Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Relapsing-Remitting
Brief summary
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
Interventions
DRUGFingolimod
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with relapsing remitting Multiple Sclerosis * Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
Exclusion criteria
* Patients with MS other than relapsing remitting MS * Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. * Patients who have been treated with: * systemic corticosteroids or immunoglobulins within 1 month prior to baseline; * immunosuppressive medications within 3 months prior to baseline; * monoclonal antibodies within 3 months prior to baseline; * cladribine, mitoxantrone or alemtuzumab at any time. * Uncontrolled diabetes mellitus at screening * Diagnosis of macular edema during Screening Phase * Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. * Patients who have received total lymphoid irradiation or bone marrow transplantation. * Patients with certain cardiovascular conditions and/or findings in the screening ECG * Patients with certain liver conditions * Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 28 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | 4 months | The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting. |
Countries
Argentina, Brazil, Colombia, Jordan, Malaysia, Mexico, Panama, Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fingolimod 0.5 mg Open-label fingolimod 0.5 mg, taken orally once daily for 4 months | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Abnormal Lab Values | 4 |
| Overall Study | Abnormal Test Procedure Result | 1 |
| Overall Study | Adverse Event | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Fingolimod 0.5 mg |
|---|---|
| Age, Continuous | 37.3 Years STANDARD_DEVIATION 9.67 |
| Age, Customized 18-30 years | 47 Participants |
| Age, Customized <18 years | 0 Participants |
| Age, Customized 31-40 years | 60 Participants |
| Age, Customized 41-55 years | 47 Participants |
| Age, Customized 56-65 years | 8 Participants |
| Age, Customized >65 years | 0 Participants |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 162 |
| serious Total, serious adverse events | 12 / 162 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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
Time frame: 28 weeks
Population: Safety set includes all patients who received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fingolimod 0.5 mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events (AE) | 100 Participants |
| Fingolimod 0.5 mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Serious Adverse Event (SAE) | 12 Participants |
| Fingolimod 0.5 mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Deaths | 0 Participants |
Secondary
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.
Time frame: 4 months
Population: Safety set includes all patients who received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fingolimod 0.5 mg | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | Bradyarrhythmias | 8.6 Percent of Participants |
| Fingolimod 0.5 mg | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | Blood pressure increase | 0.6 Percent of Participants |
| Fingolimod 0.5 mg | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | Hypertension | 2.5 Percent of Participants |
| Fingolimod 0.5 mg | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | Liver Transaminase evaluations | 3.7 Percent of Participants |
| Fingolimod 0.5 mg | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | Infections | 28.4 Percent of Participants |
| Fingolimod 0.5 mg | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | Macula Oedema | 0 Percent of Participants |