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1 Clinical Trial Details (PDF Generation Date :- Sun, 18 Feb :17:30 GMT) CTRI Number CTRI/2010/091/ [Registered on: 09/09/2010] - Last Modified On 05/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Interventional Drug Randomized, Parallel Group, Active Controlled Trial Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon β 1a) in Patients with Relapsing-Remitting Multiple Sclerosis Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) EudraCT 205-MS-301 NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Shilpi Ray Phone Fax Designation Affiliation Biogen Idec Biotech Pvt. Ltd. Vatika Towers, B Block, 14th Floor, Sec 54, Golf Course Sector Road, Gurgaon HARYANA shilpi.ray@biogenidec.com Details Contact Person (Scientific Query) Dr. Anjali Nagpal Senior Advisor, Scientific Affairs Phone Fax Designation Affiliation Biogen Idec Biotech Pvt. Ltd Vatika Towers, B Block, 14th Floor, Sec 54, Golf Course Sector Road, Gurgaon HARYANA Haryana anjali.nagpal@biogenidec.com Details Contact Person (Public Query) Shilpi Ray Biogen Idec Biotech Pvt. Ltd. Vatika Towers, B Block, 14th Floor, Sec 54, Golf Course Sector Road, Gurgaon page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics HARYANA Phone Fax Source of Monetary or Material Support > Biogen Idec Innovation House 70 Norden Road Maidenhead Berkshire SL4 6AY, United Kingdom Type of Sponsor Nil List of Countries of Principal Investigator Primary Sponsor Details Biogen Idec Inc 14 Cambridge Center Cambridge, MA USA Pharmaceutical industry-global of Site Site Phone/Fax/ Dr. Sanjay Ramteke Jasleen Hospital Opp Big Bazaar,Pnachsheel Square Nagpur MAHARASHTRA Dr. R Srinivasa MS Ramiah Hospital New B E L Road,,M S Ramaiah Nagar, MSRIT Post, Bangalore KARNATAKA drrsrinivasa@hotmail.c om Dr. Neeta Mehta Neeta Mehta Clinic, D-502, 5th Floor, Rizvi Nagar, Milan Subway Junction, S.V. Road,, Mumbai MAHARASHTRA Dr. P. Satish Chandra Dr. AK Meena Dr. Roop Gursahani Dr. Muralidharan Nair NIMHANS Department of Neurosciences Nizams Institute of Medical Sciences PD Hinduja National Hospital and Medical Research Center Sree Chitra Tirunal Institute of Medical Science and Technology,- Not Applicable N/A Punjagutta, Hyderabad ANDHRA PRADESH V.S. Marg,Mahim Mumbai MAHARASHTRA Ganga Bhavan,General Post Office Lane Not Applicable N/A drneetamehta@gmail.c om akmeena@hotmail.com nairmuralidharan@yaho o.com of Approval Status Date of Approval Is Independent Ethics? Central Medical Approved 21/04/2010 No page 2 / 6

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Research Ethics Independant Ethics Institutional Ethics MSRMC Ethical Review Board NIMHANS Ethics P.D Hinduja National Hospital & Medical Research Centre, Clinical Research Ethics Sree Chitra Tirunal Institute of Medical Science and Technology Institutional Ethics Status Approved 04/06/2010 Yes Approved 26/07/2011 No Approved 31/08/2010 No Approved 29/10/2010 No Approved 09/06/2010 No Approved 18/11/2010 No Date Approved/Obtained 21/07/2010 Health Type Patients Condition Relapsing Remitting Multiple Sclerosis Type Details Intervention Daclizumab High Yield Process (DAC HYP) 150 mg sub-cutenous (SC) once every 4 weeks for 96 to 144 weeks Comparator Agent Avonex (IFN?-1a) 30 mcg intramuscular (IM) injection once weekly for 96 to 144 weeks Age From Age To Gender Details Inclusion Criteria Inclusion Criteria To be eligible for this study, candidates must meet the following eligibility criteria prior to randomization or at the timepoint specified in the individual criteria listed below: 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 18 to 55 years of age, inclusive, at the time of consent. 3. Must have a confirmed diagnosis of RRMS according to McDonald criteria, numbers 1 through 4 (Polman et al, 2005), and a cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to obtain a current scan if a scan performed previously is available; if a previous scan is not available, then the baseline scan may be used). 4. Must have a baseline EDSS between 0.0 and 5.0, inclusive. 5. Must meet one of the following disease activity-related criteria: a) Two or more clinical relapses within the previous 3 years with at least 1 clinical relapse in the 12 months prior to randomization. OR b) One or more clinical relapses and 1 or more new MRI lesions (Gd+ and/or T2 hyperintense lesion) within the previous 2 years with at least one of these events in the 12 months prior to randomization. The new MRI page 3 / 6

4 Exclusion Criteria Details lesion must be distinct from one associated with the clinical relapse. The baseline MRI may be used to satisfy this criterion. Note: For inclusion purposes, a clinical relapse is defined as neurologic signs and/or symptoms documented in the medical record of at least 24 hours duration that are determined by the Investigator or the Treating Neurologist as consistent with an MS relapse. Time since relapse should be measured from the time of relapse onset. When inclusion is based on a new MRI lesion, activity must be verified by the central MRI reading center. 6. Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment. Exclusion Criteria Exclusion Criteria Candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization or at the timepoint specified in the individual criteria listed below: Medical History 1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 2001). 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. Known intolerance, contraindication to, or history of non-compliance with Avonex 30 mcg. Note: Current or prior use of an approved IFN β preparation for MS, including Avonex, is allowed as long as the subject is currently appropriate for Avonex treatment according to local prescribing information. 3. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study. 4. History of severe allergic or anaphylactic reactions. 5. Known hypersensitivity to study drugs or their excipients. 6. History of abnormal laboratory results that, in the opinion of the Investigator, are indicative of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease that would preclude administration of DAC HYP or Avonex. 7. History of human immunodeficiency virus (HIV) or other immunodeficient conditions. 8. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization. 9. History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline. 10. History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1. Subjects receiving ongoing antidepressant therapy will not be excluded from the study unless the medication has been increased within the 6 months prior to Baseline. 11. 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. 12. Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus. 13. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening. 14. Exposure to varicella zoster virus within 21 days before screening. 15. Any of the following abnormal blood tests at screening:? hemoglobin 9.0 g/dl? platelets 100 x 109/L? lymphocytes 1.0 x 109/L? neutrophils 1.5 x 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 page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant, Investigator and Outcome Assessor Blinded upper limit of normal (ULN)? serum creatinine ULN Treatment History 16. Any previous treatment with daclizumab or other anti-cd25 monoclonal antibody. 17. Any type of live virus vaccine from 4 weeks before randomization, including but not limited to, measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine. 18. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV) antibiotics within 8 weeks before randomization. 19. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study. 20. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization. 21. Prior treatment with the any of the following:? total lymphoid irradiation? cladribine? T cell or T cell receptor vaccination? any therapeutic monoclonal antibody, except natalizumab 22. Prior treatment with mitoxantrone, cyclophosphamide, fingolimod, or natalizumab within 1 year prior to randomization. 23. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:? cyclosporine? azathioprine? methotrexate? mycophenolate mofetil? intravenous immunoglobulin? plasmapheresis or cytapheresis. 24. Treatment with any of the following medications within the 30 days prior to randomization:? IV corticosteroid treatment? oral corticosteroid treatment? glatiramer acetate Note: Subjects who are currently receiving an approved IFN β preparation are not required to washout from IFN β prior to randomization, but IFN β treatment must be discontinued prior to randomization. 25. Initiation of treatment or dose adjustment of commercially-available Fampridine-SR within the last 90 days. Note: Subjects who have been on a stable dose of commercially-available Fampridine-SR for longer than 90 days are not excluded. Use of compounded or other formulations of 4-aminiopyridine is excluded. Miscellaneous 26. Female subjects who are currently pregnant or breastfeeding. 27. Female subjects considering becoming pregnant while in the study. 28. Previous participation in this study. 29. Subjects for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed. 30. 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. 31. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment. Primary Outcome Outcome Timepoints Annualized relapse rate (ARR) 96 weeks Secondary Outcome Outcome Timepoints The secondary endpoints (rank ordered) for this study are: 1) Number of new or newly-enlarging T2 hyperintense lesions on brain MRI over 96 weeks 2) Change in Multiple Sclerosis Functional Composite (MSFC) score 3) Sustained disability progression defined by at least a 1.0-point increase on EDSS from baseline EDSS 1.0 that is sustained for 96 weeks page 5 / 6

6 Powered by TCPDF ( REFCTRI/2010/ Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 12 weeks or at least a 1.5-point increase on the EDSS from baseline EDSS <1.0 that is sustained for 12 weeks 4) Change in Multiple Sclerosis Impact Scale 29 (MSIS-29) physical score 5) The proportion of subjects who are relapse-free Total Sample Size=1500 Sample Size from =50 No Date Specified 30/09/2010 Years=3 Months=0 Days=0 Completed Completed This is a multicentric global trial with a sample size of 1500 patients The primary study objective is to test the superiority of DAC HYP compared to IFN-b-1a in preventing MS relapse in subjects with RRMS. We have obtained approval to recruit upto 50 patients in and the anticipated date to start recruitment in is as on 30-Sep page 6 / 6