Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing Remitting Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott Biotherapeutics Corp.
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01051349
First received: January 15, 2010
Last updated: September 12, 2013
Last verified: August 2012
  Purpose

Extended DAC HYP monotherapy from study 205MS202 in order to evaluate long term safety and efficacy of DAC HYP in subjects with relapsing remitting multiple sclerosis (MS).


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Daclizumab HYP
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To assess the safety of extended treatment with DAC HYP monotherapy and the long term immunogenicity of DAC HYP, AEs, laboratory evaluations, vital signs, physical examinations, and immunogenicity (the incidence of development of antibodies to DAC HYP) [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The durability of DAC HYP measured by brain MRI (new gd enhancing lesions, new or newly enlarging T2 hyperintense lesions, vol of new T1 hypointense lesions; total lesion vol of T2 hyperintense lesions; vol of non gd enhancing T1 hypointense lesions [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Daclizumab HYP
    DAC HYP 150mg SQ every 4 weeks
Detailed Description:

This study will provide subjects who complete Study 205MS202 with the option to receive continued open-label DAC HYP monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in subjects with RRMS.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be a subject from Study 205MS202 for at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator

Exclusion Criteria:

  • Subjects with any significant change in their medical status from the previous study that would prelude administration of DAC HYP as determined by the Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051349

  Hide Study Locations
Locations
Czech Republic
Research Site
Brno, Czech Republic, 65691
Research Site
Brno, Czech Republic, 62500
Research Site
Hradec Kralove, Czech Republic, 50005
Research Site
Prague, Czech Republic, 10034
Research Site
Teplice, Czech Republic, 41529
Germany
Research Site
Bayreuth,, Germany, 95445
Research Site
Erlangen, Germany, 91054
Research Site
Marburg, Germany, 35043
Research Site
Regensburg, Germany, 93053
Research Site
Rostock, Germany, 18147
Hungary
Research Site
Budapest, Hungary, 1076
Research Site
Budapest, Hungary, 1083
Research Site
Budapest, Hungary, 1134
Research Site
Budapest, Hungary, 1115
Research Site
Budapest, Hungary, 1125
Research Site
Debrecen, Hungary, 4032
Research Site
Debrecen, Hungary, 4012
Research Site
Esztergom, Hungary, 2500
Research Site
Gyor, Hungary, 9024
Research Site
Kecskemet, Hungary, 6000
Research Site
Miskolc, Hungary, 3529
Research Site
Miskolc, Hungary, 3533
Research Site
Nyiregyhaza, Hungary, 4400
Research Site
Siofok, Hungary, 8600
India
Research Site
Andra-Pradeash, India, 500082
Research Site
Bangalore, India, 560034
Research Site
Kolkata, India, 700068
Research Site
Mumbai, India, 400012
Research Site
Rajastan, India, 302017
Poland
Research Site
Bialystok, Poland, 15276
Research Site
Bialystok, Poland, 15420
Research Site
Gdansk, Poland, 80803
Research Site
Katowice, Poland, 40752
Research Site
Katowice, Poland, 40684
Research Site
Krakow, Poland, 31505
Coordinating Research Site
Lodz, Poland, 90153
Research Site
Lublin, Poland, 20954
Research Site
Warsaw, Poland, 2957
Research Site
Warszawa, Poland, 2097
Russian Federation
Research Site
Kazan, Russian Federation, 420021
Research Site
Krasnoyarsk, Russian Federation, 660049
Research Site
Moscow, Russian Federation, 107150
Research Site
Moscow, Russian Federation, 115682
Research Site
Moscow, Russian Federation, 127018
Research Site
Nizhniy Novgorod, Russian Federation, 603076
Research Site
Novosibirsk, Russian Federation, 630087
Research Site
Omsk, Russian Federation, 644033
Research Site
Samara, Russian Federation, 443095
Research Site
Smolensk, Russian Federation, 214018
Research Site
St Petersburg, Russian Federation, 194291
Research Site
Ufa, Russian Federation, 450005
Research Site
Yaroskavi, Russian Federation, 150030
Ukraine
Research Site
Chernivtsy, Ukraine, 58018
Research Site
Dnipropetrovsk, Ukraine, 49027
Research Site
Donetsk, Ukraine, 83003
Research Site
Kharkiv, Ukraine, 61068
Research Site
Kiev, Ukraine, 2125
Research Site
Kiev, Ukraine, 3110
Research Site
Kyiv, Ukraine, 3110
Research Site
Poltava, Ukraine, 36024
Research Site
Zaporozhye, Ukraine, 69600
Research Site
Zaporozhye, Ukraine, 69035
United Kingdom
Research Site
London, United Kingdom, SE59RF
Research Site
Nottingham, United Kingdom, NG72UH
Research Site
Plymouth, United Kingdom, PL68DH
Research Site
Sheffield, United Kingdom, S102JF
Research Site
Stoke-on-Trent, United Kingdom, ST47LN
Sponsors and Collaborators
Biogen Idec
Abbott Biotherapeutics Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec Inc
ClinicalTrials.gov Identifier: NCT01051349     History of Changes
Other Study ID Numbers: 205-MS-203
Study First Received: January 15, 2010
Last Updated: September 12, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Biogen Idec:
MS
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014