PDF of Trial CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 21:08:26 GMT)
CTRI Number CTRI/2017/09/009748 [Registered on: 13/09/2017] - Trial Registered Prospectively Last Modified On 13/08/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohns Disease Scientific Title of Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy Study and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Secondary IDs if Any Secondary ID Identifier 2016-001367-36 EudraCT NCT02914561 ClinicalTrials.gov Details of Principal Details of Principal Investigator Investigator or overall Name Trial Coordinator (multi-center study) Designation Affiliation Address
Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Vaishali Karadkar Query) Designation Medical Monitor Affiliation Klinera Corporation India Address Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg,Ghatkopar West, Mumbai 400 086 Mumbai MAHARASHTRA 400086 India Phone 912225091470 Fax 912225091476 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Kalpesh Vispute Designation Clinical Project Manager Affiliation Klinera Corporation India Address Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg,Ghatkopar West, Mumbai 400 086 Mumbai MAHARASHTRA 400086 India
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Phone 912225091470 Fax 912225091476 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Gilead Sciences Inc, 333 Lakeside Drive Foster City, CA 94404, USA Primary Sponsor Primary Sponsor Details Name Gilead Sciences Inc Address 333 Lakeside Drive Foster City, CA 94404, USA Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor Klinera Corporation India Klinera Corporation India 401 Industrial Hill View Ghatkopar west, Mumbai-400086 Countries of List of Countries Recruitment Argentina Australia Austria Belgium Bulgaria Canada Croatia Czech Republic France Georgia Germany Greece Hong Kong Hungary Iceland India Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Norway Poland Portugal Republic of Korea Romania Russian Federation Serbia Singapore Slovakia South Africa
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Spain Sri Lanka Sweden Switzerland Taiwan Ukraine United Kingdom United States of America Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Vineet Ahuja All India Institute of Dept. of 91-1126588500 Medical Sciences Gastroenterology,Room No.3093, third [email protected] floor,New m Delhi-110029, India New Delhi DELHI Dr Shine Sadasivan Amrita Institute of Amrita Institiute of 91-9497556339 Medical Science and Medical Science and Research Center Research Center, [email protected] Amrita Lane, ta.edu Elamakkara P O Edappally, Kochi, Ernakulam, Kerala, India Ernakulam KERALA Dr Mahesh Kumar Apollo Gleneagles Institute of 91-3323205218 Goenka Hospitals Gastrosciences Day Care Building, 4th doctormaheshkumargo Floor, Apollo [email protected] Gleneagles Hospitals, 58 Canal Circular Road, Kolkata- 700054, West Bengal, India Kolkata WEST BENGAL Dr Ganesh Apollo Speciality Dept. of 91-4424334455 Subramanian Hospital Gastroenterology, No: 320, Padma complex, [email protected] Anna salai, om Chennai-600035, Tamil Nadu,India Chennai TAMIL NADU Dr Rupa Banerjee Asian Institute of Department of 91-23324255 Gastroenterology Gastroenterology, Asian Institute of Gastro dr_rupa_banerjee@hot enterology,6-3-661, mail.com Somajiguda, Hyderabad, Telangana 500082 Hyderabad ANDHRA PRADESH Dr Ravishankar Reddy Aware Global Hospital Aware Global Hospital, 91-3848407907 8-16-1, Inner Ring Rd, Laxmi Enclave, [email protected]
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Ramakrishnapuram, LB om Naga, Hyderabad, Telangana, India Hyderabad ANDHRA PRADESH Dr Kiran Kumar Jadhav B J Medical College & B.J. Medical College & 91-9823949126 Sassoon G Hospital Sassoon G. Hospital 91-20-26126868 ,Sassoon Road,Pune-4 [email protected] 11001,Maharashtra,Indi a Pune MAHARASHTRA Dr Samit Jain B.Y.L Nair CH Hospital Department of 91-2223021168 and T.N Medical Gastroenterology, New College OPD Building, 7th [email protected] Floor, Room no. 717, B.Y.L Nair CH Hospital and T.N Medical College, Dr. A. L. Nair Road, Mumbai-400008, Maharashtra, India. Mumbai MAHARASHTRA Dr Parshottam Koradia BAPS Pramukh Swami Adajan Char Rasta, 91-9825312027 Hospital Surat- 395009. Surat Purushottam_koradia@ GUJARAT yahoo.co.in Dr_Abhiram_Kognati Citizens Hospital 7th floor, Citizens 919849050950 Hospital, Near Aparna 914067191919 Sarovar, Nallagandla, kogantiabhiram@gmail. Serlingampally, com Hyderabad Hyderabad TELANGANA Dr Ajit Sood Dayanand Medical Dept. of 91-1614688800 College & Hospital Gastroenterology, Tagore Nagar, Civil [email protected] Lines, Ludhiana-141001, Punjab, India Ludhiana PUNJAB Dr Aejaz Habeeb Deccan College of Dept. of 91-4024340169 Medical Gastroenterology Sciences,Owaisi ,Kanchan bagh,Hydera aejazhabeeb@hotmail. Hospital& Reaserch bad-500058,Telangana, com Centre India Hyderabad ANDHRA PRADESH Dr Vinay Kumar Department of Post Department of Post 91-8008177113 Graduate Medicine, Graduate Medicine,GSVM dr.vinaysachan@gmail. Medical College,Kanpur com -208002,Uttar Pradesh,India Kanpur Nagar UTTAR PRADESH Dr Yogesh Batra Dr. B. L. Kapur Dr. B. L. Kapur 91-1130403040 Memorial Hospital Memorial Hospital,
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Pusa Road, New Delhi, [email protected] Delhi, India om New Delhi DELHI Dr S K Acharya Fortis Flt. Lt. Rajan Dept. of 91-1142776222 Dhall Hospital Gastroenterology, Sector B, Pocket 1, [email protected] Aruna Asaf Ali om Marg,Vasant Kunj, New Delhi, Delhi-110070, , India New Delhi DELHI Dr Mohinish Chhabra Fortis Hospital Fortis Hospital,Mohali,S 91-9814057593 ector-62,Phase-8,Mohal i-160062,Punjab,India chhabramohinish@gma Chandigarh il.com CHANDIGARH Dr Gourdas Choudhuri Fortis Memorial Fortis Memorial 91-01244962227 Research Institute Research Institute,Sector - 44, choudhuri.gour@gmail. Opposite HUDA City com Centre, Gurugram, Haryana 122002 Gurgaon HARYANA Dr Amarender S Puri G.B Pant Hospital Room No. 201, 91-23233001 Department of Gastroenterology, amarender.puri@gmail. Academic Block, G.B com Pant Hospital , New Delhi- 110002, Delhi, India. New Delhi DELHI Dr P Shravan Kumar Gandhi Hospital New Bhoiguda Road, 91-4027505566 5th Floor, Department of Gastroenterology,Se [email protected] cunderabad- 500003 om Telangana, India. Hyderabad ANDHRA PRADESH Dr Ravindra Gaadhe Gastroplus Digestive D-Block 3rd Floor, 91-9276558517 Disease Centre Pvt. Galaxy Bazar, Sunrise Ltd. Park Road, Vastrapur, gaadheravindra@yahoo Ahmedabad-380054, .co.in Gujarat India Ahmadabad GUJARAT Dr_Rami Reddy Gleneagles Global Gleneagles Global 919815192032 Hospitals Hospitals, 6-1-1070/1 to 914023244444 4, Lakdikapul, Opposite [email protected] Dwarka Hotel- 500004, Hyderabad, India Hyderabad TELANGANA Dr Adharsh C K Global Hospital Dept. of 919844136480 Gastroenterology, 67 918026255555 Uttarahall, Main Road, [email protected]
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Kengeri Bengaluru-560060, Karnataka, India Bangalore KARNATAKA Dr Nitin Pai Grant Medical Dept. of 91-2066455100 Foundation Ruby Hall Gastroenterology, 40 Clinic Sassoon Road ,Pune [email protected] ,Maharashtra-411001, India Pune MAHARASHTRA Dr BD Goswami Institute of digestive Institute of digestive 91-3612221962 and liver disease, and liver disease, Dispur Hospitals Pvt Ltd Dispur Hospitals Pvt [email protected] Ltd, Ganeshguri, om Guwahati: 781 006, Assam, India Kamrup ASSAM Dr Venkateswaran Institute of Medical Institute of Medical 91-7904285567 Arcot Rajeshwaran Gastroenterology, Gastroenterology, 91-44-25363970 RGGGH, Madras RGGGH, MMC, dr.venkateswaranar@g Medical College Chennai-600003, Tamil mail.com Nadu, India, Chennai TAMIL NADU Dr Gopal Krishna Dhali Institute of Post School of Digestive & 91-3322235181 Graduate Medical Liver Diseases, Institute Education and of Post Graduate [email protected] Research Medical Education and Research, Ronald Ross building, 4th floor, Room No- 17, 244 AJC bose road ,Kolkata- 700020, West Bengal, India Kolkata WEST BENGAL Dr Atul Shah Kaizen Hospital Institute of 91-7927914444 Gastroenterology and Research Centre, 132 [email protected] Feet Ring Road, Near m Helmet Circle, Ahmedabad – 380052, Gujarat, India Ahmadabad GUJARAT Dr Shiran Shetty Kasturba Medical Dept. of 918861920517 College Hospital Gastroenterology, Mani 91820-2922928 pal,Karnataka-576104, [email protected] India Udupi KARNATAKA Dr V Tantry Kasturba Medical Dept. of 91-8242445858 College Hospital Gastroenterology, Ambedkar Circle, [email protected] Mangalore-575001, Karnataka, India
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Udupi KARNATAKA Dr Ajay Kumar King George Medical King George Medical 91-9455519306 University University ,Department 91-522-2257539 of Surgical drajaymd12345@gmail. Gastroenterology,King com George Medical University,Shah Mina R oad,Lucknow-226003,U ttar Pradesh, India. Lucknow UTTAR PRADESH Dr Varadraj P Gokak KLES Dr. Prabhakar KLES Dr. Prabhakar 91-7353691777 Kore Hospital & M.R.C Kore Hospital & 91-831-2470732 M.R.C,NH Service [email protected] Road,Nehru Nagar,Belg aum-590010,Karnatak,I ndia Belgaum KARNATAKA Dr Abraham Koshy Lakeshore Hospital & Lakeshore Hospital & 91-4842772033 Research Centre Ltd Research Centre Ltd, NH Bypass, Nettoor, [email protected] Emakulam, Kochi 682040, Kerala, India Ernakulam KERALA Dr Meghraj Ingle Lokmanya Tilak Lokmanya Tilak 91-2224076381 Municipal General Municipal General Hospital Hospital Dr. Babasaheb [email protected] Ambedkar Road, Sion, Mumbai- 400022, Maharashtra, India Mumbai MAHARASHTRA Dr Dawney Zachariah Lourds Hospital Lourdes 91-8589951229 Hospital,Panchalam PO 91-484-2393720 ,Kochi,Ernakulum,Keral drdawneyzachariahlh@ a-682012,India gmail.com Ernakulam KERALA Dr Sathyaprakash B S M S Ramaiah Medical Department of 91-8023605190 College and Hospital Gastroenterology, M S Ramaiah Nagar, MSRIT [email protected] Post, Bangalore- m 560054, Karnataka,India Bangalore KARNATAKA Dr Vivek Bhatia Maharaja Agrasen West Punjabi Baug, 91-9811028897 Hospital, New Delhi, Delhi-110026 [email protected] New Delhi o.in DELHI Dr Saket Kumpawat Malpani Multispeciality Malpani Multispeciality 91-8890015234 Hospital Hospital,SP-6, Road Number 1,Sikar Road, drsaketagarwal1996@g Jaipur- 302013 , mail.com Rajasthan,India
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Jaipur RAJASTHAN Dr Kaushal Madan Max Smart Super Max Smart Super 91-9958787720 Speciality Hospital Speciality Hospital, Saket A unit of k_madan_2000@yahoo Gujarmal Modi Hospital .com & Research Centre for Medical Sciences, Mandir Marg, Press Enclave Road, Saket, New Delhi, Delhi 110017, India New Delhi DELHI Dr Shrikant Mukewar Midas Multispeciality Dept. of 91-7122442536 Hospital Pvt LTD Gastroenterology ,Fourth Floor, 7 - shrikant_mukewar@ya Central Bazar Road, hoo.com Ramdaspeth, Nagpur - 440 010, Maharashtra, India Nagpur MAHARASHTRA Dr Devendra Desai P D Hinduja National P D Hinduja National 91-9322596152 Hospital& Medical Hospital & Medical 91-2224440425 Research Center Research Centre, Veer dr_ddesai@hindujahos Savarkar Marg, Mahim, pital.com Mumbai - 400016, Maharashtra - India Mumbai (Suburban) MAHARASHTRA Dr Umesh Jalihal Prsitine Hospital & Pristine Hospital & 91-9845136766 Research Center Research Centre Pvt Ltd, 877, Dr M C Modi [email protected] Hospital Rd, K.N Extension, West of chord road, Stage 2, Nagapura, Bangaluru, Karnataka-560086 Bangalore KARNATAKA Dr Mathew Philip PVS Hospital Dept. of 91-4953011333 Gastroenterology, Banerji Rd, Kaloor, drmathewphilip@gmail. Ernakulam, Kerala- com 682017, India Ernakulam KERALA Dr Rahul Shah S. L Raheja Hospital Police Colony, Mahim 91-2267670136 400016 Mumbai (Suburban) [email protected] MAHARASHTRA m Mumbai MAHARASHTRA Dr SushilNarang SAL Hospital SAL Hospital,Opp. 91-7940054103 Doordarshan Tower Drive-in Road,Thaltej [email protected] ,Ahmedabad - 380 054 om ,Gujarat, India
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Ahmadabad GUJARAT Dr Hemant Gupta Samvedana Hospital Samvedana 91-5422276001 Hospital,Durgakund Rd, Opp. IP Vijaya Mall, [email protected] Bhelupur, Varanasi, m Uttar Pradesh 221005 Varanasi UTTAR PRADESH Dr Vinita Chodhari Sardar Patel Medical Department 91-9782300231 College & AG Hospital, Gastroenterology, PBM Hospital Bikaner -334 drchaudharyvinita@gm 003Rajasthan, India ail.com Bikaner RAJASTHAN Dr Aditya Kale Seth GS medical Dept. of 918962263999 College and KEM Gastroenterology, 912148-222148 Hospital Parel,Mumbai- 400012, [email protected] Maharashtra, India m Mumbai MAHARASHTRA Dr Chetan Mehta Shree Giriraj Dept. of 91-2812587087 Multispeciality Hospital Gastroenterology, Navjot Park Main Road, [email protected] 150 Ft Ring Road, Rajkot- 360002, Gujarat, India Rajkot GUJARAT Dr Sandeep Nijhaawan SMS Medical College Dept. of 91-1412560291 and Attached Hospital Gastroenterology,JLN Marg, Jaipur-302004, drnijhawansandeep@g Rajasthan, India. mail.com Jaipur RAJASTHAN Dr Mukesh Kalla SR Kalla Memorial Dept. of 91-7023006666 Gastro & General Gastroenterology Hospital ,78-79, Dhuleshwar [email protected] Garden, S P Marg, m Behind HSBC Bank, Sardar Patel Marg C-Scheme, Jaipur, Rajasthan 302001, India Jaipur RAJASTHAN Dr Shanthi Sri Ramchandra Dept. of 91-4445928506 Vijayaraghvan Medical Centre Gastroenterology ,No:1,Ramchandra Nag shanthi.vijayaraghavan ar,Porur,Chennai-6001 @gmail.com 16,Tamil Nadu, India Chennai TAMIL NADU Dr Pankaj Jain Sterling Hospital Sterling Hospital, 91-2652352900 Opposite INOX, near Natubhai Circle, Race [email protected] Course Circle(West), Vadodara- 390007, Gujarat
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Vadodara GUJARAT Dr Rohan Reddy Sunshine Hospitals Institute of 919849270700 Institute of Gastroenterology & 914044550000 Gastroenterology & Liver [email protected] Liver Disease Disease,Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana-500003,Indi a Hyderabad TELANGANA Dr Rajiv Mehta Surat Institute of Dept. of 91-2612800170 Digestive Sciences Gastroenterology, Second floor,Vijay [email protected] Nagar Gate No-3, Besides Nirman Bhavan, Opp Gandhi College, Majura Gate, Surat-395002, Gujarat , India Dohad GUJARAT Dr Amit Agrawal Suretech Hospital and Suretech Hospital and 91-7126636803 Research Centre Ltd Research Centre Ltd, 13-A Banerjee Marg, amitagrawal_80@rediff Dhantoli, Nagpur- mail.com 440012, Maharashtra, India Nagpur MAHARASHTRA Dr Prasad Bhate Universal Hospital Universal Hospital , 91-9511111222 Veer Santaji Ghorpade Rd, Lunanagar, [email protected] Rameshwar Chouk, om Kasba Peth, Pune, Maharashtra 411011 Pune MAHARASHTRA Dr V G Mohan Prasad VGM Hospital -Institute VGM Hospital -Institute 91-422572207 of Gastroenterology of Gastroenterology, No. 2100, Trichy Road, [email protected] Rajalakshmi Mills Stop, m Coimbatore-641005, Tamil Nadu, India. Coimbatore TAMIL NADU Dr Pravesh Kumar Jain Victoria Hospital Victoria Hospital, Near 91-08026701150 City Market,Fort Road, Bangalore,Karnataka-5 drjainpravesh1@gmail. 60002,India com Bangalore KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Surat Institute of Approved 07/06/2017 No Digestive Sciences
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Ethics Committee, Dr. Rajiv Mehta Institutional Ethics Approved 19/07/2017 No Committee,Midas Multispeciality Hospital Pvt LTD, Dr. Shrikant Mukewar The Ethics Committee, Approved 28/06/2018 No SMS Medical College and Attached Hospital, Dr. Sandeep Nijhawan Ethics Committee, PVS Approved 23/10/2017 No Memorial Hospital Pvt Ltd, Dr. Mathew Philip Institutional Ethics Approved 24/10/2017 No Committee, All India Institute of Medical Sciences (AIIMS), Dr. Vineet Ahuja Drug Trial Ethics Approved 21/11/2017 No Committee,Dayanand Medical College & Hospital, Dr. Ajit Sood IPGME&R Research Approved 25/08/2017 No Oversight Committee, Dr. G. K. Dhali Institutional Ethics Approved 08/08/2017 No Committee, Gandhi Medical College, Dr. P. Shravan Kumar Institutional Ethics Approved 05/02/2020 No Committee,Sunshine Hospitals, Dr. Ravi Shankar Ethics Committee for Approved 15/09/2017 No Research , Fortis Flt. Lt. Rajan Dhall Hospital, Dr. S. K. Acharya Shree Giriraj Hospital Approved 19/06/2017 No Research Ethics Committee, Dr. Chetan Mehta Manipal University Approved 12/08/2017 No Ethics Committee, Dr. V Tantry Institutional Ethics Approved 01/01/2020 No Committee – BGS Global Hospital, Dr. Adarsh.C.K_ Kaizen Ethics Approved 19/06/2017 No Committee, Dr. Atul Shah SR Kalla Memorial Approved 14/06/2017 No Ethical Committee for Human Research, Dr. Mukesh Kalla Institutional Ethics Approved 12/08/2017 No
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Committee, Dr. Aejaz Habeeb Institutional Ethics Submittted/Under No Date Specified No Committee, Dr. Shanthi Review Vijayaraghvan Institutional Ethics Approved 28/07/2017 No Committee – Clinical Studies, Dr. Ganesh Subramanian Institutional Ethics Approved 27/06/2017 No Committee Poona Medical Research Foundation, Dr. Nitin Pai Ethics Committee, M S Approved 29/06/2017 No Ramaiah Medical College and Hospitals, Sathyaprakash B. S. Manipal University Approved 07/03/2020 No Ethics Committee, Dr. Shiren Shetty Institutional Review Approved 25/10/2018 No Board,S L Raheja Hospital, Dr. Rahul Shah Institutional Ethics Approved 27/01/2021 No Committee, Dr_Aditya_Kale Institutional Ethics Approved 26/02/2018 No Committee-Human Research, Dr. Meghraj Ingle Institutional Ethics Approved 04/05/2018 No Committee, Fortis Memorial Research Institute, Dr Gourdas Choudhuri Samvedna Hospital Approved 13/11/2017 No Ethics Committee, Dr. Hemant Gupta Midas multispecialty Approved 09/04/2018 No hospital institutional ethics committee, Dr Amit Agrawal Institutional Ethics Approved 18/11/2017 No Committee , Dr Prasad Bhate Dr. B.L.Kapur Memorial Approved 11/01/2018 No Hospital Ethics Committee, Dr Yogesh Batra Institutional Ethics Approved 20/01/2018 No Committee, Apollo Gleneagles Hospitals, Dr Mahesh Kumar Goenka Institutional ethics Submittted/Under No Date Specified No
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Committee, Topiwala Review National Medical College and BYL Nair Charitable Hospital, Dr Samit Jain Institutional Ethics Approved 13/11/2017 No Committee, Sterling Hospital, Dr Pankaj Jain Institutional Ethics Approved 02/12/2017 No Committee- VGM Hospital, Dr VG Mohan Prasad Institutional Ethics Submittted/Under No Date Specified No Committee,Maulana Review Azad Medical College, Dr Amarender S Puri Ethics Committee, Approved 21/01/2019 No Dispur Hospitals Pvt. Ltd, Dr B.D Goswami Institutional Ethics Approved 13/02/2018 No Committee, Malpani Multispeciality Hospital, Dr Saket Kumpawat Institutional Ethics Approved 27/02/2018 No Committee, S. A. L. Hospital and Medical Institute, Dr Sushil Narang Ethics Committee, Approved 15/09/2018 No Bangalore Medical College and Research Institute, Dr Pravesh Kumar Jain Lakeshore Ethics Approved 22/03/2018 No Committee, Dr Abraham Koshy Institutional Ethics Approved 25/03/2021 No Committee , Global Hospitals, Dr.Rami Reddy Institutional Ethics Approved 06/04/2018 No Committee , Global Hospitals, Dr Ravishankar Reddy Institutional Ethics Approved 20/04/2018 No Committee, Max Smart Super Speciality Hospital, Dr. Kaushal Madan Institutional Ethics Approved 24/09/2018 No Committee, Amrita Institute of Medical Sciences and Research Center, Dr. Shine Sadashivan Institutional Ethics Approved 05/07/2018 No Committee, Lourdes Hospital, Dr. Dawney
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Zachariah Institutional Ethics Submittted/Under No Date Specified No Committee, Madras Review Medical College, Dr. Venkateswaran Institutional Ethics Approved 06/10/2018 No Committee, B J Medical College, Sassoon Hospital,Dr. Kiran Kumar Jadhav Institutional Ethics Approved 10/08/2018 No Committee, King George Medical University, Dr. Ajay Kumar Institutional Ethics Approved 10/09/2018 No Committee, KLES Dr. Prabhakar Kore, Dr. Varadraj Gokak Institutional Ethics Approved 17/12/2018 No Committee, P D Hinduja National Hospital & Medical Research Center, Dr Devendra Desai Institutional Ethics Submittted/Under No Date Specified No Committee, Pristine Review Hospital & Research Center, Dr. Umesh Jalihal Institutional Ethics Approved 22/06/2021 No Committee, Citizen Hospital, Dr.Abhiram Koganti Institutional Ethics Approved 05/10/2018 No Committee, GSVM Medical College, Kanpur, Dr. Vinay Kumar Institutional Ethics Submittted/Under No Date Specified No Committee, Fortis Review Hospital, Mohali, Dr. Mohinish Chhabra Institutional Ethics Approved 12/12/2019 No Committee, Asian Institute of Gastroenterology, Dr. Rupa Banerjee Gastroplus Ethics Approved 16/11/2019 No Committee, Dr. Ravindra Gaadhe Institutional Ethics Approved 30/10/2019 No Committee, Maharaja Agrasen Hospital, Dr. Vivek Bhatia ETHICS COMMITTEE, Submittted/Under No Date Specified No S.P.MEDICAL Review COLLEGE, Dr Vinita
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Chodhari BAPS Pramukh Swami Submittted/Under No Date Specified No Hospital Institutional Review Ethics Committee, Dr Parshottam Koradia Regulatory Clearance Status Date Status from DCGI Approved/Obtained 19/07/2017 Health Condition / Health Type Condition Problems Studied Patients Moderately to Severely Active Crohn’s Disease Intervention / Type Name Details Comparator Agent Intervention Induction Study Experimental Drug filgotinib Tablet filgotinib dose A filgotinib dose administered orally once daily, A and placebo to match Other Names GS-6034 filgotinib dose B for 10 weeks GLPG0634, Drug placebo to match filgotinib, Tablet(s) administered orally once daily Intervention Induction Study Experimental Drug: filgotinib tablet filgotinib dose B filgotinib dose administered orally once daily, B and placebo to match Other Names: GS-6034 filgotinib dose A for 10 weeks GLPG0634, Drug: placebo to match filgotinib tablet administered orally once daily Intervention Experimental: Maintenance Drug: filgotinib tablet Study, Participants who meet administered orally once daily, response or remission criteria at Other Names GS-6034 Week 10 will continue into the GLPG0634, Drug: placebo to maintenance Study and receive match filgotinib tablet filgotinib and/or placebo for 48 administered orally once daily weeks Comparator Agent Induction Study Placebo, Drug: placebo to match filgotinib placebo to match filgotinib dose tablet(s) administered orally A and placebo to match once daily filgotinib dose B for 10 weeks Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details • Males or non-pregnant, non-lactating females, ages 18 to 75 years,
inclusive based on the date of the screening visit
• Documented diagnosis of CD with a minimum disease duration of 3
months with involvement of the ileum and/or colon at a minimum, as
determined by histopathology and endoscopic assessment
• Moderately to severely active CD
• Previously demonstrated an inadequate clinical response, loss of response
to, or intolerance to at least 1 of the following agents: corticosteroids,
immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or
vedolizumab Exclusion Criteria Exclusion Criteria Details • Current complications of CD such as symptomatic strictures, severe rectal/ anal stenosis, short bowel syndrome, etc. • Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon • Active tuberculosis (TB) or history of latent TB that has not been treated
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• Use of any prohibited concomitant medications as described in the study protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. Method of Generating Computer generated randomization Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints 1. Induction Study: Proportion of Participants Week 10 Achieving Clinical Remission by Patient Week 58 Reported Outcomes (PRO2) at Week 10 [Time Frame: Week 10] 2. Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10 [Time Frame: Week 10] 3. Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [Time Frame: Week 58] 4. Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [Time Frame: Week 58] Secondary Outcome Outcome Timepoints Induction Study: Proportion of Participants Week 10 Achieving Clinical Remission by Crohns Disease Activity Index (CDAI) at Week 10 Induction Study: Proportion of Participants Week 10 Achieving Both Clinical Remission by PRO2 and endoscopic response at Week 10 (Composite Endpoint) Induction Study: Pharmacokinetic Week 4 postdose and Week 10 predose Concentrations of Filgotinib and its Metabolite GS-829845 Maintenance Study: Proportion of Participants Week 58 Achieving Clinical Remission by CDAI at Week 58 Maintenance Study: Proportion of Participants Week 10 & Week 58 Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58 Maintenance Study: Proportion of Participants Week 58 Achieving Both Clinical Remission by PRO2 and Endoscopic Response at Week 58 (Composite Endpoint) Maintenance Study: Proportion of Participants Week 58 Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 Maintenance Study: Pharmacokinetic Plasma Week 26 (predose or postdose) and Week 58 Concentrations of Filgotinib and its Metabolite predose GS-829845 Target Sample Size Total Sample Size=1320
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Sample Size from India=200 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 3 Date of First 06/10/2017 Enrollment (India) Date of First 31/10/2016 Enrollment (Global) Estimated Duration of Years=5 Trial Months=0 Days=0 Recruitment Status of Open to Recruitment Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details None yet Brief Summary The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohns disease in participants who are biologic naive and biologic experienced
Participants who complete the study or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long term extension study GS US 419 3896
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