NCT01317004 - Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change | Crick

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

61

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

FingolimodDRUG

0.5 mg/day oral capsule

Standard MS DMTDRUG

Interferon beta 1a or interferon beta 1b or Glatiramer Acetate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (17)

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Ponderano, BI, Italy

Novartis Investigative Site

Outcomes

Primary Outcomes

Change From Baseline in Patient-reported Treatment Satisfaction

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.

Time frame: baseline, 6 months

Secondary Outcomes

Change From Baseline in Patient-reported Activities of Daily Living (ADL)

The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.

Time frame: baseline, 6 months

Change From Baseline in Patient-reported Fatigue

The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.

Time frame: 6 months

Change From Baseline in Patient-Reported Effectiveness and Convenience

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.