 70124
Novartis Investigative Site
Cagliari, CA, 09126
Novartis Investigative Site
Genova, 16132
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Montichiari, 25018
Novartis Investigative Site
Padova, 35128
Novartis Investigative Site
Roma, 189
United States5 sites
Novartis Investigative Site
Baltimore, Maryland, 21287
Novartis Investigative Site
Iowa City, Iowa, 52242
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104-4283
Novartis Investigative Site
San Francisco, California, 94143-0359
Novartis Investigative Site
Torrance, California, 90509-2004
Spain4 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 8036
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Valencia, Valencia, 46026
Australia2 sites
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Parkville, Victoria, 3065
Canada2 sites
Novartis Investigative Site
Calgary, Alberta, T2N 4Z1
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2J2
Germany2 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Magdeburg, 39120
About this study
Official title: A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS).
Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.
- Conditions
- Multiple Sclerosis, RRMS
- Being tested
- Observational
- Keywords
- Multiple sclerosis,, MS,, Optical coherence tomography, OCT,, RRMS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patients | Multiple sclerosis patients Receives: Other: Observational | |
| Healthy volunteers | Healthy volunteers Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retinal Nerve Fiber Layer Thickness (RNFL)
evaluate change in RNFL thickness in relapsing remitting multiple sclerosis (RRMS) patients followed for up to 36 months compared to a group of reference subjects (without neurologic or ophthalmic disease) to determine whether the technology is sufficiently sensitive to disease and to change over time.
Measured: 36 months
Secondary outcomes (4)
Correlation of change in macular volume with change in brain volume
To evaluate the correlation of change in macular volume with change in brain volume as measured by MRI in RRMS patients followed for up to 36 months.
Measured: 36 months
Assess reproducibility of RNFL thickness on optical coherence tomography
To evaluate short-team reproducibility of the RNFL thickness measure at study start by test/re-test estimation after a 4-week interval in RRMS patients and reference subjects (without neurologic or ophthalmic disease).
Measured: 4 weeks
Change in macular volume over 36 months
To evaluate change in macular volume over 36 months in RRMS patients compared to a group of reference subjects (without neurologic or ophthalmic disease).
Measured: 36 months
Correlation of change in RNFL thickness with change in brain volume
To evaluate the correlation of change in RNFL thickness with change in brain volume as measured by magnetic resonance imaging (MRI) in RRMS patients followed for up to 36 months.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start29 May 2012
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
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 Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907281
- Sponsor's protocol ID
- CFTY720D2319
- Other IDs
- 2011-001437-16
- Acronym
- OCTIMS
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02907281
- Acronym / sponsor ID
- OCTIMS / CFTY720D2319
- Conditions
- Multiple Sclerosis, RRMS
- Keywords
- Multiple sclerosis,, MS,, Optical coherence tomography, OCT,, RRMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2012 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 20 Sep 2016 (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 is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS).
Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients | – | Other: ObservationalMultiple sclerosis patients |
| Healthy volunteers | – | Other: ObservationalHealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis patients and healthy volunteers
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 |
|---|---|---|
| ObservationalObservational | Other | Healthy volunteers, Multiple sclerosis patients |
Primary outcome
Change in Retinal Nerve Fiber Layer Thickness (RNFL)
Time frame: 36 months
evaluate change in RNFL thickness in relapsing remitting multiple sclerosis (RRMS) patients followed for up to 36 months compared to a group of reference subjects (without neurologic or ophthalmic disease) to determine whether the technology is sufficiently sensitive to disease and to change over time.
4 secondary outcomes
Correlation of change in macular volume with change in brain volume
Time frame: 36 months
Assess reproducibility of RNFL thickness on optical coherence tomography
Time frame: 4 weeks
Change in macular volume over 36 months
Time frame: 36 months
Correlation of change in RNFL thickness with change in brain volume
Time frame: 36 months
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 17 Nov 2017.
- Individual participant dataSharing planned: Yes
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
28 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and RRMS, run by Novartis Pharmaceuticals at 28 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, United States, Spain, Australia, Canada and 7 more countries. 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?
Change in Retinal Nerve Fiber Layer Thickness (RNFL) (time frame: 36 months). 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 17 Nov 2017.