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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 September 2020
Main ID:  EUCTR2012-000674-31-DE
Date of registration: 27/04/2012
Prospective Registration: Yes
Primary sponsor: Novartis Pharma GmbH
Public 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®
Scientific 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®
Date of first enrolment: 01/08/2012
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000674-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Germany Switzerland
Contacts
Name: Project Leader   
Address:  Roonstr. 25 90429 Nürnberg Germany
Telephone: 004991127313187
Email: francisca.blumhagen@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Project Leader   
Address:  Roonstr. 25 90429 Nürnberg Germany
Telephone: 004991127313187
Email: francisca.blumhagen@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion criteria
Inclusion 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 (visit 2)
7. Sufficient ability to read, write, communicate and understand

* one month is defined as 28 days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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
a. in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters
b. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma
c. 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.)

* one month is defined as 28 days


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
RNFLT in Patients with relapsing remitting Multiple Sclerosis
MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: Fingolimod Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)
Main Objective: To evaluate the change in average RNFL thickness (RNFLT) in RRMS patients treated with fingolimod over 36 months as assessed by OCT.
Primary end point(s): To evaluate the change in average RNFL thickness (RNFLT) in RRMS patients treated with fingolimod over 36 months as assessed by OCT.
Secondary Objective: To evaluate the change in average RNFLT under fingolimod therapy from baseline to months 12 and 24 as assessed by OCT.
To evaluate change in quadrant RNFLT under fingolimod therapy from baseline to months 12, 24 and 36
To evaluate changes in total macular volume (TMV) under fingolimod therapy from baseline to months 12, 24 and 36.
To evaluate changes in ganglion cell layer thickness (GCLT) under fingolimod therapy from baseline to months 12, 24 and 36.
To compare changes in OCT parameters between eyes with and without history of optic neuritis and between right and left eye.
To evaluate 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.
Timepoint(s) of evaluation of this end point: after 3 years
Secondary Outcome(s)
Secondary end point(s): To evaluate the change in average RNFLT under fingolimod therapy from baseline to months 12 and 24 as assessed by OCT.
To evaluate change in quadrant RNFLT under fingolimod therapy from baseline to months 12, 24 and 36
To evaluate changes in total macular volume (TMV) under fingolimod therapy from baseline to months 12, 24 and 36.
To evaluate changes in ganglion cell layer thickness (GCLT) under fingolimod therapy from baseline to months 12, 24 and 36.
To compare changes in OCT parameters between eyes with and without history of optic neuritis and between right and left eye.
To evaluate 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.
Timepoint(s) of evaluation of this end point: every year
Secondary ID(s)
CFTY720DDE15TS
Source(s) of Monetary Support
Novartis Pharma GmbH
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 01/08/2012
Contact:
Results
Results available: Yes
Date Posted: 01/03/2020
Date Completed: 18/02/2019
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-000674-31/results
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