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Relapsing Remitting Multiple Sclerosis RRMSPhase 4PASSOSNCT01705236

A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®

A Phase 4 study testing Fingolimod in people with Relapsing Remitting Multiple Sclerosis RRMS, run by Novartis Pharmaceuticals at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a 3-year, prospective, multi-center, open-label study to describe the long term changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment with Fingolimod. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Fingolimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
10 sitesin 2 countries
Study dates
20 Aug 2012to 18 Feb 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patients eligible for inclusion in this study have to fulfill all of the following criteria:
  • Written informed consent must be obtained before any assessment is performed.
  • Male or female subjects aged 18-65 years.
  • Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4).
  • Patients with Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive (see Appendix 6).
  • Patients stable on immunomodulatory treatment with fingolimod for at least 1 month and at most 4 months prior to screening according to local label
  • Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
  • Sufficient ability to read, write, communicate and understand

Who cannot join

  • Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
  • Patients who have been treated with:
  • systemic corticosteroids or immunoglobulins within 1 month prior to screening;
  • immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to screening;
  • monoclonal antibodies (including natalizumab) within 3 months prior to screening;
  • mitoxantrone within 6 months prior to screening
Show all 31Show fewer
  • cladribine at any time.
  • Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
  • Patients with any of the following cardiovascular conditions :
  • history of myocardial infarction or with current unstable ischemic heart disease;
  • Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the Investigator (see Appendix 5);
  • history or presence of a second-degree AV block, Type II or a third-degree AV block
  • patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide);
  • proven history of sick sinus syndrome;
  • uncontrolled hypertension
  • Patients with severe respiratory disease, pulmonary fibrosis, or chronic obstructive pulmonary disease (Class III-IV).
  • Patients with history of specific MRI findings (tumor, subdural haematoma, post-contusional changes, territorial stroke, neurodegenerative disorders, aneurysm/arteriovenous malformation, evidence of past macroscopic haemorrhage, or other relevant MRI findings that would interfere with evaluation)
  • Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  • Patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives of screening, whichever is longer.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test (serum)
  • Patients with any ophthalmologic reason for RNFL pathology other than MS, such as: optic neuropathy, active advanced glaucoma, injury of the optic nerve based on the ophthalmologist's clinical judgment
  • history or presence of severe myopia
  • in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters
  • pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma
  • in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm
  • Acute optic neuritis within the past 6 months before screening
  • Evidence of advanced, non-proliferative or proliferative diabetic retinopathy
  • Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
  • Concomitant use of drugs that may directly affect retinal structure and function (e.g.
  • chronic systemic corticosteroids [>30 consecutive days; doses higher than Cushing threshold e.g. prednisone 7.5mg/d], intraocular anti-angiogenic drugs [ranibizumab, bevacizumab], intraocular steroids etc.)

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Germany9 sites

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

Switzerland1 site

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya®

This was a 3-year, prospective, multi-center, open-label study to describe the long term changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment with Fingolimod. It was designed to longitudinally study the degeneration of retinal axons by measuring change in RNFL thickness by latest OCT-technology.

Being tested
Fingolimod
Keywords
Multiple sclerosis (MS), MS
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FingolimodDrug

    Also called FTY720

    All subjects received an oral dose of 0.5 mg fingolimod (FTY720) per capsule (hard gelatin capsules) once daily according to local label for the treatment of their MS.

Study groups in NCT01705236
Study groupRoleWhat they receive
Fingolimod - Longitudinal AssessmentExperimentalNo study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod had to be made independent of this study.
Receives: Drug: Fingolimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)

    The primary endpoint was the change, i.e. the absolute difference, in average RNFL thickness from baseline to month 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT).

    Measured: Baseline, month 36

Secondary outcomes (5)

  1. Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)

    Change from baseline in average RNFL thickness to months 12 and 24 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT).

    Measured: Baseline, month 12, month 24

  2. Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT)

    Change from baseline in average quadrant RNFL thickness to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average quadrant RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT). Quadrant RNFL thickness were: Nasal-inferior; nasal-superior; temporal-inferior; temporal-superior.

    Measured: Baseline, month 12, month 24, month 36

  3. Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV)

    Change from baseline in TMV to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS).

    Measured: 12, 24 and 36 months

  4. Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP)

    Change from baseline in GCIP to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS).

    The change in Ganglion cell layer thickness (GCLT) had been defined as secondary endpoint in the protocol, but OCT measured the GCIP instead. This was done because both layers were not clearly separable by OCT. GCIP was calculated as mean of the inner sectors (nasal, superior, temporal, and inferior) and declared as usual parameter instead. This change was introduced prior to data base lock, but the derivation of GCIP was corrected after data base lock.

    Measured: Baseline, month 12, month 24, month 36

  5. Number of Participants With Adverse Events

    Number of participants with adverse events and specifically macular edema.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study start20 Aug 2012
  3. Primary completion18 Feb 2019
  4. Study completion18 Feb 2019

Resources

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 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705236
Sponsor's protocol ID
CFTY720DDE15TS
Acronym
PASSOS
Status last verified
Feb 2020
First submitted
13 Aug 2012
Last updated
2 Mar 2020
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod in people with Relapsing Remitting Multiple Sclerosis RRMS, run by Novartis Pharmaceuticals at 10 sites in 2 countries.

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 8 inclusion and 31 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Switzerland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) (time frame: Baseline, month 36). 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 NCT01705236.

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 2 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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