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

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Fingolimod; Drug: Standard MS DMT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01317004

2010-024017-31 (EudraCT Number)

CFTY720DIT02

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Fingolimod

Experimental group

Description:

Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.

Treatment:

Drug: Fingolimod

Multiple Sclerosis Disease Modifying Treatment (MS DMT)

Active Comparator group

Description:

Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.

Treatment:

Drug: Standard MS DMT