NCT01317004

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2011

Typical duration for phase_4

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 22, 2015

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

3.1 years

First QC Date

March 15, 2011

Results QC Date

May 29, 2015

Last Update Submit

June 18, 2015

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple sclerosisFingolimodDisease Modifying TherapyTSQM-9

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 6 months

Secondary Outcomes (6)

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

    baseline, 6 months

  • Change From Baseline in Patient-reported Fatigue

    6 months

  • Change From Baseline in Patient-Reported Effectiveness and Convenience

    6 months

  • Change From Baseline in Patient-reported Depression

    6 months

  • Change From Baseline in Patient-reported Health Related Quality of Life (QOL)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Fingolimod

EXPERIMENTAL

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

Drug: Fingolimod

Multiple Sclerosis Disease Modifying Treatment (MS DMT)

ACTIVE COMPARATOR

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.

Drug: Standard MS DMT

Interventions

FingolimodDRUG

0.5 mg/day oral capsule

Also known as: GILENYA™
Fingolimod
Standard MS DMTDRUG

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

Also known as: Avonex®,, Copaxone®,, Rebif®,, Betaferon®,, Extavia®
Multiple Sclerosis Disease Modifying Treatment (MS DMT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

Ponderano, BI, 13900, Italy

Location

Novartis Investigative Site

Caltanissetta, CL, 93100, Italy

Location

Novartis Investigative Site

Cuneo, CN, 12100, Italy

Location

Novartis Investigative Site

Como, CO, 22100, Italy

Location

Novartis Investigative Site

Catania, CT, 95122, Italy

Location

Novartis Investigative Site

Foggia, FG, 71100, Italy

Location

Novartis Investigative Site

Castelfiorentino, FI, 50051, Italy

Location

Novartis Investigative Site

Milan, MI, 20122, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

San Donato Milanese, MI, 20097, Italy

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Palermo, PA, 90129, Italy

Location

Novartis Investigative Site

Palermo, PA, 90146, Italy

Location

Novartis Investigative Site

Pisa, PI, 56126, Italy

Location

Novartis Investigative Site

Legnago, VR, 37045, Italy

Location

Novartis Investigative Site

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Fingolimod HydrochlorideInterferon beta-1aGlatiramer AcetateInterferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAminesInterferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Renato Turrini, MD

    Novartis Farma S.p.A.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 22, 2015

Results First Posted

June 22, 2015

Record last verified: 2015-06

Locations

IT(17)