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Relapsing Remitting Multiple SclerosisPhase 4PREFERMSNCT01623596

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

A Phase 4 study testing Fingolimod and Disease Modifying therapy in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 123 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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) . Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsing Remitting Multiple Sclerosis
What is being tested?
Fingolimod and Disease Modifying therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
881 participants
Where
123 sitesin 2 countries
Study dates
8 Jun 2012to 13 Jul 2015
Phase
Phase 4
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 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.
Show all 62Show fewer
  • 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
  • Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) 4.2 Exclusion criteria
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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.
  • Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
  • Patients without history of chickenpox or without vaccination against varicella-zoster virus at screening (patients may be vaccinated and rescreened one month or longer after vaccination).
  • Patients who have received any live or live attenuated vaccines (including for varicella-zoster or measles) within 1 month prior to baseline.
  • Patients with any medically unstable condition as assessed by the investigator.
  • Patients with a history of the following cardiovascular conditions:
  • Cardiac arrest.
  • myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure (Appendix 3).
  • Congestive heart failure.
  • Hypertension that is not controlled with prescribed medications. These patients may be rescreened if blood pressure is stabilized with treatment.
  • Cerebrovascular disease.
  • History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker.
  • Patients at higher risk of symptomatic bradycardia or heart block because of a coexisting medical condition or certain concomitant medications.
  • Patients randomized to the fingolimod arm with prolonged QTc interval at screening (corrected QT interval > 450 ms in males and > 470 ms in females); for patients randomized to the fingolimod treatment arm before dosing (baseline) or during the 6-hour observation period; and those patients at additional risk for QT prolongation (e.g., hypokalemia, hypomagnesemia, congenital long-QT syndrome), or on a concomitant therapy with QT prolonging drugs with a known risk of Torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin).
  • Patients receiving class Ia or Class III antiarrhythmic drugs (Appendix 6)
  • Patients receiving concurrent therapy with drugs that slow the heart rate or atrioventricular conduction (e.g., beta blockers, digoxin, or heart-rate slowing calcium channel blockers such as diltiazem, verapamil or digoxin). The possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction should be evaluated by the physician prescribing these drugs before initiating fingolimod treatment.
  • History of sick sinus syndrome or sinoatrial heart block.
  • Resting heart rate of < 45 bpm or symptomatic bradycardia
  • Recurrent syncope
  • Severe untreated sleep apnea
  • Patients with severe pulmonary conditions (including severe respiratory disease, pulmonary fibrosis, active tuberculosis, severe or poorly controlled asthma).
  • Patients with any of the following hepatic conditions:
  • Chronic liver or biliary disease
  • Total bilirubin greater than upper limit of normal (ULN) at screening unless in the context of Gilbert's syndrome
  • Conjugated bilirubin greater than the ULN at screening
  • AST (SGOT), ALT (SGPT) greater than 3 times ULN at screening
  • Alkaline phosphatase (AP) greater than 1.5 times the ULN at screening
  • Serum creatinine greater than 2.0 mg/dL (176.5 µmol/L) at screening.
  • Patients with the following neurological/psychiatric disorders:
  • History of substance abuse (drug or alcohol) in the past five years as determined by the investigator
  • Progressive neurological disorder other than MS which may affect study participation as determined by the investigator
  • Any serious psychiatric condition that may interfere with the patient's ability to cooperate and comply with the study procedures as determined by the investigator
  • Women who are pregnant or nursing (lactating) or planning to become pregnant.
  • Any condition that in the opinion of the investigator, would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
  • Pre-planned surgery or medical procedure that would interfere with the conduct of the study.
  • Employee of the sponsor, investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Who cannot join

None listed.

Trial locations and contacts

123 sites in 2 countries.

123 sites in 2 countries

United States122 sites

  • Novartis Investigative Site

    Akron, Ohio, 44320

  • Novartis Investigative Site

    Albany, New York, 12208

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87108

  • Novartis Investigative Site

    Alexandria, Louisiana, 71301

  • Novartis Investigative Site

    Alexandria, Virginia, 22310

  • Novartis Investigative Site

    Amherst, New York, 14226

  • Novartis Investigative Site

    Anderson, Indiana, 46011

  • Novartis Investigative Site

    Annapolis, Maryland, 21401

  • Novartis Investigative Site

    Asheville, North Carolina, 28806

  • Novartis Investigative Site

    Atlanta, Georgia, 30312

  • Novartis Investigative Site

    Atlantis, Florida, 33462-6608

  • Novartis Investigative Site

    Basalt, Colorado, 81621

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70809

  • Novartis Investigative Site

    Bellevue, Ohio, 44811

  • Novartis Investigative Site

    Bothell, Washington, 98011

  • Novartis Investigative Site

    Boulder, Colorado, 80301

  • Novartis Investigative Site

    Bradenton, Florida, 34205

  • Novartis Investigative Site

    Canton, Ohio, 44718

  • Novartis Investigative Site

    Charlotte, North Carolina, 28202

  • Novartis Investigative Site

    Charlotte, North Carolina, 28204

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219

  • Novartis Investigative Site

    Colleyville, Texas, 76034

  • Novartis Investigative Site

    Columbus, Georgia, 31904

  • Novartis Investigative Site

    Columbus, Ohio, 43221

  • Novartis Investigative Site

    Cordova, Tennessee, 38018

  • Novartis Investigative Site

    Cranston, Rhode Island, 02920

  • Novartis Investigative Site

    Cullman, Alabama, 35058

  • Novartis Investigative Site

    Dayton, Ohio, 45408

  • Novartis Investigative Site

    Decatur, Georgia, 30083

  • Novartis Investigative Site

    Delray Beach, Florida, 33445

  • Novartis Investigative Site

    Denver, Colorado, 80209

  • Novartis Investigative Site

    Denver, Colorado, 80210

  • Novartis Investigative Site

    Des Moines, Iowa, 50314-2611

  • Novartis Investigative Site

    Dover, Delaware, 19901

  • Novartis Investigative Site

    Eugene, Oregon, 97401

  • Novartis Investigative Site

    Fairfield, Connecticut, 06824

  • Novartis Investigative Site

    Flemington, New Jersey, 08822

  • Novartis Investigative Site

    Flossmoor, Illinois, 60422

  • Novartis Investigative Site

    Fort Collins, Colorado, 80528

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Fulton, Maryland, 20759

  • Novartis Investigative Site

    Grand Forks, North Dakota, 58201

  • Novartis Investigative Site

    Greensboro, North Carolina, 27401

  • Novartis Investigative Site

    Greensburg, Pennsylvania, 15601

  • Novartis Investigative Site

    Greenville, North Carolina, 27834

  • Novartis Investigative Site

    Hawesville, Kentucky, 42384

  • Novartis Investigative Site

    Hershey, Pennsylvania, 17033-0850

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Houston, Texas, 77074

  • Novartis Investigative Site

    Indianapolis, Indiana, 46227

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Jacksonville, Florida, 32216

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49007

  • Novartis Investigative Site

    Kingston, New York, 12401

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

  • Novartis Investigative Site

    Las Vegas, Nevada, 89121

  • Novartis Investigative Site

    Las Vegas, Nevada, 89123

  • Novartis Investigative Site

    Las Vegas, Nevada, 89144

  • Novartis Investigative Site

    Latham, New York, 12110

  • Novartis Investigative Site

    Lexington, Kentucky, 40504

  • Novartis Investigative Site

    Lubbock, Texas, 79410

  • Novartis Investigative Site

    Madisonville, Kentucky, 42431

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506-9260

  • Novartis Investigative Site

    Nashville, Tennessee, 37205

  • Novartis Investigative Site

    Neenah, Wisconsin, 54956

  • Novartis Investigative Site

    New Bedford, Massachusetts, 02740

  • Novartis Investigative Site

    New London, Connecticut, 06320

  • Novartis Investigative Site

    New Orleans, Louisiana, 70115

  • Novartis Investigative Site

    New York, New York, 10003

  • Novartis Investigative Site

    Nixa, Missouri, 65714-7807

  • Novartis Investigative Site

    Norfolk, Virginia, 23507

  • Novartis Investigative Site

    North Dartmouth, Massachusetts, 02747

  • Novartis Investigative Site

    North Kansas City, Missouri, 64116

  • Novartis Investigative Site

    North Palm Beach, Florida, 33408

  • Novartis Investigative Site

    North Richland Hills, Texas, 76180

  • Novartis Investigative Site

    Northbrook, Illinois, 60062

  • Novartis Investigative Site

    Oceanside, California, 92056

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73104

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Novartis Investigative Site

    Old Point Station, South Carolina, 29707

  • Novartis Investigative Site

    Orem, Utah, 84058

  • Novartis Investigative Site

    Overland Park, Kansas

  • Novartis Investigative Site

    Patchogue, New York, 11772

  • Novartis Investigative Site

    Phoenix, Arizona, 85004

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15212

  • Novartis Investigative Site

    Plano, Texas, 75075

  • Novartis Investigative Site

    Plantation, Florida, 33324

  • Novartis Investigative Site

    Pompano Beach, Florida, 33060

  • Novartis Investigative Site

    Port Charlotte, Florida, 33952

  • Novartis Investigative Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Round Rock, Texas, 78681

  • Novartis Investigative Site

    Salisbury, North Carolina, 28144

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Francisco, California, 94117

  • Novartis Investigative Site

    Sarasota, Florida, 34233

  • Novartis Investigative Site

    Sarasota, Florida, 34243

  • Novartis Investigative Site

    Seattle, Washington, 98101

  • Novartis Investigative Site

    Sherwood, Arkansas, 72120

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29302

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29307

  • Novartis Investigative Site

    Springfield, Massachusetts, 01104

  • Novartis Investigative Site

    St Louis, Missouri, 63104

  • Novartis Investigative Site

    St. Petersburg, Florida, 33713

  • Novartis Investigative Site

    Sun City, Arizona, 85351

  • Novartis Investigative Site

    Suwanee, Georgia, 30024

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tampa, Florida, 33609

  • Novartis Investigative Site

    Teaneck, New Jersey, 07666

  • Novartis Investigative Site

    The Bronx, New York, 10467-2490

  • Novartis Investigative Site

    Toledo, Ohio, 43623

  • Novartis Investigative Site

    Toms River, New Jersey, 08755

  • Novartis Investigative Site

    Traverse City, Michigan, 49684-2340

  • Novartis Investigative Site

    Tucson, Arizona, 85741

  • Novartis Investigative Site

    Vienna, Virginia, 22182

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Watertown, Massachusetts, 02472

  • Novartis Investigative Site

    West Palm Beach, Florida, 33407

  • Novartis Investigative Site

    Wichita, Kansas, 67214

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

  • Novartis Investigative Site

    Worcester, Massachusetts, 01608

Other trials in United States

Puerto Rico1 site

  • Novartis Investigative Site

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)

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.

Read the detailed description

852 Patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved first line DMTs. Patients must be either treatment naive or have received treatment with only one class of treatment (interferon beta preparation or glatiramer acetate) . Patients previously treated with DMT and randomized to the DMT arm may not remain on the same treatment for the study and will have to switch to a different class (i.e., previously treated with glatiramer acetate will switch to interferon beta preparaption, previously treated with interferon beta preparation will swtich to glatiramer acetate).

Entry criteria at screening include but are not limited to, age 18-65, diagnosis with RRMS, EDSS < or equal to 6, not pregnant or planning pregnancy and women of childbearing potential willing to use contraception throughout the study.

Exclusion criteria include but are not limited to - prior exposure to fingolimod, history of malignancy within 5 years, other than RRMS types of MS, other diseases of the immune system, active macular edema, systemic bacterial, viral or fungal infections, patients without vaccine against varicella zoster, receipt of live or attentuated vaccines within a month of screening, history of various cardiac conditions, presence of certain ECG abnormalities, resting heart rate < 45 bpm, symptomatic bradycardia, recurrent syncope, severe untreated sleep apnea, severe pulmonary conditions, various hepatic conditions, certain neurologic disorders, pregnancy.

Patients may switch treatment before 3 months for safety reasons only, after 3 months for safety, efficacy, tolerability or convenience. Treatment switch during the study may be to any of study approved treatments irrespective of prior treatment.

Patients randomized to fingolimod will need to have 6 hours of observation for signs and symptoms of bradycardia following administration of the first dose. Extended observation or overnight observation may be necessary under certain circumstances. 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. Exploratory objectives include annualized relapse rate, OCT, MRI evaluations, biomarkers and patient reported outcome measures.

Being tested
Fingolimod, Disease Modifying therapy
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

  • Disease Modifying therapyDrug

Study groups in NCT01623596
Study groupRoleWhat they receive
FingolimodExperimentalNot described
Receives: Drug: Fingolimod
Disease Modifying TherapyActive comparator2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Receives: Drug: Disease Modifying therapy

What is being measured

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

  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)

    Measured: at 12 months

Secondary outcomes (5)

  1. Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set

    Reasons for discontinuation in participants treated with fingolimod vs. DMT over 12 months of treatment

    Total discontinued (Primary reason): Fingolimod arm: 27, MS-DMT arm: 27 = 54 participants

    Total discontinued (Secondary reason): Fingolimod arm: 257, MS-DMT arm: 256 = 513 participants

    Throughout the study, investigators evaluated each patient for occurrence of randomized treatment discontinuation and determined the primary and secondary reasons for such discontinuation. At every visit, the investigator evaluated the patients and determined if they should continue on randomized treatment or change to alternative treatment. Treatment discontinuation was a clinically meaningful measure related to safety, efficacy, and tolerability over time, reflecting the therapeutic effectiveness of study treatment.

    Measured: at 12 months

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

    Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons

    The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.

    NOTE: Higher scores indicate better performance.

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

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

    Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons

    The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.

    NOTE: Higher scores indicate better performance.

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

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

    Summary statistics for percent change from month 12 in brain volume by visit (Randomized treatment / randomized phase) in patients treated with fingolimod vs.DMTs as measured by MRI

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

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

    Summary statistics for Medication Satisfaction Questionnaire[Question: "Overall, how satisfied are you with your current medication?"] (Randomized treatment / randomized phase): Fingolimod vs MS-DMT

    Measured: 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

Timeline

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

  1. First posted20 Jun 2012 (estimated)
  2. Study start8 Jun 2012
  3. Primary completion13 Jul 2015
  4. Study completion13 Jul 2015

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623596
Sponsor's protocol ID
CFTY720DUS09
Acronym
PREFERMS
Status last verified
Mar 2019
First submitted
18 Jun 2012
Last updated
5 Jan 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod and Disease Modifying therapy in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 123 sites in 2 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 62 inclusion and 0 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: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 Jan 2018). 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?

Participant Retention Rate Over 12 Months (time frame: at 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 NCT01623596.

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 5 Jan 2021.

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