STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

Novartis

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: FTY720

Study type

Interventional

Funder types

Industry

Identifiers

NCT01585298

CFTY720DDE17

Details and patient eligibility

About

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.

Enrollment

6,998 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Subjects with relapsing remitting MS.
Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key Exclusion Criteria:

immunocompromised patients
active infections
pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
presence of malignancy (other than localized basal cell carcinoma of the skin).