Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Source: ClinicalTrials.gov NCT01498887 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Relapse Rate (ARR) |
0.290; 0.354 | 0.3118 |
| SECONDARY Time to First Relapse |
NA; NA | — |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) Score |
0.000; -0.077 | — |
| SECONDARY Change From Baseline in Cerebral Volume |
-0.595; -0.387 | — |
| SECONDARY Percentage of Participants With Mild, Moderate or Severe Relapse |
42.55; 38.46; 57.45; 56.41; 0.00; 5.13 | — |
| SECONDARY Percentage of Relapse-free Participants |
71.89; 66.67 | — |
| SECONDARY Mean Number of T2 Active Lesions |
2.0; 1.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
- Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.
Patients
- Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
- Previously treated with a first-line Disease Modifying Therapy
Exclusion Criteria
- Patients who have received treatment with:
Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.
- Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01498887). 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. Informational only — not medical advice.