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:
Biogen Idec
Collaborator:
Abbott Biotherapeutics Corp.
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01051349
First received: January 15, 2010
Last updated: August 9, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Daclizumab
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Daclizumab HYP
DAC HYP 150mg SQ every 4 weeks
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051349
Hide Study Locations
Hide Study LocationsLocations
| 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, 69035 | |
| Research Site | |
| Zaporozhye, Ukraine, 69600 | |
| 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: | August 9, 2012 |
| 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 May 16, 2013