Evaluation of Patient Retention of Fingolimod vs. Currently Approved D
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)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Compared with
- Disease Modifying therapy
Results by group
Participant Retention Rate Over 12 Months
at 12 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 352 participants | 436 | |
| Disease Modifying Therapy (MS-DMT) | 125 participants | 439 |
Fingolimod
Disease Modifying Therapy (MS-DMT)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod | 433 | 29 (6.7%) | |
| MS DMT | 428 | 15 (3.5%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Participant Retention Rate Over 12 Months
at 12 months
Feasibility
Other measures (5)
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
at 12 months
SafetyChange 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
Thinking and memoryChange 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
Thinking and memoryPercent 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
MRI lesionsBrain volume lossNumber 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
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
1. written informed consent must be obtained prior to any assessment being performed. 2. Male and female patients aged 18-65 years inclusive. 3. Patients diagnosed with relapsing remitting MS, defined by the 2010 revised McDonald criteria (Pollman et al, 2011) (Appendix 1). 4. EDSS score of less than or equal to 6. 5. 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. 6. Patients who have been treated with DMF for less than 2 months total exposure and who have a normal lymphocyte count at screening. 7. Women of childbearing potential must have a negative urine and serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and at baseline. 8. 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 <!-- --> 1. Use of other investigational drugs within 30 days of screening. 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 3. Prior exposure to fingolimod or any other S1P receptor modulating compounds. 4. 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. 5. Patients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Primary Progressive MS (PPMS). 6. Patients with a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome. 7. 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. 8. 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. 9. Patients with uncontrolled diabetes mellitus (HbA1c > 7%). 10. 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. 11. 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. 12. 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). 13. Patients who have received any live or live attenuated vaccines (including for varicella-zoster or measles) within 1 month prior to baseline. 14. Patients with any medically unstable condition as assessed by the investigator. 15. 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 16. Patients with severe pulmonary conditions (including severe respiratory disease, pulmonary fibrosis, active tuberculosis, severe or poorly controlled asthma). 17. 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 18. Serum creatinine greater than 2.0 mg/dL (176.5 µmol/L) at screening. 19. 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 20. Women who are pregnant or nursing (lactating) or planning to become pregnant. 21. 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. 22. Pre-planned surgery or medical procedure that would interfere with the conduct of the study. 23. Employee of the sponsor, investigator or study ce
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jun 2012
Main results due
Jul 2015
Finished
Jul 2015
Results posted
Jan 2018