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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


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
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