Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride; Glatiramer Acetate; Interferon beta-1a; Interferon beta-1b; Interferon-beta

Criteria

Inclusion Criteria:

• Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.

• Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.

• An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.

• Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.

• Naïve to treatment with fingolimod.

Exclusion Criteria:

• A manifestation of MS other than those defined in the inclusion criteria.

• A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.

• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

• Patients with uncontrolled diabetes mellitus (HbA1c > 7%).

• Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply