Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fingolimod · 11 trials · 7 indications
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine: * Seroconversion: The pre-vaccination antibody titer measurement was \<1:10 and the post-vaccination measurement is ≥1:40. * Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist). ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.
To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.
| Arm | Type | Description |
|---|---|---|
| ofatumumab - 20 mg injection/ placebo | EXPERIMENTAL | Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight). |
| siponimod - 0.5 mg, 1 mg or 2 mg/ placebo | EXPERIMENTAL | Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight). |
| fingolimod - 0.5 mg or 0.25 mg/ placebo | ACTIVE_COMPARATOR | Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight). |
| Fingolimod (FTY720) | EXPERIMENTAL | Participants received Fingolimod 0.5 mg orally once daily. |
| Placebo | PLACEBO_COMPARATOR | Participants received matching placebo to Fingolimod orally once daily. |
| Fingolimod | EXPERIMENTAL | Open-label fingolimod 0.5 mg, taken orally once daily for 4 months |
| Fingolimod 0.5 mg/day | EXPERIMENTAL | Open-label fingolimod 0.5 mg, taken orally once daily |
| Fingolimod 1.25 mg | EXPERIMENTAL | Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study. |
| Fingolimod 0.5 mg | EXPERIMENTAL | Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. |
| Placebo-fingolimod | EXPERIMENTAL | Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study. |
| Placebo-fingolimod 1.25 mg | EXPERIMENTAL | Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study. |
| Placebo-fingolimod 0.5 mg | EXPERIMENTAL | Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study. |
| Interferon β-1a 30 µg | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fingolimod | DRUG | Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight). |
| Ofatumumab | DRUG | Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight). |
| Siponimod | DRUG | Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight). |
| Fingolimod placebo | OTHER | Fingolimod matching placebo capsule |
| Siponimod placebo | OTHER | Siponimod matching placebo tablet |
| Ofatumumab placebo | OTHER | Ofatumumab matching placebo autoinjector |
| Placebo Comparator | DRUG | Matching placebo capsules |
| Placebo | DRUG | Matching placebo capsules for oral administration. |
| Seasonal influenza vaccine | BIOLOGICAL | Commercially available injectable influenza vaccine for the 2010/11 influenza season. |
| Tetanus toxoid vaccine | BIOLOGICAL | Commercially available tetanus toxoid vaccine booster injection. |
| Fingolimod 0.5 mg | DRUG | Patients self-administered fingolimod 0.5 mg capsules orally once daily. |
| Fingolimod 1.25 mg | DRUG | Patients self-administered fingolimod 1.25 mg capsules orally once daily. |
| Interferon β-1a 30 µg | DRUG | Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily. Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment. |
| fingolimod (FTY720) | DRUG | - |
Inclusion Criteria: 1. Between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization 2. Diagnosis of multiple sclerosis 3. EDSS score of 0 to 5.5, inclusive 4. At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior ...
Fingolimod is used for chronic inflammatory demyelinating polyradiculoneuropathy and multiple sclerosis, including relapsing forms of multiple sclerosis and relapsing-remitting multiple sclerosis. It is also studied in patients with renal insufficiency. Fingolimod is a small molecule being developed by Novartis AG for neurological conditions.
Fingolimod is a small molecule that modulates sphingosine 1-phosphate receptors, which are involved in lymphocyte trafficking. By preventing lymphocytes from leaving lymph nodes, it reduces the number of circulating immune cells that can attack the central nervous system, thereby decreasing inflammation and demyelination in multiple sclerosis.
Fingolimod is developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's efficacy and safety in multiple sclerosis and other neurological conditions.
Fingolimod is in Phase 3 clinical development for multiple sclerosis and related conditions. It has completed multiple Phase 3 trials, including studies in relapsing-remitting multiple sclerosis. The drug is investigational and has not been confirmed as approved based on the available data.
Fingolimod has been studied in several clinical trials, including NCT00289978, NCT00355134, and NCT00662649, all Phase 3 trials in relapsing-remitting multiple sclerosis. NCT00670449 is a Phase 2 extension study in relapsing multiple sclerosis. These trials have enrolled over 3,400 patients across multiple countries.
Yes, Fingolimod is also known as FTY720. Clinical trial records, such as NCT00355134 and NCT00662649, refer to the drug as Fingolimod (FTY720), confirming that these names identify the same investigational compound being developed by Novartis.