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

NCT01705236 | Completed Phase 4 Results

• 1 other identifier: CFTY720DDE15TS
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 10

Brief 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. It was designed to longitudinally study the degeneration of retinal axons by measuring change in RNFL thickness by latest OCT-technology.

Conditions

Relapsing Remitting Multiple Sclerosis RRMS

Keywords

Multiple sclerosis (MS); MS

Outcome Measures

Primary Outcomes (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).

  Baseline, month 36

Secondary Outcomes (5)

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

  Baseline, month 12, month 24

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

  Baseline, month 12, month 24, month 36

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

  12, 24 and 36 months

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

  Baseline, month 12, month 24, month 36

• Number of Participants With Adverse Events

  36 months

Study Arms (1)

Fingolimod - Longitudinal Assessment

EXPERIMENTAL

No 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.

Drug: Fingolimod

Interventions

Fingolimod DRUG

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.

Also known as: FTY720

Fingolimod - Longitudinal Assessment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Sufficient ability to read, write, communicate and understand

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Rostock, 18057, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: October 12, 2012
• Study Start: August 20, 2012
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: March 2, 2020
• Results First Posted: March 2, 2020

Record last verified: 2020-02

Locations

DE (9); CH (1)