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.

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— SELECTION  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870740
• Other study ID #: 205-MS-202
• Secondary ID: EUDRA CT No.: 20
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2009
• Last updated: October 13, 2014
• Start date: February 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: State Expert Centre of the Ministry of Health of UkraineCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsIndia: Drugs Controller General of IndiaGermany: Paul-Ehrlich-InstitutRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to assess the safety and immunogenicity of extended treatment with Daclizumab High Yield Process (DAC HYP). 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.

Description:

This study is an extension to the Daclizumab High Yield Process (DAC HYP) therapy from Study 205MS201 (NCT00390221) to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in multiple sclerosis (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 205MS201, will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: October 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 56 Years

Eligibility

Key Inclusion Criteria:

• Must be a subject from Study 205MS201 (NCT00390221) for at least 52 weeks and must have been 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 (NCT00390221) that would preclude administration of Daclizumab High Yield Process (DAC HYP), as determined by the Investigator

• Any subject who has permanently discontinued study treatment in Study 205MS201 (NCT00390221) except subjects who were unblinded during evaluation of an adverse event (AE)

• Planned ongoing treatment with any approved or experimental treatment for multiple sclerosis (MS) except for the protocol-allowed use of concomitant interferon (IFN)-beta NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection

Drug:
• Placebo
Placebo SC injection

Locations

Country	Name	City	State
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Prague
Czech Republic	Research Site	Teplice
Germany	Research Site	Bayreuth,
Germany	Research Site	Berlin
Germany	Research Site	Erlangen
Germany	Research Site	Marburg
Germany	Research Site	Osnabrueck
Germany	Research Site	Regensburg
Germany	Research Site	Rostock
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Debrecen
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Kecskemet
Hungary	Research Site	Miskolc
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Siofok
Hungary	Research Site	Zalaegerszeg
India	Research Site	Andra-Pradeash
India	Research Site	Bangalore
India	Research Site	Chennai
India	Research Site	Kolkata
India	Research Site	Mumbai
India	Research Site	Pune
India	Research Site	Rajastan
India	Research Site	Vishakhapatnam
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Coordinating Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Warsaw
Poland	Research Site	Warszawa
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	St Petersburg
Russian Federation	Research Site	St Petersburg
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Yaroskavi
Ukraine	Research Site	Chernivtsy
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Kiev
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Poltava
Ukraine	Research Site	Zaporozhye
Ukraine	Research Site	Zaporozhye
United Kingdom	Research Site	London
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Stoke-on-Trent

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	AbbVie

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  India,  Poland,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events and abnormal Laboratory Evaluations, Vital Signs and Physical Examinations		Up to 72 weeks	Yes
Primary	Number of participants with development of antibodies to DAC HYP		Up to 72 weeks	Yes
Secondary	Annualized relapse rate	Relapses are defined as new or recurrent neurologic 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 annualized relapse rate will be calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.	Up to 72 weeks	No
Secondary	The percentage of participants who are relapse free	Relapses are defined as new or recurrent neurologic 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.	Up to 72 weeks	No
Secondary	The number of new Gadolinium-enhancing lesions	Evaluated by magnetic resonance imaging (MRI) by a central reader.	Up to 72 weeks	No
Secondary	The number of new or newly-enlarging T2 hyperintense lesions	Evaluated by magnetic resonance imaging (MRI) by a central reader.	Up to 72 weeks	No
Secondary	The volume of new T1 hypointense lesions	Evaluated by magnetic resonance imaging (MRI) by a central reader.	Up to 72 weeks	No
Secondary	The total lesion volume of T2 hyperintense lesions	Evaluated by magnetic resonance imaging (MRI) by a central reader.	Up to 72 weeks	No
Secondary	The volume of non-Gadolinium-enhancing T1 hypointense lesions	Evaluated by magnetic resonance imaging (MRI) by a central reader.	Up to 72 weeks	No
Secondary	Total brain volume	To assess brain atrophy, total brain volume will be measured by magnetic resonance imaging (MRI) and analyzed by a central reader.	Up to 72 weeks	No

External Links

•   The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers.