| CTRI Number |
CTRI/2010/091/001093 [Registered on: 20/10/2010] |
| Last Modified On: |
21/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
To evaluate the safety and efficacy of DAC HYP in subjects with Multiple Sclerosis who have completed treatment in study 205MS201 (SELECT). |
|
Scientific Title of Study
|
A double blind, multi center, extension study to evaluate the safety and efficacy of DAC HYP in subjects with Multiple Sclerosis who have completed treatment in study 205MS201 (SELECT).
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2008-005559-46 |
EudraCT |
| 205MS202 |
Protocol Number |
| NCT00870740 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Nitya Pandita |
| Designation |
Clinical Trial Lead |
| Affiliation |
|
| Address |
Biogen Idec Biotech India Pvt. Ltd.
Vatika Towers, B Block, 12th Floor, Sec 54, Golf Course Road
Gurgaon
HARYANA
122002
India |
| Phone |
01244572349 |
| Fax |
911244572370 |
| Email |
nitya.pandita@biogenidec.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anjali Nagpal |
| Designation |
|
| Affiliation |
Senior Scientific Advisor |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
Vatika Towers, B Block, 14th Floor, Sec - 54, Golf Course Road
Gurgaon
HARYANA
122002
India |
| Phone |
01244572343 |
| Fax |
01244572370 |
| Email |
anjali.nagpal@biogenidec.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nitya Pandita |
| Designation |
Clinical Trial Lead |
| Affiliation |
|
| Address |
Biogen Idec Biotech India Pvt. Ltd.
Vatika Towers, B Block, 12th Floor, Sec 54, Golf Course Road,
Gurgaon
HARYANA
122002
India |
| Phone |
01244572349 |
| Fax |
01244572370 |
| Email |
nitya.pandita@biogenidec.com |
|
|
Source of Monetary or Material Support
|
| Biogen Idec Innovation House 70 Norden Road, Maidenhead Berkshire SL4 6A |
|
|
Primary Sponsor
|
| Name |
Biogen Idec |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. R.R. Agrawal |
Fortis Escorts Hospital |
Jawahar Lal Nehru Marg ,Malviya Nagar ,-302 017
Jaipur
RAJASTHAN |
drrajaram195@rediffmail.com |
| Dr. K. Venkateswarlu |
King George Hospital |
Dept. of Neurology,Rajendra Prasad Ward,-530002
|
mythmedi@satyam.net.in |
| Dr. A.K. Meena |
Nizam's Institute of Medical Sciences |
Department of Neurology, Panjagutta ,-500082
Hyderabad
ANDHRA PRADESH |
meenaak@hotmail.com |
| Dr. Pahari Ghosh |
Sri Aurobindo Seva Kendra, Department of Neurology, |
1-H Gariahat Road (South),-700068
Kolkata
WEST BENGAL |
pahari_ghosh@vsnl.net |
| Dr. A.K. Roy |
St Johns Medicial Hospital |
Department of Neurology Kormangala ,-560034
Bangalore
KARNATAKA |
royajit@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee of Sri Aurobindo Seva Kendra Address: Sri Aurobindo Seva Kendra, 1H Gariahat Road (South), Jodhpur Park, Kolkata-700068, India |
Approved |
| Institutional Ethical Review Board- St.Johns Medical College & Hospital Address: Sarjapur Road, Banglore-560034, India |
Approved |
| Institutional Ethics Committee, Fortis Escorts Hospital Address: Jawaharlal Nehru Marg, Malviya Nagar, Jaipur -302017, India |
Approved |
| Institutional Ethics Committee- Nizams Institute of Medical Sciences Address: Panjagutta, Hyderabad-500082, India |
Approved |
| Institutional Ethics Committee-Andhra Medical College Address: Andra Medical College, King George Hospital,Visakhapatnam-530002, India |
Approved |
| Seth G S Medical College & KEM Hospital, Ward No 223/224/226, 2nd floor, Old building, Acharya Dhonde Marg, Parel, Mumbai-400012, India |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Relapsing Remitting Multiple Sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAC HYP |
a) DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.b) DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.c) Placebo SC every 4 weeks for a total of 5 doses followed by
DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.d) DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.e)Placebo SC every 4 weeks for a total of 5 doses followed by
DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.f) DAC HYP 300 mg SC every 4 weeks for a total of 13 doses. |
| Comparator Agent |
NIL |
There is no control intervention in the trial. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 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 protected health information (PHI) in
accordance with national and local subject privacy regulations.
2. Must be a subject from Study 205MS201 for at least 52 weeks and must have been
compliant with the 205MS201 protocol in the opinion of the Investigator.
3. All male subjects and female subjects 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. For further details
of contraceptive requirements for this study |
|
| ExclusionCriteria |
| Details |
1. Subjects with any significant change in their medical status from Study 205MS201
that would preclude administration of DAC HYP including laboratory results or a
current clinically-significant condition that, in the opinion of the Investigator, would
have excluded the subject?s participation in Study 205MS201. The Investigator must
re-review the subject?s medical fitness for participation and must consider any
diseases that would preclude treatment with DAC HYP.
2. Any subject who has permanently discontinued study treatment in Study 205MS201
except subjects who were unblinded during evaluation of an adverse event (AE) and
found to be on placebo.
3. Planned ongoing treatment with any approved or experimental treatment for MS
except for the protocol-allowed use of concomitant IFN-beta.
4. Current enrollment in any investigational drug study other than 205MS201.
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.
6. Other unspecified reasons that, in the opinion of the Investigator or the Biogen Idec
Medical Director, make the subject unsuitable for enrollment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who have completed 52 weeks of active therapy with DAC HYP in Study 205MS201. 2. An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. 3. An assessment of safety and immunogenicity during re-initiation of therapy with DAC HYP after a 6-month washout period. 4. An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during study 205MS201 |
After the patient completes week 52 in study 205MS201 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses. |
After the patient completes week 52 in study 205MS201. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="600"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
13/02/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
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
|
The rationale of this study is to extend DAC HYP therapy from study 205MS201 in order to evaluate the long term safety, efficacy and immunogenicity of DAC HYP in multiple sclerosis.
Globally as of date, 221 patients have been rolled into this extension study out of the 621 patients who had been randomized in 205MS201 (SELECT) study. The first patient in India is expected to be Jan 2011. Approximately 20 patients are expected to be recruited in India. The first patient is expected to be enrolled in the study in India is by Jan 2011. The enrollment period in India will be from Jan 2011 to April 2012. |