MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone (ASSESS)
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|ClinicalTrials.gov Identifier: NCT01633112|
Recruitment Status : Terminated (slow recruitment)
First Posted : July 4, 2012
Results First Posted : May 28, 2019
Last Update Posted : May 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-remitting Multiple Sclerosis (RRMS)||Drug: fingolimod Drug: glatiramer acetate||Phase 3|
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).
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1064 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Fingolimod patients were dose blind.|
|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|
|Actual Study Start Date :||August 9, 2012|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
Experimental: fingolimod 0.5 mg
orally once daily
Experimental: fingolimod 0.25mg
orally once daily
Active Comparator: glatiramer acetate 20 mg
subcutaneous once daily
Drug: glatiramer acetate
Other Name: Copaxone, Glatopa
- Confirmed Annualized Relapse Rate [ Time Frame: up to 12 months ]Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.
- New or Newly Enlarging T2 Lesions [ Time Frame: At 12 months/end of study ]Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
- Number of Participants Free of New/Newly Enlarged T2 Lesions [ Time Frame: At 12 months/end of study ]Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
- Change From Baseline in T2 Lesion Volume [ Time Frame: Baseline, 12 months/end of study ]Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume
- Gd Enhancing T1 Lesion Count [ Time Frame: At 12 months/end of study ]Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
- Gd Enhancing T1 Lesion Volume [ Time Frame: Baseline, 12 months/end of study ]Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
- Percentage of Patients Free of New T1 Hypointense Lesions [ Time Frame: 12 months ]Based on MRI measures of new T1 hypointense lesions
- Change From Baseline in TSQM Scales [ Time Frame: 6 months, 12 months/end of study ]Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0—100 scale. Higher summary scores indicate better satisfaction with study drug.
- Percent Brain Volume Change From Baseline [ Time Frame: Baseline, 12 months, end of study ]Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633112
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|