Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies (ESCALATE)
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|ClinicalTrials.gov Identifier: NCT02241785|
Recruitment Status : Terminated (Business Decision)
First Posted : September 16, 2014
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Multiple Sclerosis||Drug: natalizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)|
|Actual Study Start Date :||September 30, 2014|
|Actual Primary Completion Date :||May 2, 2016|
|Actual Study Completion Date :||May 2, 2016|
natalizumab 300 mg intravenously (IV) every 4 weeks
Administered as specified in the treatment arm
- Proportion of Participants With No Evidence of Disease Activity (NEDA) From Reset Baseline (Week 8) to Week 56 [ Time Frame: Reset Baseline (Week 8) to Week 56 ]The proportion of participants with NEDA, defined as follows: no Expanded Disability Status Scale (EDSS) progression (12-week sustained); no relapses; no gadolinium enhancing (Gd+) lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of combined unique active (CUA) lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
- Change in T1 Unenhancing Lesion Volume and T2 Lesion Volume From Baseline (Day -1) to Reset Baseline (Week 8) [ Time Frame: Baseline (Day -1) to Reset Baseline (Week 8) ]As measured by magnetic resonance imaging.
- Proportion of Participants With NEDA From Week 8 (Reset Baseline) to Week 104 [ Time Frame: from Week 8 (Reset Baseline) to Week 104 ]Proportion of participants with NEDA from Week 8 (Reset Baseline) to Week 104 (with no 12-week confirmed EDSS progression determined at Week 116). NEDA was defined as follows: no EDSS progression (12-week sustained); no relapses; no Gd+ lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of CUA lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
- Pre- and Post-Natalizumab Infusion Annualized Relapse Rate (ARR) Comparison at Month 12 [ Time Frame: From 12 months prior to natalizumab infusion and 12 months post-natalizumab infusion ]An MS relapse was defined as the onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination, and not explained solely by non-MS processes such as fever, infection, severe stress, or drug toxicity. 95% confidence interval is based on a Poisson regression model.
- Change in MSIS-29 Physical Impact Scores From Baseline (Day -1) to Reset Baseline (Week 8) [ Time Frame: Baseline (Day -1) to Reset Baseline (Week 8) ]The MSIS-29 is a brief self-administered MS-specific instrument measuring physical (20 items) and mental/psychological (9 items) impact of MS. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
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): NCT02241785
|United States, California|
|Fullerton, California, United States, 92835|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Iowa|
|Des Moines, Iowa, United States, 50314|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Plainview, New York, United States, 11803|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27607-6010|
|United States, Ohio|
|Akron, Ohio, United States, 44320|
|Cleveland, Ohio, United States, 44195|
|United States, Tennessee|
|Knoxville, Tennessee, United States, 37922|
|United States, Texas|
|Round Rock, Texas, United States, 78681|
|United States, Washington|
|Tacoma, Washington, United States, 98405|
|Study Director:||Medical Director||Biogen|