| CTRI Number |
CTRI/2009/091/000690 [Registered on: 12/10/2009] |
| Last Modified On: |
18/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To determine if treatment with BIIB017 can decrease the number of MS relapses during a certain time period for patients with RMS. Other goals of the study are to determine if, over time, BIIB017 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis.
Acronym: ADVANCE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 105MS301 |
Protocol Number |
| 2008-006333-27 |
EudraCT |
| NCT00906399 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mamta Madaan |
| Designation |
Senior Clinical Trial Lead |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
14th floor, Vatika Towers B, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4572314 |
| Fax |
0124-4572333 |
| Email |
mamta.madaan@biogenidec.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anjali Nagpal |
| Designation |
Medical Affairs Country Head |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
12th floor, Vatika Towers B, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4572304 |
| Fax |
0124-4572333 |
| Email |
anjali.nagpal@biogenidec.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mamta Madaan |
| Designation |
Clinical Reseach Country Head |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
14th floor, Vatika Towers B, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4572341 |
| Fax |
0124-4572333 |
| Email |
mamta.madaan@biogenidec.com |
|
|
Source of Monetary or Material Support
|
| Biogen Idec
Innovation House
70 Norden Road
Maidenhead
Berkshire
SL4 6AY |
|
Primary Sponsor
Modification(s)
|
| Name |
Biogen Idec |
| Address |
Innovation House 70 Norden Road Maidenhead, Berkshire United Kingdom SL6 4AY |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 21 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjari Tripathi |
All India Institute of Medical Sciences |
Department of Neurology,AIIMS, Ansari Nagar, New Delhi 1
South
DELHI |
01126588248
01126588166
manjari.tripathi@gmail.com |
| Dr Vardharjulu |
Bangalore Clinisearch |
No:416, 4th cross, 2nd block,Kalyan Nagar
Bangalore
KARNATAKA |
9916512825
80-25459006
gowrisankarcr@gmail.com |
| Dr Chandrashekhar Meshram |
Brain And Mind Institute |
B-101, Neeti Gaurav Complex, Ramdespeth
Nagpur
MAHARASHTRA |
0712-2451626
0712-2451626
drmeshram@hotmail.com |
| Dr Pawan Ojha |
Brain Centre |
C2/6/0:3,Sector 2, Opp Abbott Hotel
Mumbai
MAHARASHTRA |
022-27820818
022-27822468
ptojha@yahoo.co.in |
| Dr Joy Desai |
Clinical trial office, R. No-24, 2nd floor, Physiotherapy Dept.,Jaslok Hospital and Research Centre |
15, Dr. G. Deshmukh Marg
Mumbai
MAHARASHTRA |
022-66573365
022-23526282
desaijoy@gmail.com |
| Dr Manoj Gulhane |
Curie Manavata Cancer Centre |
Opposite Mahamarg Bus Stand, Mumbai Naka
Nashik
MAHARASHTRA |
9822196080
02532594866
mngulhane@hotmail.com |
| Dr Rahul Kulkami |
Deenanath Mangeshkar Hospital and Research Centre |
Department of Neurology Eradwane
Pune
MAHARASHTRA |
9822012588
020-66023012
rahulneuro@vsnl.net |
| Dr Sudhir Kothari |
Deprt of Neurology, Poona Hospital and Research Centre |
27 Sadashiv Peth
Pune
MAHARASHTRA |
9822719440
020-24320681
sudhirkothari@gmail.com |
| Dr Anshu Rohatgi |
Dept of Neurology, Sir Ganga Ram Hospital |
Old Rajinder Nagar
New Delhi
DELHI |
011-42251439
011-45041726
rohatgianshu@yahoo.com |
| Dr Ratnavalli Ellajosyula |
Dept. of Neurology, Manipal Hospital |
98 Rustom Bagh, Airport Road
Bangalore
KARNATAKA |
080-25023273
080-25207181
ratnavalli@yahoo.co.uk |
| Dr Pravar Passi |
Greater Kailash Hospital |
11/2, Old Palasia,
Indore
MADHYA PRADESH |
09826047847
0-7314043923
pravarpassi@gmail.com |
| Dr Lekha Pandit |
Justice K. S. Hegde Charitable Hospital |
Department of Neurology,Deralakatte
Bangalore
KARNATAKA |
09845084343
08242203747
panditmng@gmail.com |
| Dr Prabhjeet Singh |
K D Hospital |
7 Circular Road ,
Amritsar
PUNJAB |
0183-2566737
01832220795
drprabhjeet75@yahoo.co.in |
| Dr Krishnan Vijayan |
Kovai Medical Centre & Hospital |
Department of Neurology,3209,Avanashi Road
Coimbatore
TAMIL NADU |
04224323202
04222627782
kalyani_vijayan@rediffmail.com |
| Dr J D Mukherji |
Max Superspeciality Hospital |
Department of Neurology,1, Press Enclave Raod, Saket
New Delhi
DELHI |
011-66113073
011-26514040
jd.mukherji@maxhealthcare.com |
| Dr Shalin Shah |
Neurology Centre |
206-7-8 Sangini Complex,Near Parimal Crossing,Ellisbridge
Ahmadabad
GUJARAT |
09825465067
07926405758
drshalinshah@yahoo.co.in |
| Dr Bhawna Sharma |
Sawai Man Singh Hospital |
Department of Neurology, Jawaharlal Nehru Marg,
Jaipur
RAJASTHAN |
09829219314
01412561286
sharmadrbhawna@gmail.com |
| Dr Pahari Ghosh |
Sri Aurobindo Sevakendra |
1 H Gariahat Road,Jodhpur Park-700068
Kolkata
WEST BENGAL |
09831023296
033-24990059
pahari_ghosh@vsnl.net |
| Dr Sridharan Ramaratnam |
The Nerve Centre |
New 15,Old 25, Parthasarathypuram,T. Nagar
Chennai
TAMIL NADU |
09841098257
044-28143365
rsridharan52@gmail.com |
| Dr Shamsher Dwivedee |
Vidhya Sagar Institute of Mental Health and Neurosciences |
1, Institutional Area,Nehru Nagar
New Delhi
DELHI |
09810084300
01129849036
sdclinical@gmail.com |
| Dr Gurav Dave |
Well Care Hospital |
25-New Jagnath Road,Near Brahmakumari Temple
Rajkot
GUJARAT |
09825328029
0281-2468684
drdave.wellcare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 21 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Central Ethics Committee Mangalore |
Approved |
| Central India Medical Research Ethics Committee Nagpur |
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 |
| Ethics Committee, SMS Medical College and attached Hospital, Jaipure |
Approved |
| Greater Kailash Hospital Ethics Committe for human subject research |
Approved |
| independent Ethics Committee for Research on human subjects used by Dr. Sridharan, Chennai |
Approved |
| Independent Ethics Committee of Sri Aurobindo Seva Kendra |
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 |
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
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Relapsing Multiple Sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIIB017 |
125 mcg BIIB017 SC every 2 weeks for 96 weeks |
| Intervention |
BIIB017 |
125 mcg BIIB017 SC every 4 weeks for 96 weeks |
| Comparator Agent |
Placebo |
SC Placebo every 2 weeks for 48 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
1. Aged 18 to 65 years old, inclusive, at the time of informed consent.
2. Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4.
3. Must have an EDSS score between 0.0 and 5.0.
4. Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months. |
|
| ExclusionCriteria |
| Details |
1. Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
2. Pregnant or nursing women
Other protocol-defined, Inclusion/ exclusion criteria may apply. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability. |
1 year |
|
Target Sample Size
Modification(s)
|
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)
Modification(s)
|
11/12/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/05/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a multicenter, randomized, double-blind, parallel- group, placebo- controlled study to evaluate the efficacy and safety of PEGylated Interferon Beta-1a (BIIB017) (125 mcg SC) in two dosing frequencies (every 2 weeks and every 4 weeks) in subjects with relapsing multiple sclerosis. The study will be conducted in approximately 30 countries and approximately 225 sites globally. Approximately 1260 subjects are planned to participate in this trial. The primary outcome measure is to determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo. The secondary outcomes are to determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability. India has contributed 170 patients and all the patients are in the follow up phase of the study. |