Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-11 @ 12:29 AM
Study NCT ID:
NCT01633112
Status:
TERMINATED
Last Update Posted:
2019-05-28
First Post:
2012-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSESS
Brief Summary:
The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS
Detailed Description:
This was a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS.
This study consisted of 3 periods:
* Screening Period: up to 45 days for all patients
* Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
* Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).
Treatment groups:
* fingolimod 0.5 mg/day orally for up to 12 months
* fingolimod 0.25 mg/day orally for up to 12 months
* glatiramer acetate 20 mg/day subcutaneously for up to 12 months
This study consisted of 3 periods:
* Screening Period: up to 45 days for all patients
* Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
* Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).
Treatment groups:
* fingolimod 0.5 mg/day orally for up to 12 months
* fingolimod 0.25 mg/day orally for up to 12 months
* glatiramer acetate 20 mg/day subcutaneously for up to 12 months
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: