| CTRI Number |
CTRI/2012/05/002705 [Registered on: 28/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
24/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Long-term Extension Study to Evaluate the Safety and Efficacy of Daclizumab High Yield Process |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
SELECTED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2009-015318-23 |
EudraCT |
| 205MS203 dated 17 June 2011, version 2 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sector-50, Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India |
| Phone |
9717004620 |
| Fax |
|
| Email |
ritika.bajaj@biogen.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sector-50, Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India |
| Phone |
9717004620 |
| Fax |
|
| Email |
ritika.bajaj@biogen.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sector-50, Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India |
| Phone |
9717004620 |
| Fax |
|
| Email |
ritika.bajaj@biogen.com |
|
|
Source of Monetary or Material Support
|
|
Biogen Idec Ltd.
Innovation House
70 Norden Road
Maidenhead Berkshire SL6 4AY
United Kingdom
|
|
|
Primary Sponsor
|
| Name |
Biogen Idec |
| Address |
Biogen Idec Ltd.
Innovation House, 70 Norden Road, Maidenhead Berkshire SL6 4AY,United Kingdom (UK)
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biogen Idec Biotech India Pvt Ltd |
14th Floor, Block -B, Vatika Towers, Sector - 54, Golf course road, Gurgaon 122022, Haryana, India |
|
|
Countries of Recruitment
|
Czech Republic
Germany
Hungary
India
Poland
Russian Federation
Ukraine
United Kingdom |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajaram Agrawal |
Brain Care |
Brain Care
Room: A 195
Vidyut Nagar
Prince Road
Ajmer Road
Jaipur 302021
Jaipur
RAJASTHAN |
91-9829063895
91-141-4008151
drrajaram195@rediffmail.com |
| Dr Kanikannan Meena |
Nizams Institute of Medical Sciences |
Nizams Institute of Medical Sciences, Room No. 329 A, Millennium Block, Punjagutta Hyderabad 500082 India
Hyderabad
ANDHRA PRADESH |
9866190476
04066461365
meenaak@hotmail.com |
| Dr Sangeeta Ravat |
Seth G S Medical College and KEM Hospital |
Seth G S Medical College and KEM Hospital Ward No 223 224 226 2nd floor Old building Acharya Dhonde Marg Parel Mumbai 400012 India
Mumbai (Suburban)
MAHARASHTRA |
9820310850
02224164206
ravatsh@yahoo.com |
| Dr Pahari Ghosh |
Sri Aurobindo Seva Kendra |
Sri Aurobindo Seva Kendra Department of Neurology, Room:1H, Gariahat Road Kolkata 700068 India
Kolkata
WEST BENGAL |
9831023296
03324649830
ghosh.pahari@gmail.com |
| Dr Thomas Mathew |
St Johns Medical College Hospital |
St Johns Medical College and Hospital, Third floor, Room No 3, Sarjapur Road Kormangala Bangalore 560034 India
Bangalore
KARNATAKA |
9880247582
08025634479
chakkuthom@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subject |
Approved |
| Institutional Ethical Review Board St Johns Medical College Hospital Sarjapur Road Kormangala Bangalore 560 034 Karnataka India |
Approved |
| Institutional Ethics Committee, Nizam’s Institute of Medical Sciences, Millennium Block, Panjagutta, Hyderabad – 500082, Andhra Pradesh, India |
Approved |
| Swastik Ethics Committee, Laxmi Villa, B- 15/5, Shiv Marg, Bani Park, Jaipur- 302016, Rajasthan, India |
Approved |
| The Ethics Committee of Sri Aurobindo Seva Kendra, Department of Neurology, 1H, Gariahat Road , Kolkata-700068, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Relapsing-Remitting Multiple Sclerosis (RRMS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Daclizumab High Yield Process (DAC HYP) |
DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for 144 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.
2. Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator.
3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject’s participation in the 205MS201 or 205MS202 studies. The Investigator must re review the subject’s medical fitness for participation and must consider any diseases that would preclude treatment.
2. Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE.
3. Current enrollment in any investigational drug study other than Study 205MS202.
4. Ongoing treatment with any approved or experimental disease-modifying treatment for MS.
5. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study is to assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS |
144 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives of this study are to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population. |
• Immunogenicity
• Sustained disability progression defined by at least a 1.0-point increase on the EDSS from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS 1.0 that is sustained for 12 weeks
• Annual change in total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI
• ARR
|
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
31/03/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All subjects will receive one DAC HYP 150 mg SC injection every 4 weeks.
After the first 12 weeks in this study, subjects will have the option of administering DAC HYP at home. Subjects who are not able to administer their own dose or prefer not to administer their own dose of DAC HYP will be given the option to choose another individual to administer their treatment or to have their treatment administered by staff at the study site.
A protocol-defined futility analysis in the 205MS201 study did not find evidence of futility at the proposed dose of DAC HYP, which was originally selected based on the findings of the completed Phase 2 DAC-1012 study. Additionally, the ongoing safety review of the 205MS201 and 205MS202 studies supports continued dosing and initiation of home dosing for subjects who have previously tolerated DAC HYP dosing in the clinic. Prior to self-administration of DAC HYP as an SC injection in this study, subjects will have received DAC HYP for a minimum of 15 months and a maximum of 27 months comprising their treatment in the 205MS201 and 205MS202 studies plus the first 3 months of observed therapy in the current study. |