Clinical trial NCT00870740: Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
Official title: A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: MS
Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2009-03-27
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:

* An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
* An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
* An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
* An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.

The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

Detailed description: This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.

Eligibility criteria: Key Inclusion Criteria:

* Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.

Key Exclusion Criteria:

* Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
* Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
* Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: Up to 72 weeks
measure: Number of Participants With Abnormalities in Vital Signs
timeFrame: Up to Week 72
measure: Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
timeFrame: Up to 72 Weeks
measure: Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
timeFrame: Up to 72 Weeks
measure: Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
timeFrame: Up to 72 weeks
Secondary outcomes:
measure: Adjusted Annualized Relapse Rate
timeFrame: Up to 72 weeks
measure: Estimated Proportion of Participants With a Relapse
timeFrame: Up to 72 weeks
measure: Mean Number of New Gadolinium-enhancing Lesions
timeFrame: Week 20, Week 52
measure: Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
timeFrame: Baseline, Week 20, Week 52
measure: Mean Volume of New T1 Hypointense Lesions
timeFrame: Baseline, Week 20, Week 52
measure: Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions
timeFrame: Baseline, Week 52
measure: Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions
timeFrame: Baseline, Week 52
measure: Rate of Percentage Change From Baseline in Mean Total Brain Volume
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Research Site
city: Hraddec Kralove
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Prague
country: Czech Republic
facility: Research Site
city: Teplice
country: Czech Republic
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Osnabruck
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Siofok
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Andra-Pradeash
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Visakhapatnam
country: India
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Yaroskavl
country: Russian Federation
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
city: Devon
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Stoke-on-Trent
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.
citation: Giovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, McNeill M, Amaravadi L, Sweetser M, Elkins J, O'Neill G; SELECTION Study Investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.