Clinical Trial Details (PDF Generation Date :- Sun, 07 Oct 2018 22:54:26 GMT) CTRI Number Last Modified On 11/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/04/004518 [Registered on: 02/04/2014] - Trial Registered Retrospectively No Interventional Biological Randomized, Parallel Group, Placebo Controlled Trial To assess long term efficacy, safety, tolerability and usability of Secukinumab in patients with active Rheumatid Artheritis A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-tnf? agents Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) CAIN457F2311 V00 dated 07-Jun-12 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Murugananthan K Head-Clinical Development Phone 022-24958545 Fax Email Designation Affiliation Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate Dr. Annie Besant Road, Worli, Mumbai Mumbai 400018 murugananthan.k@novartis.com Details Contact Person (Public Query) Murugananthan K Head-Clinical Development Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate Dr. Annie Besant Road, Worli, Mumbai 400018 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 022-24958545 Fax Email > Novartis Pharma AG, Basel, Switzerland Type of Sponsor NIL List of Countries Argentina Brazil Colombia Czech Republic Dominican Republic Ecuador Germany Greece Guatemala Italy Panama Portugal Republic of Korea South Africa United States of America of Principal Investigator Dr Ajit Nalawade DrSarathchandra Mouli Veeravalli Dr Rajiv Gupta murugananthan.k@novartis.com Source of Monetary or Material Support Primary Sponsor Details Novartis Healthcare Pvt Ltd Medical Dept, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai- 400018 Pharmaceutical industry-global of Site Site Phone/Fax/Email Inamdar Multispecialty Hospital Krishna Institute of Medical Sciences Malpani Multispeciality Hospital Department of 020-41236660 Rheumatology, Inamdar Multispecialty Hospital dr.ajitnalawade@gmail. & Research Center, Sr. com No. 15, Fatimanagar, Behind KPCT Mall, Pune 411 040. Pune Deaprtment of Rheumatology,Krishna Institute of Medical Sciences,1-8-31/1, Minister Road, Secunderabad Hyderabad ANDHRA PRADESH Deaprtment of Rheumatology, Malpani Multispeciality 9866000685 sarath10@hotmail.com 9460891205 rajiv-jpr@indiatimes.co page 2 / 6
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr Girish Bhatia Dr Atul Kakar Medipoint Hospitals Pvt. Ltd Sir Ganga Ram Hospital Hospital,VKI,Sikar Road, Jaipur Jaipur RAJASTHAN Department of Rheumat ology,medipoint Hospitals Pvt. Ltd,241/1, New D. P. road, Aundh Pune Department of Rheumatology,Sir Ganga Ram Hospital Marg, Old Rajinder Nagar New Delhi DELHI DrSarvajeet Pal Sumana Hospital Department of rheumatology,sumana Hospital,Plot No 687,688, Vivekananda NagarColony,Kukatpall y, Hyderabad-500072 Hyderabad ANDHRA PRADESH m 7387003636 drbhatia.pentagon@gm ail.com 9811110802 atulkakar@hotmail.com 9848091533 palsarvajeet@yahoo.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethical Committee Inamdar Multispeciality Hospital, Dr Ajit Nalawade, Inamdar Multispeciality Hospital ETHICS COMMITTEE,SIR GANGA RAM HOSPITAL, Dr Atul Kakar Institutional Ethics Committee, Jaipur, Dr Rajiv Gupta Institutional Ethics Committee, KIMS, Veeravali Penta-Med Ethics Committee, Pune, Dr Girish Bhatia Sumana Hospital Ethics Committee Status Approved 17/02/2014 No Approved 15/03/2014 No Approved 28/07/2013 No Approved 28/01/2013 No Approved 24/12/2012 No Approved 11/01/2014 No Date Approved/Obtained 31/01/2014 Health Type Patients Condition Active Rheumatoid arthritis Type Details Intervention secukinumab (AIN457)75 mg secukinumab (AIN457)75 mg page 3 / 6
Inclusion Criteria plus placebo 150 mg subcutaneously once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 256. Total duration of therapy: 256 weeks from baseline Intervention Secukinumab 150 mg Secukinumab 150 mg plus placebo 75 mg once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 256 as subcutaneous injection. Total duration of therapy: 256 weeks from baseline Comparator Agent Placebo 75 mg and placebo 150 mg Age From Age To Gender Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 16 or week 24 as sc injection depend on patient responder or non responder status basesd on tender & swollen joint count. After that the Placebo arm patients will be shifted to active Secukinumab 75 mg or 150 mg arm. The same therapy will be continued from week 16 or week 24 till week 256. 1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed 2. Male or non-pregnant, non-lactating female subjects at least 18 years of age 3. Presence of RA classified by ACR 2010 revised criteria (see Appendix 2) for at least 3 months before screening At Baseline: Disease activity criteria defined by?6 tender joints out of 68 and? 6 swollen joints out of 66 WITH at least 1 of the following at screening: - Anti-CCP antibodies positive OR - Rheumatoid Factor positive AND WITH at least 1 of the following at screening: - hscrp? 10 mg/l OR - ESR?28 mm/1st hr 4. Subjects must have been taking at least one anti-tnf-? agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab given at an approved dose for at least 3 months before randomization and have experienced an page 4 / 6
Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Centralized Double Blind Double Dummy inadequate response to treatment or have been intolerant to at least one administration of an anti-tnf-? agent Exclusion Criteria 1. 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 2. RA subjects functional status class IV according to the ACR 1991 revised criteria (see Appendix 3) 3. Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) 4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor 5. Use of any investigational drug and/or devices within 4 weeks before randomization, or a period of 5 half-lives of the investigational drug, whichever is longer Primary Outcome Outcome Timepoints To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo in patients with active RA based on the proportion of patients achieving an ACR20 response. 52 weeks Secondary Outcome Outcome Timepoints 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) To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo in patients with active RA based on the proportion of subjects achieving an ACR50 response To demonstrate the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo with respect to the improvement (change) from baseline in HAQ-DI Total Sample Size=242 Sample Size from =20 27/02/2014 25/10/2012 Years=5 Months=0 Days=0 Other (Terminated) upto 52 weeks upto 52 weeks page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial Recruitment Status of Trial () Publication Details Brief Summary Other (Terminated) A phase 3 trial to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-tnf? agents. Planned no. of patients from : 25 FPFV achived on 27 Feb 2014 from page 6 / 6