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

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ClinicalTrials.gov Identifier: NCT01705236
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is 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 is designed to longitudinally study the degeneration of retinal axons by measuring change in RNFL thickness by latest OCT-technology. Correlations of OCT findings with available MRI data and clinical findings may enhance our understanding of the relationship between CNS inflammation, tissue injury, regeneration and neurological deficit in the context of fingolimod therapy.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis RRMS Other: longitudinal assessment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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®
Actual Study Start Date : August 20, 2012
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : February 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
longitudinal assessment
additional OCT assessments
Other: longitudinal assessment
OTC assessments




Primary Outcome Measures :
  1. average Retinal Nerve Fiber Layer Thickness (RNFLT) [ Time Frame: 36 months ]
    To evaluate the change in average RNFLT in RRMS patients treated with fingolimod over 36 months as assessed by OCT


Secondary Outcome Measures :
  1. average Retinal Nerve Fiber Layer Thickness (RNFLT) [ Time Frame: 12 months and 24 months ]
    To evaluate the change in average RNFLT under fingolimod therapy from baseline to months 12 and 24 as asssessed by OCT

  2. quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) [ Time Frame: 12, 24 and 36 months ]
    To evaluate the change in quadrant RNFLT under fingolimod therapy from baseline to months 12, 24 and 36 as asssessed by OCT

  3. total macular volume (TMV) [ Time Frame: 12, 24 and 36 months ]
    To evaluate the change in TMV under fingolimod therapy from baseline to months 12, 24 and 36 as asssessed by OCT

  4. ganglion cell layer thickness (GCLT) [ Time Frame: 12, 24 and 36 months ]
    To evaluate the change in GCLT under fingolimod therapy from baseline to months 12, 24 and 36 as asssessed by OCT

  5. number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 36 months ]
    To evaluate the number of participants with adverse events as a measure of safety and tolerability of fingolimod in MS patients followed for up to 36 months and specifically to determine the frequency of macular edema under treatment with oral fingolimod in this patient population



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

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

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

  1. 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
    • cladribine at any time.
  2. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
  3. 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
  4. Patients with severe respiratory disease, pulmonary fibrosis, or chronic obstructive pulmonary disease (Class III-IV).
  5. 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)
  6. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator`s discretion
  7. 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
  8. Patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives of screening, whichever is longer.
  9. 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)
  10. 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
  11. history or presence of severe myopia

    1. in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters
    2. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma
    3. in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm
  12. Acute optic neuritis within the past 6 months before screening
  13. Evidence of advanced, non-proliferative or proliferative diabetic retinopathy
  14. Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
  15. 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.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705236


Locations
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Germany
Novartis Investigative Site
Bochum, Germany, 44791
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Rostock, Germany, 18057
Novartis Investigative Site
Ulm, Germany, 89081
Switzerland
Novartis Investigative Site
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01705236     History of Changes
Other Study ID Numbers: CFTY720DDE15TS
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs