| CTRI Number |
CTRI/2011/12/002229 [Registered on: 14/12/2011] Trial Registered Prospectively |
| Last Modified On: |
24/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To determine if BIIB017 is safe and tolerable enough in patients with Relapsing Multiple Sclerosis on a long term duration. |
|
Scientific Title of Study
|
A Dose-Frequency Blinded, Multicenter, Extension Study to determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis |
| Trial Acronym |
ATTAIN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 105MS302, Protocol version 1.0 dated 18th May 2011 |
Protocol Number |
| 2010-024477-39 |
EudraCT |
|
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 UK,
Innovation House 70 Norden Road Maidenhead Berkshire
United Kingdom SL4 6AY |
|
|
Primary Sponsor
|
| Name |
Biogen Idec |
| Address |
Innovation House 70 Norden Road Maidenhead Berkshire SL4 6AY |
| Type of Sponsor |
Other [Biotech Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biogen Idec Biotech India Pvt Ltd |
Biogen Idec Biotech India Pvt Ltd 14th Floor Vatika Towers Golf Course Road Sector 54 Gurgaon Haryana India
|
|
|
Countries of Recruitment
|
Belgium
Bulgaria
Canada
Chile
Colombia
Croatia
Czech Republic
Estonia
France
Georgia
Germany
Greece
India
Latvia
Mexico
Netherlands
New Zealand
Peru
Poland
Russian Federation
Serbia
Spain
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalin Shah |
Neurology Center |
Neurology Center, Ahmedabad
Ahmadabad
GUJARAT |
9825465067
26405758
drshalinshah@yahoo.co.in |
| Dr Manjari Tripathi |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI |
911126588248
911126588166
ramesh_v003@hotmail.com |
| Dr Chandrashekhar Meshram |
Brain And Mind Institute |
Brain and Mind Institute Clinic, B-101, Neeti Gaurav Complex, Ramdespeth,-440010
Nagpur
MAHARASHTRA |
917122451626
drmeshram@hotmail.com |
| Dr Pawan Ojha |
Brain Centre |
Brain Center Clinic C2/6/0:3,Sector 2, Opp Abbott Hotel,-400703
Mumbai
MAHARASHTRA |
02227820818
ptojha@yahoo.co.in |
| Dr Manoj Gulhane |
Curie Manavata Cancer Centre |
Opposite Mahamarg Bus Stand, Mumbai, Naka- 422004
Nashik
MAHARASHTRA |
91-9822196080
mngulhane@hotmail.com |
| Dr Rahul Kulkarni |
Deenanath Mangeshkar Hospital and Research Centre |
Department of Neurology, Eradwane,-411004
Pune
MAHARASHTRA |
09822012588
rahulneuro@vsnl.net |
| Dr Sudhir Kothari |
Deprt of Neurology, Poona Hospital and Research Centre |
27 Sadashiv Peth,-411030
Pune
MAHARASHTRA |
09822719440
sudhirkothari@gmail.com |
| Dr Anshu Rohatgi |
Dept of Neurology, Sir Ganga Ram Hospital |
Old Rajinder Nagar,-110060
New Delhi
DELHI |
01142251439
rohatgianshu@yahoo.com |
| Dr Ratnavalli Ellajosyula |
Dept. of Neurology, Manipal Hospital |
98 Rustom Bagh, Airport Road,-560017
Bangalore
KARNATAKA |
08025023273
ratnavalli@yahoo.co.uk |
| Dr Pravar Passi |
Greater Kailash Hospital |
Department of Neurology,
11/2, Old Palasia,-452018
Indore
MADHYA PRADESH |
09826047847
pravarpassi@gmail.com |
| Dr Joy Desai |
Jaslok Hospital and Research Centre |
Clinical trial office, R. No-24, 2nd floor, Physiotherapy Dept.,Jaslok Hospital and Research Centre, 15, Dr. G. Deshmukh Marg,-400026
Mumbai
MAHARASHTRA |
02266573365
desaijoy@gmail.com |
| Dr Lekha Pandit |
Justice K. S. Hegde Charitable Hospital |
Department of Neurology,Deralakatte, Mangalore-575018
Bangalore
KARNATAKA |
09845084343
panditmng@gmail.com |
| Dr Prabhjeet Singh |
K D Hospital |
Department of Neurology7 Circular Road ,-143001
Amritsar
PUNJAB |
01832566737
drprabhjeet75@yahoo.co.in |
| Dr Krishnan Vijayan |
Kovai Medical Centre & Hospital |
Department of Neurology3209,Avanashi Road,-641014
Coimbatore
TAMIL NADU |
04224323202
kalyani_vijayan@rediffmail.com |
| Dr JD Mukherjee |
Max Superspeciality Hospital |
Department of Neurology,1,, Press Enclave Raod, Saket,-110017
New Delhi
DELHI |
01166116666
jd.mukherji@maxhealthcare.com |
| Dr Pahari Ghosh |
Sri Aurobindo Sevakendra |
Department of Neurology,1 H Gariahat Road,Jodhpur Park-700068
Kolkata
WEST BENGAL |
09831023296
pahari_ghosh@vsnl.net |
| Dr Sridharan Ramaratnam |
The Nerve Centre |
New 15,Old 25, Parthasarathypuram, T. Nagar,-600017
Chennai
TAMIL NADU |
09841098257
rsridharan52@gmail.com |
| Dr Shamsher Dwivedee |
Vidhya Sagar Institute of Mental Health and Neurosciences |
Department of Neurology, 1, Institutional Area,Nehru Nagar,-110065
New Delhi
DELHI |
09810084300
sdclinical@gmail.com |
| Dr Gurav Dave |
Well Care Hospital |
25-New Jagnath Road,Near Brahmakumari Temple-360001
Rajkot
GUJARAT |
09825328029
drdave.wellcare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Ethics Committee of Sri Aurobindo Seva Kendra |
Approved |
| Central Ethics Committee Mangalore |
Approved |
| Central India Medical Research Ethics Committee, used by Dr. Chandrashekhar Meshram, Brain and Mind Institute, Nagpur |
Approved |
| Cerebrovascular & Vasculitis Research Foundation Independent Ethics Committee, Chennai used by Dr. Sridharan |
Approved |
| Deenath Mangeshkar Hospital And Research Centre |
Approved |
| Ethics Committee - Sir Ganga Ram Hospital |
Approved |
| Ethics Committee Poona Hospital Research Centre |
Approved |
| Ethics Committee Vidyasagar Institute Of Mental Health And Neuro-Science |
Approved |
| Ethics Committee, Jaslok Hospital and Research Centre |
Approved |
| Greater Kailash Hospital Ethics Committe for human subject research |
Approved |
| Independent Ethics Committee used by Dr. Pawan Ojha, Brain Center, Mumbai |
Approved |
| Institutes Ethics Committee, AIIMS New Delhi |
Approved |
| Institutional Ethics Committee Manipal Hospital and Manipal Heart Foundation |
Approved |
| KMCH Ethics Committee |
Approved |
| Manavata Professional Ethics Committee, Curie Manavta Cancer, Centre |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| SAHEB Central Ethics Committee |
Approved |
| Sujalam Ethics Committee |
Approved |
| Wellcare Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Multiple Sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIIB 017 |
125 mcg BIIB017 SC every 2 weeks for 96 week Drug BIIB017 |
| Intervention |
BIIB017 |
125 mcg BIIB017 SC every 4 weeks for 96 weeks
Drug BIIB017 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information in
accordance with national and local subject privacy regulationsSubjects who participated in Study 105MS301 who completed the study treatment and
visit schedule through Week 96
Subjects of childbearing potential must practice effective contraception during the study
and be willing and able to continue contraception for 3 months after their last dose of
study treatment. |
|
| ExclusionCriteria |
| Details |
Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study
105MS301
Subjects with any significant change in medical history, including laboratory tests or a
current clinically significant condition that in the opinion of the Investigator would have
excluded the subject from participation in Study 105MS301. The Investigator must
re-review the subject�s medical fitness for participation and consider any factors that
would preclude treatment including
� Presence of any clinically significant as determined by the Investigator cardiac
endocrinologic hematologic hepatic immunologic metabolic urologic pulmonary
neurologic dermatologic psychiatric renal or other major disease that would preclude
participation in a clinical study
Presence of malignant disease, including solid tumors and hematologic malignancies
with the exception of basal cell and squamous cell carcinomas of the skin that have
been completely excised and are considered cured
Clinically significant laboratory abnormalities hematology and blood chemistry on
the most recently available test of Study 105MS301 as determined by the Investigator.
Laboratory findings mandating discontinuation of study treatment as defined in
protocol 105MS301 are exclusionary.
3. Female subjects who are currently pregnant as reflected by a positive pregnancy test at
the Week 96 Visit of Study 105MS301 Baseline Visit who are currently breastfeeding
or who are considering becoming pregnant while in the study
4. 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 subjects
ability to comply with the protocol.
Other unspecified reasons that in the opinion of the Investigator or Biogen Idec make
the subject unsuitable for enrollment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measures:
The incidence of adverse events and lab abnormalities as a measure of the long-term safety and tolerability of BIIB017 |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• MS outcomes assessed using the annualized relapse rate (ARR)
• MRI outcomes assessed using the number and volume of brain lesions [ Time Frame: 2 years ]
• Disability outcomes assessed using the Expanded Disability Status Score (EDSS) and Symbol Digit Modalities Test (SDMT) Quality of Life assessed using the SF-12, EQ-5D, and MSIS-29
|
Time Frame: 2 years |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
11/04/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="10"
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 is A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis.
The purpose of this Extension Study is to determine the long-term safety, tolerability, and MS outcomes of BIIB017 in subjects completing Study 105MS301 (ADVANCE).
Subjects will administer 125 mcg BIIB017 subcutaneously (SC) at 2 dose frequencies: every 2 weeks or every 4 weeks. In this extension study, subjects will continue to administer BIIB017 at the same dose regimen they were following during their participation in the second treatment year of Study 105MS301. |