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Relapsing-remitting Multiple Sclerosis (RRMS)Phase 3ASSESSNCT01633112

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

A Phase 3 study testing fingolimod and glatiramer acetate in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Novartis Pharmaceuticals at 130 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
fingolimod and glatiramer acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,064 participants
Where
130 sitesin 7 countries
Study dates
9 Aug 2012to 30 Apr 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.
  • Patients who have received any live or live-attenuated vaccines (including VZV, herpes simplex, or measles) within 1 month before randomization.
  • Patients who have received total lymphoid irradiation or bone marrow transplantation.
  • Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site.
  • Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure.

Trial locations and contacts

130 sites in 7 countries.

130 sites in 7 countries

United States101 sites

  • Novartis Investigative Site

    Akron, Ohio, 44320

  • Novartis Investigative Site

    Albany, New York, 12208

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87131

  • Novartis Investigative Site

    Alexandria, Virginia, 22310

  • Novartis Investigative Site

    Amherst, New York, 14226

  • Novartis Investigative Site

    Atlanta, Georgia, 30327

  • Novartis Investigative Site

    Aurora, Colorado, 80045

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Bellevue, Ohio, 44811

  • Novartis Investigative Site

    Boston, Massachusetts, 02215

  • Novartis Investigative Site

    Boulder, Colorado, 80304

  • Novartis Investigative Site

    Buffalo, New York, 14203

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599-9500

  • Novartis Investigative Site

    Charlotte, North Carolina, 28204

  • Novartis Investigative Site

    Charlottesville, Virginia, 22903

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Columbus, Ohio, 43221

  • Novartis Investigative Site

    Cordova, Tennessee, 38018

  • Novartis Investigative Site

    Cullman, Alabama, 35058

  • Novartis Investigative Site

    Dallas, Texas, 75214

  • Novartis Investigative Site

    Dayton, Ohio, 45408

  • Novartis Investigative Site

    Denver, Colorado, 80220

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Detroit, Michigan, 48202

  • Novartis Investigative Site

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Evanston, Illinois, 60201

  • Novartis Investigative Site

    Fairfield, Connecticut, 06824

  • Novartis Investigative Site

    Farmington Hills, Michigan, 48334

  • Novartis Investigative Site

    Flossmoor, Illinois, 60422

  • Novartis Investigative Site

    Fort Collins, Colorado, 80528

  • Novartis Investigative Site

    Freehold, New Jersey, 07728

  • Novartis Investigative Site

    Grand Rapids, Michigan, 49503

  • Novartis Investigative Site

    Great Falls, Montana, 59405

  • Novartis Investigative Site

    Hammond, Louisiana, 70403

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Issaquah, Washington, 98029

  • Novartis Investigative Site

    Jacksonville, Florida, 32209

  • Novartis Investigative Site

    Kansas City, Kansas, 66160

  • Novartis Investigative Site

    Kansas City, Missouri, 64111

  • Novartis Investigative Site

    Knoxville, Tennessee, 37934

  • Novartis Investigative Site

    Las Vegas, Nevada, 89106

  • Novartis Investigative Site

    Lenexa, Kansas, 66212

  • Novartis Investigative Site

    Los Angeles, California, 90089

  • Novartis Investigative Site

    Louisville, Kentucky, 40207

  • Novartis Investigative Site

    Loveland, Colorado, 80538

  • Novartis Investigative Site

    Maitland, Florida, 32751

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53215

  • Novartis Investigative Site

    Naples, Florida, 34119

  • Novartis Investigative Site

    Nashville, Tennessee, 37204

  • Novartis Investigative Site

    Nashville, Tennessee, 37205

  • Novartis Investigative Site

    New Orleans, Louisiana, 70121

  • Novartis Investigative Site

    New Port Richey, Florida, 34653

  • Novartis Investigative Site

    Newark, Delaware, 19713

  • Novartis Investigative Site

    Newark, New Jersey, 07103

  • Novartis Investigative Site

    Norfolk, Virginia, 23507

  • Novartis Investigative Site

    Northbrook, Illinois, 60062

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73104

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Ormond Beach, Florida, 32174

  • Novartis Investigative Site

    Patchogue, New York, 11772

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19141

  • Novartis Investigative Site

    Phoenix, Arizona, 85004

  • Novartis Investigative Site

    Phoenix, Arizona, 85013

  • Novartis Investigative Site

    Phoenix, Arizona, 85018

  • Novartis Investigative Site

    Pompano Beach, Florida, 33060

  • Novartis Investigative Site

    Ponte Vedra Beach, Florida, 32082-4627

  • Novartis Investigative Site

    Port Charlotte, Florida, 33952

  • Novartis Investigative Site

    Portland, Oregon, 97225

  • Novartis Investigative Site

    Richmond, Virginia, 23226

  • Novartis Investigative Site

    Roanoke, Virginia, 24018

  • Novartis Investigative Site

    Rochester, New York, 14642

  • Novartis Investigative Site

    Round Rock, Texas, 78681

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    Salt Lake City, Utah, 84103

  • Novartis Investigative Site

    San Antonio, Texas, 78258

  • Novartis Investigative Site

    Sarasota, Florida, 34243

  • Novartis Investigative Site

    Seattle, Washington, 98101

  • Novartis Investigative Site

    Seattle, Washington, 98122-4379

  • Novartis Investigative Site

    Sherman, Texas, 75092

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29302

  • Novartis Investigative Site

    Springfield, Massachusetts, 01104

  • Novartis Investigative Site

    St Louis, Missouri, 63104

  • Novartis Investigative Site

    St Louis, Missouri, 63131

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Stony Brook, New York, 11794

  • Novartis Investigative Site

    Syracuse, New York, 13210

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tampa, Florida, 33609

  • Novartis Investigative Site

    Teaneck, New Jersey, 07666

  • Novartis Investigative Site

    Toledo, Ohio, 43614

  • Novartis Investigative Site

    Traverse City, Michigan, 49684-2340

  • Novartis Investigative Site

    Tucson, Arizona, 85741

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74137

  • Novartis Investigative Site

    Vero Beach, Florida, 32960

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

  • Novartis Investigative Site

    West Des Moines, Iowa, 50314

  • Novartis Investigative Site

    West Palm Beach, Florida, 33407

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Brazil9 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150 221

  • Novartis Investigative Site

    Campina Grande do Sul, 83430 000

  • Novartis Investigative Site

    Goiânia, 74605 020

  • Novartis Investigative Site

    Joinville, Santa Catarina, 89202-165

  • Novartis Investigative Site

    Passo Fundo, 99010-080

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Rio de Janeiro, 22610-350

  • Novartis Investigative Site

    São Paulo, São Paulo, 08270-070

  • Novartis Investigative Site

    São Paulo, 05651-901

Other trials in Brazil

Mexico8 sites

  • Novartis Investigative Site

    Aguascalientes, 20127

  • Novartis Investigative Site

    Chihuahua City, 31000

  • Novartis Investigative Site

    Chihuahua City, 31203

  • Novartis Investigative Site

    Mexico City, Mexico City, 03310

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64000

  • Novartis Investigative Site

    Monterrey, 64460

  • Novartis Investigative Site

    San Luis Potosí City, San Luis Potosí, 78240

  • Novartis Investigative Site

    Tlalnepantla, Edo de Mexico, 54055

Other trials in Mexico

Canada7 sites

  • Novartis Investigative Site

    Burnaby, British Columbia, V5G 2X6

  • Novartis Investigative Site

    Chicoutimi, Quebec, G7H 5H6

  • Novartis Investigative Site

    Edmonton, Alberta, T6R 2B7

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 4K4

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Montreal, Quebec, H3A 2B4

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Argentina2 sites

  • Novartis Investigative Site

    Buenos Aires, C1015ABR

  • Novartis Investigative Site

    CABA, Buenos Aires, C1437JCP

Other trials in Argentina

Chile2 sites

  • Novartis Investigative Site

    Santiago, 8380815

  • Novartis Investigative Site

    Santiago, PISO 1

Other trials in Chile

Puerto Rico1 site

  • Novartis Investigative Site

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

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

Read the detailed description

This was a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS.

This study consisted of 3 periods:

  • Screening Period: up to 45 days for all patients
  • Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
  • Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).

Treatment groups:

  • fingolimod 0.5 mg/day orally for up to 12 months
  • fingolimod 0.25 mg/day orally for up to 12 months
  • glatiramer acetate 20 mg/day subcutaneously for up to 12 months
Being tested
fingolimod, glatiramer acetate
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fingolimodDrug

    Also called FTY720, fingolimod hydrochloride,, Gilenya

    capsule

  • glatiramer acetateDrug

    Also called Copaxone, Glatopa

    subcutaneous injection

Study groups in NCT01633112
Study groupRoleWhat they receive
fingolimod 0.5 mgExperimentalorally once daily
Receives: Drug: fingolimod
fingolimod 0.25mgExperimentalorally once daily
Receives: Drug: fingolimod
glatiramer acetate 20 mgActive comparatorsubcutaneous once daily
Receives: Drug: glatiramer acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 12 months

Secondary outcomes (8)

  1. New or Newly Enlarging T2 Lesions

    Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.

    Measured: At 12 months/end of study

  2. Number of Participants Free of New/Newly Enlarged T2 Lesions

    Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.

    Measured: At 12 months/end of study

  3. Change From Baseline in T2 Lesion Volume

    Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume

    Measured: Baseline, 12 months/end of study

  4. Gd Enhancing T1 Lesion Count

    Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count

    Measured: At 12 months/end of study

  5. Gd Enhancing T1 Lesion Volume

    Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count

    Measured: Baseline, 12 months/end of study

  6. Percentage of Patients Free of New T1 Hypointense Lesions

    Based on MRI measures of new T1 hypointense lesions

    Measured: 12 months

  7. Change From Baseline in TSQM Scales

    Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.

    Measured: 6 months, 12 months/end of study

  8. Percent Brain Volume Change From Baseline

    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

    Measured: Baseline, 12 months, end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study start9 Aug 2012
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Why it stopped: slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,064 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633112
Sponsor's protocol ID
CFTY720D2312
Acronym
ASSESS
Status last verified
Apr 2019
First submitted
29 Jun 2012
Last updated
28 May 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • 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.

    PubMed 32852530

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fingolimod and glatiramer acetate in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Novartis Pharmaceuticals at 130 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Brazil, Mexico, Canada, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Annualized Relapse Rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01633112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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