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Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Phase 4 trial testing Fingolimod (FTY720) in Relapsing Remitting Multiple Sclerosis in 347 participants. Completed in 26 December 2015.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 347 |
| Start date | 24 December 2011 |
| Primary completion | 26 December 2015 |
| Estimated completion | 26 December 2015 |
| Sites | 47 locations across Australia, Spain |
Novartis Pharmaceuticals — full company profile →
Adults 18 to 50, any sex, with Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ARR = 365 days \* number of relapses / total days taking the study medication.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 0.290 | ± 0.7399 |
| Previously Treated With First-line DMTs Participants | 0.354 | ± 0.8547 |
Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | NA | NA – NA |
| Previously Treated With First-line DMTs Participants | NA | NA – NA |
The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 0.000 | ± 0.8040 |
| Previously Treated With First-line DMTs Participants | -0.077 | ± 0.7911 |
Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | -0.595 | -0.759 – -0.431 |
| Previously Treated With First-line DMTs Participants | -0.387 | -0.583 – -0.191 |
The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 42.55 | |
| Previously Treated With First-line DMTs Participants | 38.46 |
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 57.45 | |
| Previously Treated With First-line DMTs Participants | 56.41 |
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 0.00 | |
| Previously Treated With First-line DMTs Participants | 5.13 |
Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 71.89 | |
| Previously Treated With First-line DMTs Participants | 66.67 |
The mean number of new or enlarged T2 active lesions was assessed by MRI.
| Group | Value | 95% CI |
|---|---|---|
| Naive or de Novo Participants | 2.0 | ± 3.36 |
| Previously Treated With First-line DMTs Participants | 1.6 | ± 2.72 |
Time frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, approximately 4 years.. Reporting threshold: 0.0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Naive or de Novo Participa… | Previously Treated With Fi… | All Participants |
|---|---|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — |
| Atrioventricular block | Cardiac disorders | — | — | — |
| Atrioventricular block second degree | Cardiac disorders | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — |
| Hepatitis acute | Hepatobiliary disorders | — | — | — |
| Drug hypersensitivity | Immune system disorders | — | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — | — |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Brain oedema | Nervous system disorders | — | — | — |
| Epilepsy | Nervous system disorders | — | — | — |
| Partial seizures | Nervous system disorders | — | — | — |
| Ovarian cyst | Reproductive system and breast disorders | — | — | — |
| Reaction | System | Naive or de Novo Participa… | Previously Treated With Fi… | All Participants |
|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Fatigue | General disorders | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Oral herpes | Infections and infestations | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Migraine | Nervous system disorders | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Tonsillitis | Infections and infestations | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Vulvovaginal candidiasis | Infections and infestations | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Hypercholesterolaemia | Metabolism and nutrition disorders | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Respiratory tract infection | Infections and infestations | — | — | — |
| Vision blurred | Eye disorders | — | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — | — |
| Visual impairment | Eye disorders | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — |
| Gastritis | Gastrointestinal disorders | — | — | — |
| Chest pain | General disorders | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — |
Most-reported serious reactions: Multiple sclerosis relapse, Sinus bradycardia, Cholelithiasis, Atrioventricular block, Atrioventricular block second degree, Bradycardia, Hepatitis acute, Drug hypersensitivity.
Data from ClinicalTrials.gov NCT01498887 adverse events section.
This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01498887.
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