Phase 4 N=382 Basic Science

A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod

Relapsing Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT03257358 ↗

Enrolled (actual)

382

Serious AEs

5.5%

Results posted

Jul 2020

Primary outcome: Primary: Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) — 404.4; 3.4; 7.6; 4.8 cells/uL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Fingolimod (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)	404.4; 3.4; 7.6; 4.8; -411.4; 0.8	—
PRIMARY Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	374.6; 16.3; 19.6; 18.3; -368.9; 1.1	—
PRIMARY Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	74.3; 22.8; 18.2; 21.7; -51.5; -2.0	—
PRIMARY Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)	53.8; 11.1; 7.6; 11.7; -43.6; -0.7	—
PRIMARY Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)	35.9; 1.1; 1.7; 1.6; -36.1; 0.5	—
PRIMARY Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)	55.5; 2.4; 3.1; 2.8; -53.2; 0.5	—
PRIMARY Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)	150.9; 1.8; 4.2; 3.3; -139.3; 1.2	—
PRIMARY Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	93.1; 5.6; 5.9; 6.1; -85.2; 0.0	—
PRIMARY Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	108.2; 63.8; 55.4; 52.6; -40.6; -12.5	—
PRIMARY Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)	201.1; 18.1; 15.0; 17.8; -181.4; -0.2	—
PRIMARY Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)	61.8; 3.3; 3.8; 4.0; -55.1; 0.3	—
PRIMARY Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)	12.3; 5.3; 4.8; 6.1; -7.4; 0.9	—
PRIMARY Change From Baseline to Month 6 in Monocytes (CD14+)	329.6; 251.7; 384.7; 379.2; 66.1; 123.1	—
PRIMARY Change From Baseline to Month 6 in Neutrophils (CD16+)	4041.4; 3717.9; 3505.4; 3312.6; -586.0; -439.6	—
PRIMARY Change From Baseline to Month 6 in NK Cells (CD56+)	166.4; 181.0; 133.6; 154.5; -29.4; -28.0	—
PRIMARY Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count	936.3; 64.4; 53.4; 71.3; -884.1; 1.4	—
PRIMARY Change From Baseline to Month 6 in Total CD4+ Differential Cell Count	49.40; 11.95; 11.08; 12.82; -39.09; 0.32	—
PRIMARY Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count	419.9; 124.6; 120.1; 116.8; -266.2; -13.5	—
PRIMARY Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)	21.86; 25.25; 25.33; 24.99; 4.63; -0.39	—
PRIMARY Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count	259.7; 21.4; 19.5; 21.8; -231.3; 0.1	—
PRIMARY Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)	13.97; 4.81; 5.38; 4.83; -8.53; 0.23	—
SECONDARY Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)	404.4; 3.4; -376.3; -0.8	—
SECONDARY Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	374.6; 16.3; -356.8; 3.9	—
SECONDARY Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	74.3; 22.8; -50.4; -3.3	—
SECONDARY Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)	53.8; 11.1; -42.3; -2.1	—
SECONDARY Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)	35.9; 1.1; -36.3; 0.4	—
SECONDARY Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)	55.5; 2.4; -52.1; 0.5	—
SECONDARY Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)	150.9; 1.8; -126.3; 0.6	—
SECONDARY Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	93.1; 5.6; -86.5; 0.0	—
SECONDARY Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	108.2; 63.8; -55.9; -15.9	—
SECONDARY Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)	201.11; 18.1; -177.0; -0.5	—
SECONDARY Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)	61.8; 3.3; -46.4; 1.4	—
SECONDARY Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)	12.3; 5.3; -7.7; 0.8	—
SECONDARY Change From Baseline to Month 12 in Monocytes (CD14+)	329.6; 251.7; 57.1; 112.4	—
SECONDARY Change From Baseline to Month 12 in Neutrophils (CD16+)	4041.4; 3717.9; -815.9; -345.0	—
SECONDARY Change From Baseline to Month 12 in NK Cells (CD56+)	166.4; 181.0; -32.6; -28.9	—
SECONDARY Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count	936.3; 64.4; -844.9; 0.7	—
SECONDARY Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)	49.40; 11.95; -37.90; 0.70	—
SECONDARY Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count	419.9; 124.6; -265.1; -11.6	—
SECONDARY Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)	21.86; 25.25; 4.33; 0.34	—
SECONDARY Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count	259.7; 21.4; -218.9; 1.0	—
SECONDARY Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)	13.97; 4.81; -8.86; 0.20	—
SECONDARY Multiple Sclerosis (MS) Relapses During Treatment	11; 13; 12; 13; 5; 5	—
SECONDARY Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment	11; 13; 7; 8; 7; 8	—
SECONDARY Change From Baseline in Patient Determined Disease Steps (PDDS)	1.7; 1.8; 1.8; 1.8; -0.1; -0.0	—
SECONDARY Change From Baseline in T2 Lesion Burden	8.1; 9.7; 6.5; 13.1; -0.8; 3.2	—
SECONDARY Change From Baseline for New Gd-Enhancing T1 Lesion Count	0.4; 0.2; 0.1; 0.2; -0.2; 0.2	—
SECONDARY Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)	1.273; 1.391; 0.038; 0.045; 0.040; 0.145	—

Summary

A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod

Eligibility Criteria

Inclusion Criteria

Diagnosis of relapsing forms of Multiple Sclerosis
Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who had a hypersensitivity reaction to fingolimod or any of the excipients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03257358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.