| CTRI Number |
CTRI/2010/091/000773 [Registered on: 18/03/2010] |
| Last Modified On: |
27/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The purpose of this study is to determine the effect of 2 different doses of daclizumab on reducing relapses in subjects with relapsing-remitting MS. |
|
Scientific Title of Study
|
A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to determine the Safety and Efficacy of Dacluzimab HYP (DAC HYP) as a Monotherapy Treatment in subjects with Relapsing Remitting Multiple Sclerosis.
Acronym: SELECT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2006-001161-42 |
EudraCT |
| 205-MS-201 |
Protocol Number |
| NCT00390221 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Nitya Pandita |
| Designation |
Sr. Clinical Trial Lead |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
Vatika Professional Point,
12th Floor,
Golf Course Extension Road, Badshahpur, Sector-66
Gurgaon
HARYANA
122001
India |
| Phone |
01244572349 |
| Fax |
01244572333 |
| Email |
nitya.pandita@biogenidec.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anjali Nagpal |
| Designation |
Head - Medical Affairs |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
Vatika Professional Point,
12th Floor,
Golf Course Extension Road,
Badshahpur, Sector-66
Gurgaon
HARYANA
122001
India |
| Phone |
01244572343 |
| Fax |
01244572333 |
| Email |
anjali.nagpal@biogenidec.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nitya Pandita |
| Designation |
Sr. Clinical Trial Lead |
| Affiliation |
Biogen Idec Biotech India Pvt. Ltd. |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
Vatika Professional Point,
12th Floor,
Golf Course Extension Road,
Badshahpur, Sector-66
Gurgaon
HARYANA
122001
India |
| Phone |
01244572349 |
| Fax |
01244572333 |
| Email |
nitya.pandita@biogenidec.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Biogen Idec,
Innovation House,
70 Norden Road,
Maidenhead,
Berkshire,
SL4 6AY |
|
Primary Sponsor
Modification(s)
|
| Name |
Biogen Idec |
| Address |
Biogen Idec, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL4 6AY |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajaram Agrawal |
Fortis Escort Hospital |
Malviya Nagar ,-302017
Jaipur
RAJASTHAN |
+91.141.254.7000
+91.141.400.8151
drrajaram195@rediffmail.com |
| Dr. Kolichana Venkateshwarlu |
King George Hospital |
Dept. of Neurology, Rajendra Prasad Ward,-530002
|
|
| Dr. A. K. Meena |
Nizams Institute of Medical Sciences |
Panjagutta,-500082
Hyderabad
ANDHRA PRADESH |
+91.40.664.61365
+91.40.664.61365
nimsneurostudies@gmail.com |
| Dr. Vivek Jain/ Dr. Neeraj Jain |
Seth GSMC & KEM Hospital |
Acharya Dhonde Marg, Parel,-4000l2
Mumbai
MAHARASHTRA |
+91.932.086.5123
+91.22.241.64206
drvivek_jain@yahoo.co.in |
| Dr. Pahari Ghosh |
Sri Aurobindo Seva Kendra |
1H Gariahat Road (South), Jodhpur Park,-700068
Kolkata
WEST BENGAL |
91.983.102.3296
91.33.249.90059
pahari_ghosh@vsnl.net |
| Dr. A. K. Roy |
St. John's Medical College Hospital |
Dept. of Neurology, Kormangala,-560034
Bangalore
KARNATAKA |
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects , Address: Seth G. S. Medical College & K.E.M. Hospital, Parel, Mumbai-4000l2, India |
Approved |
| Ethics Committee of Sri Aurobindo Seva Kendra Address: Sri Aurobindo Seva Kendra, 1H Gariahat Road (South), Jodhpur Park, Kolkata-700068, India |
Approved |
| Ethics Committee-Andhra Medical College Address: Andra Medical College, King George Hospital,Visakhapatnam-530002, 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 |
| Name: Institutional Ethics Committee- Nizams Institute of Medical Sciences Address: Panjagutta, Hyderabad-500082, India |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Relapsing Remitting Multiple Sclerosis (RRMS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Daclizumab HYP |
150mg SC Inj. every 4wk |
| Intervention |
Daclizumab HYP |
300mg SC Inj. every 4wk |
| Comparator Agent |
Placebo |
to match |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:
a. Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR
b. Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
|
|
| ExclusionCriteria |
| Details |
Candidates will be excluded from study entry if any of the following exclusion criteria exist
at the time of randomization:
Medical History
1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
(as defined Lublin and Reingold, 1996 [Section 23]). These conditions require the
presence of continuous clinical disease worsening over a period of at least 3 months.
Patients with these conditions may also have superimposed relapses, but are
distinguished from relapsing-remitting patients by the lack of clinically stable periods or
clinical improvement.
2. History of malignancy; however, subjects with a history of excised or treated basal cell
carcinoma or fewer than 3 squamous sell carcinomas are eligible to participate in this
study.
3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
4. History of abnormal laboratory results that, in the opinion of the investigator, are
indicative of any significant cardiac, endocrinologic, hematologic, hepatic,
immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic,
psychiatric, renal, neurologic (other than MS), and/or other major disease that would
preclude administration of DAC HYP.
5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.
6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior
to randomization.
7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the
subject has not stabilized from a previous relapse prior to randomization.
8. Positive screening for active infection with Hepatitis B virus or Hepatitis C virus.
9. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks
before Screening.
10. Exposure to varicella zoster virus within 21 days before Screening.
11. Any of the following abnormal blood tests at Screening:
? Hemoglobin ≤9.0 g/dL
? Platelets ≤100 × 109/L
? Lymphocytes ≤1.0 × 109/L
? Neutrophils ≤1.5 × 109/L
? alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT),
aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT),
or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN)
? serum creatinine >ULN.
Treatment History
12. Any previous treatment with DAC HYP or Zenapax®
.
13. Any of the following types of live virus vaccine from 4 weeks before randomization:
measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and
nasal influenza vaccine. Use of these vaccines, however, by other members of the
subject?s household does not affect the eligibility of subjects to enroll or continue in the
study.
14. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV)
antibiotics within 8 weeks before randomization.
15. Elective surgery performed from 2 weeks prior to randomization or scheduled through
the end of the study.
16. Prior treatment with the any of the following:
? total lymphoid irradiation
? cladribine
? mitoxantrone
? T-cell or T-cell receptor vaccination
? any therapeutic monoclonal antibody, except natalizumab or rituximab.
17. Prior treatment with cyclophosphamide or rituximab within 1 year prior to
randomization.
18. Prior treatment with any of the following medications or procedures within the 6 months
prior to randomization:
? natalizumab
? cyclosporine
? azathioprine
? methotrexate
? intravenous immunoglobulin (IVIg)
? plasmapheresis or cytapheresis.
19. Prior treatment with any of the following within the 3 months prior to randomization:
? SC or oral glatiramer acetate
? IFN-alpha
? IFN-beta (subjects who are positive for neutralizing antibodies to IFN-beta may
receive IFN-beta treatment up to 2 weeks prior to randomization).
20. Treatment with any of the following steroids/ 4-aminopyridine products within the 30 days prior to
randomization |
|
|
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 |
| Annualised relapse rate |
Week 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a. Brain MRI measures (number of gd enhancing lesions, number of new or newly enlarging T2 hyperintense lesions
b. Proportion of relapsing subjects
c. Improving quality of life |
Week 52 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="600"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
04/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/02/2008 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52.
We have approval to recruit up to 60 patients in India and the anticipated date to start recruitment in India will for 13 Oct 2009.
Update:The screening was stopped in the study in Apr 2010 as the target number of patients was achieved. |