| CTRI Number |
CTRI/2014/04/004551 [Registered on: 21/04/2014] Trial Registered Prospectively |
| Last Modified On: |
16/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This is an open label extension study of an on-going study where same subjects will be treated with drug - Daclizumab, to further evaluate the long term safety and efficacy of the drug. |
|
Scientific Title of Study
|
A Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301. |
| Trial Acronym |
205MS303 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2012-003176-39 |
EudraCT |
| 205MS303 version 1.0 dated 28 Sep 2012 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sect0r-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 |
Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sect0r-50, Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India |
| Phone |
9717004620 |
| Fax |
|
| Email |
ritika.bajaj@biogen.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Bajaj |
| Designation |
Clinical Reseach Country Head |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Vatika Towers
B Block
12th Floor
Sector 54
Golf Course Road
Gurgaon
HARYANA
122022
India |
| Phone |
01244572311 |
| Fax |
01244572370 |
| Email |
ritika.bajaj@biogenidec.com |
|
|
Source of Monetary or Material Support
|
| Biogen Idec Research Limited, Innovation House
70 Norden Road
Maidenhead, Berkshire
SL6 4AY
United Kingdom |
|
|
Primary Sponsor
|
| Name |
Biogen Idec MA Inc |
| Address |
14 Cambridge Center
Cambridge
MA 02142
USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biogen Idec Research Limited |
Innovation House
70 Norden Road
Maidenhead, Berkshire
SL6 4AY
United Kingdom |
|
|
Countries of Recruitment
|
Argentina
Australia
Brazil
Canada
Czech Republic
Denmark
Finland
France
Georgia
Germany
Greece
Hungary
India
Ireland
Israel
Italy
Mexico
Poland
Romania
Russian Federation
Serbia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shamsher Dwivedee |
Fortis Memorial Research Hospital |
Opposite HUDA City Centre Metro Station, Sector 44, Gurgaon, Haryana - 122002
Gurgaon
HARYANA |
09810084300
sdclinical@gmail.com |
| Dr Srinivasa Rangashetty |
M S Ramaiah Memorial Hospital, |
MSRIT Post, MSR Nagar,
New BEL Road,
Bangalore - 560054, India
Bangalore
KARNATAKA |
09448040589
drrsrinivasa@hotmail.com |
| Dr Meena Kanikannan |
Nizams Institute of Medical Sciences (NIMS), |
Punjagutta,
Hyderabad - 500082,
India
Hyderabad
ANDHRA PRADESH |
09866190476
meenaak@hotmail.com |
| Dr Roop Gursahani |
PD Hinduja National Hospital and Medical Research Center |
V. S. Marg, Mahim,
Mumbai - 400016, India
Mumbai (Suburban)
MAHARASHTRA |
09821087597
roop_gursahani@hotmail.com |
| Dr M D Nair |
Sree Chitra Tirunal Institute of Medical Sciences and Technology |
Department of Neurology,
Trivandrum,
Kerala - 695011, India
Thiruvananthapuram
KERALA |
09447553506
mdnair@sctimst.ac.in |
| Dr Thomas Mathew |
St. John’s Medical College Hospital |
Sarjapur Road– 560 034,India
Bangalore
KARNATAKA |
08022065635
chakkuthom@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethical Review Board, MS Ramaiah Hospital, Bangalore |
Approved |
| Institutional Ethics Committee , (Dr. Thomas Mathew) |
Approved |
| Institutional Ethics Committee, Fortis Memorial Research Institute, Gurgaon |
Approved |
| Institutional Ethics Committee, NIMS, Hyderabad |
Approved |
| Institutional Ethics Committee, PD Hinduja Hospital, Mumbai |
Approved |
| Institutional Ethics Committee, SCTIMST, Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Relapsing Remitting Multiple Sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Daclizumab High Yield Process (DAC HYP)/ Dose: 150mg/ml, Frequency: Once in a month / Mode of administration: Subcutaneous (SC) |
DAC HYP is supplied as a liquid in a 1-mL BD-staked PFS with a 29 gauge × ½ inch needle, comprising 150 mg/mL DAC HYP plus excipient materials (sodium succinate, sodium chloride, and polysorbate 80). |
| Comparator Agent |
No comparator agent. Open label study. |
No comparator agent. Open label study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
To be eligible to participate in this study, candidates must meet the following eligibility criteria at the 205MS303 Baseline Visit or at the timepoint specified in the individual eligibility criterion listed:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96).
Note: Subjects who are not able to enroll into 205MS303 at the time of their Week 144/End of Study Visit may be eligible to enroll into 205MS303 at a later time if they are still participating in the 6-month follow-up period of 205MS301 at the time of expected rollover into 205MS303.
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 |
Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Study 205MS303 Baseline Visit or at the timepoint specified in the individual criterion listed (Note: Day 1 is the day of the first dose in Study 205MS303):
Medical History
1. Any subject who permanently discontinued study treatment in Study 205MS301 prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301.
Note: Subjects for whom dosing was temporarily suspended in Study 205MS301 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the Study 205MS301 protocol have been met at the time of enrollment into Study 205MS303.
2. Any significant change in the subject’s medical history 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 Study 205MS301. The Investigator must re-review the subject’s medical fitness for participation and consider any factors that would preclude treatment in Study 205MS303, including: History of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal,neurological (other than MS), and/or other major disease (e.g., malignancy) that would preclude administration of DAC HYP. Clinically significant laboratory abnormalities (hematology and blood chemistry) from the most recently available test in Study 205MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in Protocol 205MS301 are exclusionary.
3. Any of the following abnormal blood tests within the 7 days prior to Day 1: alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) 3 the upper limit of normal (ULN)
Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until ALT/SGPT and AST/SGOT are 2 ULN. total bilirubin 2 ULN (subjects with an established diagnosis of Gilberts syndrome are excluded if total bilirubin is 2.5 ULN)
Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until total bilirubin 1 ULN (subjects with an established diagnosis of Gilberts syndrome may not enroll into 205MS303 until total bilirubin is 1.5 ULN).
4. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
Treatment History
5. Treatment with any prohibited concomitant medication during Study 205MS301.
Miscellaneous
6. Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study.
7. Previous participation in Study 205MS303.
8. History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS301.
9. 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301. |
144 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the long-term immunogenicity of DAC HYP administered by PFS
2. To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP
3. To assess the safety, tolerability, and efficacy of switching to DAC HYP in subjects previously on long-term treatment with interferon β-1a in Study 205MS301
4. To evaluate PD parameters that may be associated with treatment response. |
144 weeks |
|
|
Target Sample Size
|
Total Sample Size="1841"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/02/2013 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
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
|
This study will provide subjects who complete Phase 3 Study 205MS301 with the opportunity to receive open-label DAC HYP monotherapy prior to local product marketing approval for evaluation of long-term safety, efficacy, and immunogenicity of DAC HYP in subjects with RRMS. No new patients will be recruited (screened or enrolled) for the study. Patients on-going in trial 205MS301 study will be rolled over to this extention phase of the study. CTRI registration number of 205MS301 study is: REFCTRI/2010/000254 |