MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

NCT01633112 | Terminated Phase 3 Results DMC

• 1 other identifier: CFTY720D2312
• Study Type: interventional
• Target: 1,064
• Locations: 7 countries
• Sites: 130

Brief Summary

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

• Confirmed Annualized Relapse Rate

  Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.

  up to 12 months

Secondary Outcomes (8)

• New or Newly Enlarging T2 Lesions

  At 12 months/end of study

• Number of Participants Free of New/Newly Enlarged T2 Lesions

  At 12 months/end of study

• Change From Baseline in T2 Lesion Volume

  Baseline, 12 months/end of study

• Gd Enhancing T1 Lesion Count

  At 12 months/end of study

• Gd Enhancing T1 Lesion Volume

  Baseline, 12 months/end of study

Study Arms (3)

fingolimod 0.5 mg

EXPERIMENTAL

orally once daily

Drug: fingolimod

fingolimod 0.25mg

EXPERIMENTAL

orally once daily

Drug: fingolimod

glatiramer acetate 20 mg

ACTIVE COMPARATOR

subcutaneous once daily

Drug: glatiramer acetate

Interventions

fingolimod DRUG

capsule

Also known as: FTY720, fingolimod hydrochloride,, Gilenya

fingolimod 0.25mg; fingolimod 0.5 mg

glatiramer acetate DRUG

subcutaneous injection

Also known as: Copaxone, Glatopa

glatiramer acetate 20 mg

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 and female patients 18 to 65 years of age, inclusive.
• Patients with RRMS, as defined by 2010 revised McDonald criteria.
• Patients must be neurologically stable with no onset of relapse within 30 days of randomization
• Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.
• Patients with an EDSS score of 0 to 6, inclusive, at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting.

You may not qualify if:

• Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma) in the last 5 years that do not have confirmation of absence of a malignancy prior to randomization
• Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).
• Patients who have been treated with:
• High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization
• Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
• Natalizumab within 2 months before randomization
• Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization
• Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization.
• No washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate.
• Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period).
• Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure.
• Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin \>9%) or with diabetic neuropathy.
• Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening).
• Patients with severe active bacterial, viral, or fungal infections.
• Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (130)

Novartis Investigative Site

Cullman, Alabama, 35058, United States

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Phoenix, Arizona, 85004, United States

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Phoenix, Arizona, 85013, United States

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Phoenix, Arizona, 85018, United States

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Tucson, Arizona, 85741, United States

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Los Angeles, California, 90089, United States

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Sacramento, California, 95817, United States

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Aurora, Colorado, 80045, United States

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Boulder, Colorado, 80304, United States

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Denver, Colorado, 80220, United States

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Fort Collins, Colorado, 80528, United States

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Loveland, Colorado, 80538, United States

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Fairfield, Connecticut, 06824, United States

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Newark, Delaware, 19713, United States

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Washington D.C., District of Columbia, 20007, United States

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Jacksonville, Florida, 32209, United States

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Maitland, Florida, 32751, United States

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Naples, Florida, 34119, United States

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New Port Richey, Florida, 34653, United States

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Orlando, Florida, 32806, United States

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Ormond Beach, Florida, 32174, United States

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Pompano Beach, Florida, 33060, United States

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Ponte Vedra Beach, Florida, 32082-4627, United States

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Port Charlotte, Florida, 33952, United States

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Sarasota, Florida, 34243, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33609, United States

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Vero Beach, Florida, 32960, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30327, United States

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Elk Grove Village, Illinois, 60007, United States

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Evanston, Illinois, 60201, United States

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Flossmoor, Illinois, 60422, United States

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Northbrook, Illinois, 60062, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46256, United States

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West Des Moines, Iowa, 50314, United States

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Kansas City, Kansas, 66160, United States

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Lenexa, Kansas, 66212, United States

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Louisville, Kentucky, 40207, United States

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Hammond, Louisiana, 70403, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02215, United States

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Springfield, Massachusetts, 01104, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Farmington Hills, Michigan, 48334, United States

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Grand Rapids, Michigan, 49503, United States

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Traverse City, Michigan, 49684-2340, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63131, United States

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St Louis, Missouri, 63141, United States

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Great Falls, Montana, 59405, United States

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Las Vegas, Nevada, 89106, United States

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Freehold, New Jersey, 07728, United States

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Newark, New Jersey, 07103, United States

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Teaneck, New Jersey, 07666, United States

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Albuquerque, New Mexico, 87131, 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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Buffalo, New York, 14203, United States

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Patchogue, New York, 11772, United States

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Rochester, New York, 14642, United States

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Stony Brook, New York, 11794, United States

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Syracuse, New York, 13210, United States

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Chapel Hill, North Carolina, 27599-9500, United States

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Charlotte, North Carolina, 28204, United States

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Winston-Salem, North Carolina, 27157, United States

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Akron, Ohio, 44320, United States

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Bellevue, Ohio, 44811, United States

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Columbus, Ohio, 43210, 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, 43614, 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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Tulsa, Oklahoma, 74137, United States

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Portland, Oregon, 97225, United States

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Philadelphia, Pennsylvania, 19141, United States

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Spartanburg, South Carolina, 29302, United States

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Cordova, Tennessee, 38018, United States

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Knoxville, Tennessee, 37934, United States

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Nashville, Tennessee, 37204, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75214, United States

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Houston, Texas, 77030, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78258, United States

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Sherman, Texas, 75092, United States

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Salt Lake City, Utah, 84103, United States

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Alexandria, Virginia, 22310, United States

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Charlottesville, Virginia, 22903, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23226, United States

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Roanoke, Virginia, 24018, United States

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Issaquah, Washington, 98029, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98122-4379, United States

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Milwaukee, Wisconsin, 53215, United States

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CABA, Buenos Aires, C1437JCP, Argentina

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Buenos Aires, C1015ABR, Argentina

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Belo Horizonte, Minas Gerais, 30150 221, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Joinville, Santa Catarina, 89202-165, Brazil

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São Paulo, São Paulo, 08270-070, Brazil

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Campina Grande do Sul, 83430 000, Brazil

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Goiânia, 74605 020, Brazil

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Passo Fundo, 99010-080, Brazil

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Rio de Janeiro, 22610-350, Brazil

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São Paulo, 05651-901, Brazil

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Edmonton, Alberta, T6R 2B7, Canada

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Burnaby, British Columbia, V5G 2X6, Canada

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Halifax, Nova Scotia, B3H 4K4, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Santiago, 8380815, Chile

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Santiago, PISO 1, Chile

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Tlalnepantla, Edo de Mexico, 54055, Mexico

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Mexico City, Mexico City, 03310, Mexico

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Monterrey, Nuevo León, 64000, Mexico

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San Luis Potosí City, San Luis Potosí, 78240, Mexico

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Aguascalientes, 20127, Mexico

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Chihuahua City, 31000, Mexico

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Chihuahua City, 31203, Mexico

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Monterrey, 64460, Mexico

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Guaynabo, 00968, Puerto Rico

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Related Publications (1)

• Cree BAC, Goldman MD, Corboy JR, Singer BA, Fox EJ, Arnold DL, Ford C, Weinstock-Guttman B, Bar-Or A, Mientus S, Sienkiewicz D, Zhang Y, Karan R, Tenenbaum N; ASSESS Trial Investigators. Efficacy and Safety of 2 Fingolimod Doses vs Glatiramer Acetate for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2020 Aug 24;78(1):1-13. doi: 10.1001/jamaneurol.2020.2950. Online ahead of print.

  PMID: 32852530 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride; Glatiramer Acetate; Coat Protein Complex I

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; Peptides; Amino Acids, Peptides, and Proteins; Vesicular Transport Proteins; Membrane Proteins; Proteins

Limitations and Caveats

Terminated due to slow recruitment.

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Fingolimod patients were dose blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 4, 2012
• Study Start: August 9, 2012
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

CL (2); ME (8); PR (1); US (101); AR (2); BR (9); CA (7)