Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

NCT01623596 | Completed Phase 4 Results

• 1 other identifier: CFTY720DUS09
• Study Type: interventional
• Target: 881
• Locations: 2 countries
• Sites: 123

Brief Summary

A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Participant Retention Rate Over 12 Months

  Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)

  at 12 months

Secondary Outcomes (5)

• Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set

  at 12 months

• Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)

  baseline, 6 months, 12 months, and Last assessment which is either at Month 12 or at early discontinuation

• Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)

  baseline, 6 months, 12 months, Last assessment which is either at Month 12 or at early discontinuation

• Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)

  12 months, and Last assessment which is either at Month 12 or at early discontinuation

• Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score

  Baseline, 1 month, 3 months, 6 months, 9 months, at 12 months & Last assessment during randomized phase which is either at Month 12 or at early discontinuation

Study Arms (2)

Fingolimod

EXPERIMENTAL

Drug: Fingolimod

Disease Modifying Therapy

ACTIVE COMPARATOR

2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)

Drug: Disease Modifying therapy

Interventions

Fingolimod DRUG

Fingolimod

Disease Modifying therapy DRUG

Disease Modifying Therapy

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 prior to any assessment being performed.
• Male and female patients aged 18-65 years inclusive.
• Patients diagnosed with relapsing remitting MS, defined by the 2010 revised McDonald criteria (Pollman et al, 2011) (Appendix 1).
• EDSS score of less than or equal to 6.
• Patients naive to treatment or who have been treated with no more than one class of DMT previously (interferon β preparation or glatiramer acetate), and who, per investigator judgment, may benefit from a change of treatment class.
• Patients who have been treated with DMF for less than 2 months total exposure and who have a normal lymphocyte count at screening.
• Women of childbearing potential must have a negative urine and serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and at baseline.
• Before entry women must be:
• Post menopausal for at least 1 year, or
• Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise incapable of pregnancy, or
• Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study, or

You may not qualify if:

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• Use of other investigational drugs within 30 days of screening.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Prior exposure to fingolimod or any other S1P receptor modulating compounds.
• History or presence of malignancy of any organ system (other than successfully treated basal or squamous cell carcinoma of the skin or stage 0 carcinoma of the cervix), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Patients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Primary Progressive MS (PPMS).
• Patients with a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
• Patients who have been treated with:
• Natalizumab, mitoxantrone, cladribine, rituximab, alemtuzumab, ofatumumab, ocrelizumab at any time before randomization
• Immunoglobulins, or pulse of corticosteroids with more than 6 months cumulative exposure
• Immunosuppressive/chemotherapeutic medications (e.g., methotrexate, azathioprine, cyclophosphamide, cellcept, Cytoxan, IVIG) with more than 6 months of cumulative exposure and within 6 months prior to randomization
• Corticosteroids or adrenocorticotropic hormones in the past 30 days before randomization. Patients that require corticosteroids for a relapse during the screening period may be rescreened 30 days after the last dose.
• History of treatment with both classes of approved first line DMT (interferon β preparation and glatiramer acetate) or DMF exposure of 2 months or longer.
• Patients with uncontrolled diabetes mellitus (HbA1c \> 7%).
• Diagnosis of macular edema during the screening phase. Patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the screening visit.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (123)

Novartis Investigative Site

Cullman, Alabama, 35058, United States

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Phoenix, Arizona, 85004, United States

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Sun City, Arizona, 85351, United States

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Tucson, Arizona, 85741, United States

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Sherwood, Arkansas, 72120, United States

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Fullerton, California, 92835, United States

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Oceanside, California, 92056, United States

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San Francisco, California, 94117, United States

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Walnut Creek, California, 94598, United States

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Basalt, Colorado, 81621, United States

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Boulder, Colorado, 80301, United States

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Denver, Colorado, 80209, United States

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Denver, Colorado, 80210, United States

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Fort Collins, Colorado, 80528, United States

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Fairfield, Connecticut, 06824, United States

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New London, Connecticut, 06320, United States

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Dover, Delaware, 19901, United States

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Atlantis, Florida, 33462-6608, United States

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Bradenton, Florida, 34205, United States

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Delray Beach, Florida, 33445, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32216, United States

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North Palm Beach, Florida, 33408, United States

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Plantation, Florida, 33324, United States

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Pompano Beach, Florida, 33060, United States

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Port Charlotte, Florida, 33952, United States

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Port Orange, Florida, 32127, United States

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Sarasota, Florida, 34233, United States

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Sarasota, Florida, 34243, United States

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St. Petersburg, Florida, 33713, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33609, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30312, United States

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Columbus, Georgia, 31904, United States

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Decatur, Georgia, 30083, United States

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Suwanee, Georgia, 30024, United States

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Flossmoor, Illinois, 60422, United States

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Northbrook, Illinois, 60062, United States

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Anderson, Indiana, 46011, United States

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Indianapolis, Indiana, 46227, United States

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Indianapolis, Indiana, 46256, United States

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Des Moines, Iowa, 50314-2611, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, 67214, United States

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Hawesville, Kentucky, 42384, United States

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Lexington, Kentucky, 40504, United States

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Madisonville, Kentucky, 42431, United States

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Alexandria, Louisiana, 71301, United States

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Baton Rouge, Louisiana, 70809, United States

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New Orleans, Louisiana, 70115, United States

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Annapolis, Maryland, 21401, United States

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Fulton, Maryland, 20759, United States

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New Bedford, Massachusetts, 02740, United States

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North Dartmouth, Massachusetts, 02747, United States

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Springfield, Massachusetts, 01104, United States

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Watertown, Massachusetts, 02472, United States

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Worcester, Massachusetts, 01608, United States

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Kalamazoo, Michigan, 49007, United States

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Traverse City, Michigan, 49684-2340, United States

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Nixa, Missouri, 65714-7807, United States

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North Kansas City, Missouri, 64116, United States

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St Louis, Missouri, 63104, United States

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Las Vegas, Nevada, 89121, United States

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Las Vegas, Nevada, 89123, United States

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Las Vegas, Nevada, 89144, United States

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Flemington, New Jersey, 08822, United States

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Teaneck, New Jersey, 07666, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87108, United States

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Albany, New York, 12208, United States

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Amherst, New York, 14226, United States

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Kingston, New York, 12401, United States

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Latham, New York, 12110, United States

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New York, New York, 10003, United States

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Patchogue, New York, 11772, United States

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The Bronx, New York, 10467-2490, United States

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Asheville, North Carolina, 28806, United States

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Charlotte, North Carolina, 28202, United States

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Charlotte, North Carolina, 28204, United States

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Greensboro, North Carolina, 27401, United States

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Greenville, North Carolina, 27834, United States

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Raleigh, North Carolina, 27607, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Grand Forks, North Dakota, 58201, United States

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Akron, Ohio, 44320, United States

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Bellevue, Ohio, 44811, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43221, United States

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Dayton, Ohio, 45408, United States

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Toledo, Ohio, 43623, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73112, United States

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Eugene, Oregon, 97401, United States

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Greensburg, Pennsylvania, 15601, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Cranston, Rhode Island, 02920, United States

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Old Point Station, South Carolina, 29707, United States

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Spartanburg, South Carolina, 29302, United States

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Spartanburg, South Carolina, 29307, United States

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Cordova, Tennessee, 38018, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37205, United States

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Colleyville, Texas, 76034, United States

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Houston, Texas, 77074, United States

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Lubbock, Texas, 79410, United States

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North Richland Hills, Texas, 76180, United States

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Plano, Texas, 75075, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78229, United States

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Orem, Utah, 84058, United States

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Alexandria, Virginia, 22310, United States

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Norfolk, Virginia, 23507, United States

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Vienna, Virginia, 22182, United States

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Bothell, Washington, 98011, United States

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Seattle, Washington, 98101, United States

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Tacoma, Washington, 98405, United States

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Morgantown, West Virginia, 26506-9260, United States

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Neenah, Wisconsin, 54956, United States

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Guaynabo, 00968, Puerto Rico

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Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Multiple Sclerosis; 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

(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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: June 8, 2012
• Primary Completion: July 13, 2015
• Study Completion: July 13, 2015
• Last Updated: January 5, 2021
• Results First Posted: January 12, 2018

Record last verified: 2019-03

Locations

US (122); PR (1)