Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab

Phase 3

Terminated

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions: Drug: Daclizumab

Registration Number: NCT02881567

Lead Sponsor: Biogen

Brief Summary: The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daclizumab	Daclizumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Relapse-free at Month 6	Month 6	Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12	Month 12	Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12	Months 6 and 12	New and newly enlarged T2 Hypointense Lesions were measured by MRI.
Number of Participants With Clinically Relevant Shifts in Laboratory Assessments	First dose of study drug to within 30 days of last dose (up to 11 months)	Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.
Annualized Relapse Rate (ARR) at Month 12	Month 12	Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of Month 12, and the ratio then multiplied by 365.
Percentage of Participants Relapse-free at Month 12	Month 12	Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12	Months 6 and 12	New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	First dose of study drug to within 30 days of last dose (up to 11 months)	An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death or in the view of the Investigator, places the participant at immediate risk of death or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or results in a birth defect.
Permanent Discontinuation Rate of Daclizumab at Month 12	Month 12	Permanent Discontinuation Rate was calculated as the ratio of number of participants who had permanently discontinued daclizumab prior to Month 12 over the total number of participants who received at least 1 dose of daclizumab in the study.