PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sat, 05 Jan :03:49 GMT) CTRI Number Last Modified On 01/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/09/ [Registered on: 29/09/2011] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Active Controlled Trial Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis (FIXTURE) A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis 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) CAIN457A2303 NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Murugananthan K Head-Clinical Development Phone Fax Designation Affiliation Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, India murugananthan.k@novartis.com Details Contact Person (Scientific Query) Murugananthan K HCD Phone Fax Designation Affiliation Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, India murugananthan.k@novartis.com Details Contact Person (Public Query) Murugananthan K HCD Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax > Novartis Pharma AG,Basel,Switzerland Type of Sponsor NIL List of Countries Belgium Germany Guatemala Iceland Italy Poland Russian Federation United States of America of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Novartis Healthcare Pvt Ltd Medical Dept, Sandoz House, Shiv Sagar Estate, Dr.A.B. road, Worli, Pharmaceutical industry-global of Site Site Phone/Fax/ Dr Mir Mubashir Cuticare centre Cuticare centre, #9-4-86/288/1/A, 1st floor, Above swift car decors, Beside Reebok showroom, Salarjung colony, Tolichowki, Dr Sharmila Patil D.Y.Patil Medical college and Hospital D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD, Sector-5, Nerul, Navi , Maharashtra Dr D G Saple Dr Saples Clinic Hindu Colony, Lane no 3,Near Bhagini Samaj, Dadar (east) mumbai - Dr D V S Pratap Durgabai Deshmukh hospital & Research Centre Durgabai Deshmukh hospital & Research Centre, Research Room, 1st floor, OP dr_mirs@hotmail.com drsharmilapatil@gmail.c om sapleclinic@gmail.com pratap_dvs@yahoo.co.i n page 2 / 7

3 Dr Ramesh Bhat Dr M G Gopal Father Muller Medical College Hospital Kempegowda Institute of Medical Sciences block, University road, Vidyanagar, Father muller road, Kankanady, Mangalore Kempegowda Institute of Medical Sciences, Skin Department of Skin, No: 10, KIMS hospital, KR Road, VV Puram, rameshderma@yahoo.c om gopalamg@yahoo.co.in Dr B V Rama Chandra King George Hospital Department of Dermatology,Near Colle ctorate,maharanipet, bvrderma@gmail.com Visakhapatnam Visakhapatnam Dr Rachita Dhurat Dr B Leelavathy Dr Putta Srinivas Lokmanya Tilak Municipal Medical College & General Hospital M S Diabetes and Shridi Skin care centre Osmania General hospital Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion,,, Maharashtra No. 6/1, Poo. Krishna Sagar Hotel, 80 Feet Road, Indiranagar, Department of Dermatology, OP building, 1st floor, Osmania General hospital, Afzalgunj, Dr Sandesh Gupta Skin N Laser Center F10/9, Krishna Nagar, East Delhi, Delhi East DELHI Dr Sushil Y Pande Sparsh Hospital and Poly clinic 78 OM, Sri sai apartment, Vidyavihar,,Pratapnagar, Ring road,nagpur rachitadhurat@yahoo.c o.in drleelaskincare@rediff mail.com puttasrinivasderma@g mail.com drsandeshg@rediffmail. com drsushilpande@gmail.c om page 3 / 7

4 Details of Ethics Committee Regulatory Clearance Status from DCGI Dr Sacchidanand Sarvajanamurthy Aradhya Victoria Hospital Nagpur Professor, Department of Dermatology, Room Number 52,1st Floor, OPD building, Victoria Hospital, Fort, sacchi1260@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Clinical Ethics Forum,Dr. D G Saple Clinic CLINICOM,, Dr B Leelavathy CLINICOM,, Dr Mir Mubashir Ali Clinicom,, Dr. Sandesh Gupta Ethics Committe-Lokmanya Tilak Municipal Medical College Ethics Committtee, BMCRI Father Muller Institutional Ethics Committee, Father Muller Medical College Hospital Central Ethics Committee,, Dr D V S Pratap Independent Ethics committee Nagpur, Dr Sushil Pande Instituional Ethics Committee,D.Y.Patil Medical college and Hospital & research centre Institutional Ethics Committee, King George Hospital KIMS Ethics committee, KIMS Approved 13/12/2011 No Approved 14/10/2011 Yes Approved 01/07/2011 Yes Approved 21/10/2011 Yes Approved 01/02/2012 No Approved 10/02/2012 No Approved 24/06/2011 No Approved 09/09/2011 Yes Approved 10/09/2011 Yes Approved 11/11/2011 No Approved 20/07/2011 No Approved 09/08/2011 No Osmania Medical college ethics committe, Osmania Medical College Approved 26/11/2011 No Status Date Approved/Obtained 16/09/2011 page 4 / 7

5 Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Health Type Patients Condition Chronic Plaque Psoriasis Type Details Intervention secukinumab 300 mg and secukinumab placebo secukinumab 300 mg (two s.c. injections of the 150 mg dose) administered sub cutaneously till 48weeks. secukinumab placebo- (two sub cutaneous injections per dose) administered at Weeks 13, 14, and 15. Comparator Agent Etanercept -50mg etanercept 50 mg twice per week given sub-cutaneously for 51 weeks Intervention Secukinumab 150 mg and secukinumab placebo secukinumab 150 mg (one s.c. injection of the 150 mg dose + one s.c. injection of secukinumab placebo) administered till 48 weeks. secukinumab placebo (two s.c. injections per dose) administered at Weeks 13, 14 and 15. Comparator Agent Placebo group matching with Secukinumab 150mg Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Patients with Behts disease and with a history of recurrent uveitis in a least one eye. Documented evidence of Greater than22 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening). Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients patients medical record for each recurrent exacerbation: Greater than 2 plus vitreous haze with less than 2plus anterior chamber cell grade (intermediate or posterior uveitis) or Greater than22 plus vitreous haze with Greater than22 plus anterior chamber cell grade (panuveitis) presence of retinal infiltrates or vasculitis or hemorrhages documented Greater than210 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behts disease. Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behts disease: Prednisone or equivalent Greater than210 mg daily The need for at least Greater than21 periocular injection or Greater than21 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening) Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as page 5 / 7

6 monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.) Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator. Exclusion Criteria Details Exclusion Criteria Subjects with infectious uveitis, uveitis due to other causes than Behts disease, or uveitis of unknown etiology. Less severe (i.e. anterior) uveitis associated with Behts disease. Ocular treatments Treatment with intravitreal anti-vegf agents administered to the study eye within 3 months prior to study screening. Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert) in the study eye within the last 3 years. Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle Systemic conditions or treatments Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening. Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457. Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil). Chest X-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening, and evaluated by a qualified physician Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Other Double Blind Double Dummy Primary Outcome Outcome Timepoints Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI (psoriasis area and severity index) and IGA (investigators global assessment) Time Frame: 12 wks Secondary Outcome Outcome Timepoints 1.To determine if AIN457 can reduce the need for standard-of-care immuno suppressivemedications(ism) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçets disease as measured by the ISM score 1.Time Frame: 24 weeks page 6 / 7

7 Powered by TCPDF ( PDF of Trial Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Total Sample Size=1264 Sample Size from India=120 30/09/ /09/2009 Years=1 Months=6 Days=0 Completed Completed No publications provided Purpose of the study: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis. FPFV for India:30- Sep-2011 Enrolment target for India:120 page 7 / 7