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CTRI Number  CTRI/2017/08/009477 [Registered on: 23/08/2017] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Other 
Public Title of Study
Modification(s)  		 Filgotinib in Long-Term Extension Study of Adults With Crohns Disease 
Scientific Title of Study
Modification(s)  		 A Long-Term Extension Study to Evaluate the Safety of filgotinib in Subjects with Crohn’s Disease 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2016-002763-34  EudraCT 
NCT02914600  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sherin Eddin 
Designation  Medical Monitor 
Affiliation  Klinera Corporation India 
Address  Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg,Ghatkopar West, Mumbai 400 086
Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg,Ghatkopar West, Mumbai 400 086
Mumbai
MAHARASHTRA
400086
India 
Phone  912249781252   
Fax  912225004588  
Email  sherin.eddin@klinera.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Pritesh Tailor 
Designation  Sr Clinical Project Manager 
Affiliation  Klinera Corporation India 
Address  Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg, Ghatkopar West, Mumbai 400 086
Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg, Ghatkopar West, Mumbai 400 086
Mumbai
MAHARASHTRA
400086
India 
Phone  912249781252   
Fax  912225004588  
Email  ptailor@klinera.com  
 
Source of Monetary or Material Support  
Gilead Sciences Inc 333 Lakeside Drive Foster City, CA 94404, USA 
 
Primary Sponsor  
Name  Gilead Sciences Inc 
Address  333 Lakeside Drive Foster City, CA 94404, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Klinera Corporation India  401 Industrial Hill View Ghatkopar west, Mumbai-400086 
 
Countries of Recruitment
Modification(s)  		   Australia
Austria
Bulgaria
Canada
France
Germany
Greece
Hong Kong
Japan
Mexico
New Zealand
Poland
Portugal
South Africa
Spain
Sweden
Switzerland
Taiwan
Ukraine
United Kingdom
United States of America
Belgium
Croatia
Czech Republic
Hungary
Iceland
Ireland
Israel
Italy
Republic of Korea
Romania
Russian Federation
Slovakia
Argentina
Georgia
India
Malaysia
Netherlands
Norway
Serbia
Singapore
Sri Lanka  
Sites of Study
Modification(s)  
No of Sites = 47  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aejaz Habeeb  Deccan College of Medical Sciences Owaisi Hospital& Reaserch Centre  Dept. of Gastroenterology ,Kanchan bagh,Hyderabad-500058,Telangana,India
Hyderabad
ANDHRA PRADESH 		 91-4024340169

aejazhabeeb@hotmail.com 
Dr Ravindra B S  Global Hospital  Dept. of Gastroenterology, 67 Uttarahall, Main Road, Kengeri Bengaluru-560060, Karnataka, India
Bangalore
KARNATAKA 		 91-8030444444

drravindrabs@gmail.com 
Dr Vineet Ahuja  All India Institute of Medical Sciences  Dept. of Gastroenterology,Room No.3093, third floor,New Delhi-110029, India
New Delhi
DELHI 		 91-1126588500

vins_ahuja@hotmail.com 
Dr Shine Sadasivan  Amrita Institute of Medical Science and Research Center  Amrita Institiute of Medical Science and Research Center, Amrita Lane, Elamakkara P O Edappally, Kochi, Ernakulam, Kerala, India
Ernakulam
KERALA 		 91-9497556339
91-48-4280120
shines1560@aims.amrita.edu 
Dr Mahesh Kumar Goenka  Apollo Gleneagles Hospitals  Institute of Gastrosciences Day Care Building, 4th Floor, ApolloGleneagles Hospitals, 58 Canal Circular Road, Kolkata- 700054, West Bengal, India
Kolkata
WEST BENGAL 		 91-3323205218

doctormaheshkumargoenka@gmail.com 
Dr Ganesh Subramanian  Apollo Speciality Hospital  Dept. of Gastroenterology, No: 320, Padma complex, Anna salai, Chennai-600035, TamilNadu,India
Chennai
TAMIL NADU 		 91-4424334455

gastroganesh@gmail.com 
Dr Ravishankar Reddy  Aware Global Hospital   Aware Global Hospital, 8-16-1, Inner Ring Rd, Laxmi Enclave, Ramakrishnapuram, LB Naga, Hyderabad, Telangana, India
Hyderabad
ANDHRA PRADESH 		 91-3848407907

drnravisankar@yahoo.com 
Dr Kiran Kumar Jadhav  B J Medical College & Sassoon G Hospital  B.J. Medical College & Sassoon G. Hospital ,Sassoon Road,Pune-411001,Maharashtra,India
Pune
MAHARASHTRA 		 91-9823949126
91-20-26126868
drkpjadhav@gmail.com 
Dr Abhiram Kognati  Citizens Hospital  Citizens Hospital, 7th Floor, Near Aparna Sarovar, Nallagandla, Serlingampally, Hyderabad
Hyderabad
TELANGANA 		 919849050950
914067191919
kogantiabhiram@gmail.com 
Dr Ajit Sood  Dayanand Medical College & Hospital  Dept. of Gastroenterology, Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab, India
Ludhiana
PUNJAB 		 91-1614688800

ajitsood10@gmail.com 
Dr Yogesh Batra  Dr. B. L. Kapur Memorial Hospital  Dr. B. L. Kapur Memorial Hospital, Pusa Road, New Delhi
New Delhi
DELHI 		 91-1130403040

dryogeshbatra@gmail.com 
Dr Subrat Kumar Acharya  Fortis Flt. Lt. Rajan Dhall Hospital  Dept. of Gastroenterology, Sector B, Pocket 1, Aruna Asaf Ali Marg,Vasant Kunj, New Delhi, Delhi-110070, , India
New Delhi
DELHI 		 91-1142776222

subratacharya@gmail.com 
Dr Gourdas Choudhuri  Fortis Memorial Research Institute  Fortis Memorial Research Institute,Sector - 44, Opposite HUDA City Centre, Gurugram, Haryana 122002
Gurgaon
HARYANA 		 91-01244962227

choudhuri.gour@gmail.com 
Dr P Shravan Kumar  Gandhi Hospital  New Bhoiguda Road, 5th Floor, Department of Gastroenterology,Secunderabad- 500003 Telangana, India.
Hyderabad
ANDHRA PRADESH 		 91-4027505566

shravangastro@gmail.com 
Dr Rami Reddy   Gleneagles Global Hospitals   Gleneagles Global Hospitals, 6-1-1070/1 to 4, Lakdikapul, Opposite Dwarka Hotel- 500004, Hyderabad, India
Hyderabad
TELANGANA 		 919815192032
914023244444
yrrpgi@gmail.com 
Dr Nitin Pai  Grant Medical Foundation Ruby Hall Clinic  Dept. of Gastroenterology,40 Sassoon Road,Pune,Maharashtra-41 1001, India
Pune
MAHARASHTRA 		 91-2066455100

drnitinpai@gmail.com 
Dr Vinay Kumar  GSVM Medical College  Department of Post Graduate Medicine,GSVM Medical College,Kanpur-208002,Uttar Pradesh,India
Kanpur Nagar
UTTAR PRADESH 		 91-8008177113

dr.vinaysachan@gmail.com 
Dr BD Goswami  Institute of digestive and liver disease, Dispur Hospitals Pvt Ltd  Institute of digestive and liver disease, Dispur Hospitals Pvt Ltd, Ganeshguri, Guwahati: 781 006, Assam, India
Kamrup
ASSAM 		 91-3612221962

bhabadev@rediffmail.com 
Dr Venkateswaran Arcot Rajeshwaran  Institute of Medical Gastroenterology, RGGGH, Madras Medical College  Institute of Medical Gastroenterology, RGGGH, MMC, Chennai-600003, Tamil Nadu, India,
Chennai
TAMIL NADU 		 91-7904285567
91-44-25363970
dr.venkateswaranar@gmail.com 
Dr Atul Shah  Kaizen Hospital  Institute of Gastroenterology and Research Centre, 132 Feet Ring Road, Near Helmet Circle,Ahmedabad – 380052,Gujarat, India
Ahmadabad
GUJARAT 		 91-7927914444

dratul_aash@yahoo.com 
Dr Shiran Shetty   Kasturba Medical College Hospital  Dept. of Gastroenterology, Manipal,Karnataka-576104, India
Udupi
KARNATAKA 		 91-8861920517
91-820-2922928
drshiran@gmail.com 
Dr Vishwanath Tantry  Kasturba Medical College Hospital  Dept. of Gastroenterology, Ambedkar Circle, Mangalore-575001, Karnataka, India
Udupi
KARNATAKA 		 91-8242445858

tantrybv@gmail.com 
Dr Ajay Kumar  King George Medical University  King George Medical University ,Department of Surgical Gastroenterology,King George Medical University,Shah Mina Road,Lucknow-226003,Uttar Pradesh, India.
Lucknow
UTTAR PRADESH 		 91-9455519306
91-522-2257539
drajaymd12345@gmail.com 
Dr Varadraj P Gokak  KLES Dr. Prabhakar Kore Hospital & M.R.C  KLES Dr. Prabhakar Kore Hospital & M.R.C,NH Service Road,Nehru Nagar,Belgaum-590010,Karnatak,India
Belgaum
KARNATAKA 		 91-7353691777
91-831-2470732
vpgokak@gmail.com 
Dr Abraham Koshy  Lakeshore Hospital & Research Centre Ltd  Lakeshore Hospital & Research Centre Ltd, NH Bypass, Nettoor, Emakulam, Kochi 682040, Kerala, India
Ernakulam
KERALA 		 91-4842772033

koshyabe@yahoo.com 
Dr Meghraj Ingle  Lokmanya Tilak Municipal General Hospital  Lokmanya Tilak Municipal General Hospital Dr. Babasaheb Ambedkar Road, Sion, Mumbai- 400022, Maharashtra, India
Mumbai
MAHARASHTRA 		 91-2224076381

drmeghraj@gmail.com 
Dr Dawney Zachariah  Lourds Hospital  Lourdes Hospital,Pachalam PO, Ernakulam, Kochi, Kerala 682012
Ernakulam
KERALA 		 91-8589951229

drdawneyzachariahlh@gmail.com 
Dr Sathyaprakash B S  M S Ramaiah Medical College and Hospital,Department of Gastroenterology  Dept. of Gastroenterology,M S Ramaiah Nagar, MSRIT Post, Bangalore 560054,Karnataka,India
Bangalore
KARNATAKA 		 91-8023605190

satyaprakash@gmail.com 
Dr Kaushal Madan  Max Smart Super Speciality Hospital  Max Smart Super Speciality Hospital, Saket A unit of Gujarmal Modi Hospital & Research Centre for Medical Sciences, Mandir Marg, Press Enclave Road, Saket, New Delhi, Delhi 110017, India
New Delhi
DELHI 		 91-9958787720
91-11-26510050
k_madan_2000@yahoo.com 
Dr Shrikant Mukewar  Midas Multispeciality Hospital Pvt Ltd  Dept. of Gastroenterology ,Fourth Floor,7-Central Bazar Road, Ramdaspeth, Nagpur - 440 010, Maharashtra, India
Nagpur
MAHARASHTRA 		 91-7122434242

shrikant_mukewar@yahoo.com 
Dr Devendra Desai  P D Hinduja National Hospital& Medical Research Center  P D Hinduja National Hospital & Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai - 400016, Maharashtra - India
Mumbai (Suburban)
MAHARASHTRA 		 91-9322596152
91-2224440425
dr_ddesai@hindujahospital.com 
Dr Mathew Philip  PVS Hospital  Dept. of Gastroenterology, Banerji Rd, Kaloor, Ernakulam, Kerala- 682017, India
Ernakulam
KERALA 		 91-495-3011333

drmathewphilip@gmail.com 
Dr Rahul Shah  S. L Raheja Hospital  Police Colony, Mahim 400016
Mumbai (Suburban)
MAHARASHTRA 		 912266529999

rahulshah@hotmail.com 
Dr Sushil Narang   SAL Hospital   SAL Hospital,Opp. Doordarshan Tower Drive-in Road,Thaltej ,Ahmedabad - 380 054 ,Gujarat, India
Ahmadabad
GUJARAT 		 91-7940054103

drsonunarang@gmail.com 
Dr Hemant Gupta  Samvedana Hospital  Samvedana Hospital,Durgakund Rd, Opp. IP Vijaya Mall, Bhelupur, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 		 91-5422276001

hemantg26@yahoo.com 
Dr Gopal Krishna Dhali  School of Digestive & Liver Diseases, Institute of Post Graduate Medical Education and Research  Ronald Ross building, 4th floor, Room No- 17, 244 AJC bose road ,Kolkata- 700020, West Bengal, India
Kolkata
WEST BENGAL 		 91-3322235181

gkdhali@yahoo.co.in 
Dr Aditya Kale  Seth GS medical College and KEM Hospital  Dept. of Gastroenterology, Parel,Mumbai- 400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 918962263999
912148-222148
adityapkale@yahoo.com 
Dr Chetan Mehta  Shri Griraj Multispeciality Hospital  Dept. of Gastroenterology, Navjot Park Main Road, 150 Ft Ring Road, Rajkot- 360002, Gujarat, India
Rajkot
GUJARAT 		 91-2812587087

mehtacn@hotmail.com 
Dr Sandeep Nijhaawan  SMS Hospital  Dept. of Gastroenterology,JLN Marg, Jaipur-302004, Rajasthan, India.
Jaipur
RAJASTHAN 		 91-141-2560291

drnijhawansandeep@gmail.com 
Dr Mukesh Kalla  SR Kalla Memorial Gastro & General Hospital  Dept. of Gastroenterology, 78-79, Dhuleshwar Garden, S P Marg, Behind HSBC Bank, Sardar Patel Marg C-Scheme, Jaipur, Rajasthan 302001, India
Jaipur
RAJASTHAN 		 91-7023006666

drmkalla@rediffmail.com 
Dr Pankaj Jain  Sterling Hospital  Sterling Hospital, Opposite INOX, near Natubhai Circle, Race Course Circle(West), Vadodara- 390007, Gujarat
Vadodara
GUJARAT 		 91-2652352900

jain_pass@yahoo.com 
Dr Rohan Reddy   Sunshine Hospital  Dept. of Gastroenterology, Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana-500003, , India
Hyderabad
TELANGANA 		 919849270700
914044550000
rohan219@gmail.com 
Dr Rajiv Mehta  Surat Institute of Digestive Sciences  Dept. of Gastroenterology,Second Floor, Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opp Gandhi College, Majura Gate, Surat-395002, Gujarat , India
Dohad
GUJARAT 		 91-2612800000

rmgastro@yahoo.com 
Dr Amit Agrawal  Suretech Hospital and Research Centre Ltd  Suretech Hospital and Research Centre Ltd, 13-A Banerjee Marg, Dhantoli, Nagpur- 440012, Maharashtra, India
Nagpur
MAHARASHTRA 		 91-7126636803

amitagrawal_80@rediffmail.com 
Dr Prasad Bhate  Universal Hospital   Universal Hospital , Veer Santaji Ghorpade Rd, Lunanagar, Rameshwar Chouk, Kasba Peth, Pune, Maharashtra 411011
Pune
MAHARASHTRA 		 91-9511111222

drprasadbhate@gmail.com 
Dr V G Mohan Prasad  VGM Hospital -Institute of Gastroenterology  VGM Hospital -Institute of Gastroenterology, No. 2100, Trichy Road, Rajalakshmi Mills Stop, Coimbatore-641005, Tamil Nadu, India.
Coimbatore
TAMIL NADU 		 91-422572207

drvgmprasad@gmail.com 
Dr Parvesh Kumar Jain  Victoria Hospital  Victoria Hospital, Near City Market,Fort Road,Bangalore,Karnataka-560002,India
Bangalore
KARNATAKA 		 91-08026701150

drjainpravesh1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 52  
Name of Committee  Approval Status 
Institutional Ethics Committee – BGS Global Hospital,BGS Global Hospitals, Dr. Ravindra B.S.  Approved 
BAPS Pramukh Swami Hospital Institutional Ethics Committee, Dr Parshottam Koradia  Submittted/Under Review 
Dr. B.L.Kapur Memorial Hospital Ethics Committee, Dr Yogesh Batra  Approved 
Drug Trial Ethics Committee,Dayanand Medical College & Hospital, Dr. Ajit Sood  Approved 
Ethics Committee for Research , Fortis Flt. Lt. Rajan Dhall Hospital, Dr. Subrat Kumar Acharya  Approved 
Ethics Committee, M S Ramaiah Medical College and Hospitals,Dr.Sathyaprakash B.S  Approved 
Ethics Committee, Bangalore Medical College and Research Institute, Dr Parvesh Kumar Jain   Approved 
Ethics Committee, Dispur Hospitals Pvt. Ltd, Dr B.D Goswami  Approved 
Ethics Committee, PVS Memorial Hospital Pvt Ltd, Dr. Mathew Philip  Approved 
ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, Dr Vinita Chodhari  Submittted/Under Review 
Ethics Committee,S. L Raheja Hopspital,Dr.Rahul Shah  Submittted/Under Review 
Gastroplus Ethics Committee, Gastroplus Digestive Disease Centre Pvt. Ltd. Dr. Ravindra Gaadhe  Submittted/Under Review 
Institutional Ethics Committee , Dr Prasad Bhate  Approved 
Institutional Ethics Committee , Global Hospitals, Dr Ravishankar Reddy  Approved 
Institutional Ethics Committee , Global Hospitals, Dr. Rami Reddy  Approved 
Institutional Ethics Committee – Clinical Studies, Apollo Hospitals, Apollo Hospitals Enterprise Limited,Dr.Ganesh Subramanian  Approved 
Institutional Ethics Committee Poona Medical Research Foundation,Dr.Nitin Pai  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), Dr. Vineet Ahuja  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Center, Dr. Shine Sadashivan  Approved 
Institutional Ethics Committee, Apollo Gleneagles Hospitals, Dr Mahesh Kumar Goenka  Approved 
Institutional Ethics Committee, Asian Institute of Gastroenterology, Dr. Rupa Banerjee  Approved 
Institutional Ethics Committee, B J Medical College & Sassoon G Hospital, Dr. Kiran Kumar Jadhav  Approved 
Institutional Ethics Committee, Citizens Hospital, Dr. Abhiram Kognati  Approved 
Institutional Ethics Committee, Deccan College of Medical Science, Owaisi Hospital & Research Centre, Dr. Aejaz Habeeb  Approved 
Institutional Ethics Committee, Fortis Memorial Research Institute, Dr Gourdas Choudhuri  Approved 
Institutional Ethics Committee, Gandhi Medical College, Dr. P. Shravan Kumar  Approved 
Institutional Ethics Committee, GSVM Medical College, Kanpur, Dr. Vinay Kumar  Approved 
Institutional Ethics Committee, King George Medical University, Dr. Ajay Kumar  Approved 
Institutional Ethics Committee, KLES Dr. Prabhakar Kore, Dr. Varadraj Gokak  Approved 
Institutional Ethics Committee, Lourdes Hospital, Dr. Dawney Zachariah  Approved 
Institutional Ethics Committee, Max Smart Super Speciality Hospital, Dr. Kaushal Madan  Approved 
Institutional Ethics Committee, P D Hinduja NAtional Hospital & Medical Research Center, Dr Devendra Desai  Approved 
Institutional Ethics Committee, RGGGH, MMC, Dr. Venkateswaran Arcot Rajeshwaran  Submittted/Under Review 
Institutional Ethics Committee, S. A. L. Hospital and Medical Institute, Dr Sushil Narang  Approved 
Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Dr. Aditya Kale  Approved 
Institutional Ethics Committee, Sterling Hospital, Dr Pankaj Jain   Approved 
Institutional Ethics Committee,Midas Multispeciality Hospital Pvt LTD, Dr. Shrikant Mukewar  Approved 
Institutional Ethics Committee,Sunshine Hospitals, Dr.Rohan_Reddy  Approved 
Institutional Ethics Committee- VGM Hospital, Dr VG Mohan Prasad   Approved 
Institutional Ethics Committee-Human Research, Dr. Meghraj Ingle  Approved 
IPGME&R Research Oversight Committee, Dr. Gopal Krishna Dhali  Approved 
Kaizen Ethics Committee, Kaizen Hospital, Institute of Gastroenterology and Research Centre, Dr.Atul Shah  Approved 
Lakeshore Ethics Committee, Dr Abraham Koshy  Approved 
Maharaja Agrasen Hospital Institutional Ethics Committee, Dr. Vivek Bhatia  Submittted/Under Review 
Manipal University Ethics Committee, Dr. B.Vishwanath Tantry  Approved 
Manipal University Ethics Committee, Dr. Shiren Shetty  Approved 
Midas multispecialty hospital institutional ethics committee, Dr Amit Agrawal   Approved 
Samvedna Hospital Ethics Committee, Dr. Hemant Gupta  Approved 
Shree Giriraj Hospital Research Ethics Committee, Dr. Chetan Mehta  Approved 
SR Kalla Memorial Ethical Committee for Human Research, S.R.Kalla Memorial Gastro & General Hospital,Dr.Mukesh Kalla  Approved 
Surat Institute of Digestive Sciences Ethics Committee, Dr. Rajiv Mehta  Approved 
The Ethics Committee,SMS Medical College and Attached Hospital, Dr. Sandeep Nijhawan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Crohn’s Disease,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Experimental: filgotinib dose A (blinded dosing), filgotinib dose A and placebo to match filgotinib dose B for up to 144 weeks  Drug: filgotinib, Tablet administered orally once daily, Other Names: • GS-6034 • GLPG0634, Drug: placebo, Tablets administered orally once daily 
Intervention  Experimental: filgotinib dose A (open-label) filgotinib dose A for up to 144 weeks  Drug: filgotinib, Tablets administered orally once daily Other Names: • GS-6034 • GLPG0634 
Intervention  Experimental: filgotinib dose B (blinded dosing) filgotinib dose B and placebo to match filgotinib dose A for up to 144 weeks  Drug: filgotinib, Tablets administered orally once daily, Other Names: •GS-6034 •GLPG0634, Drug: placebo, Tablets administered orally once daily 
Intervention  Experimental: filgotinib dose B (open-label) filgotinib dose B for up to 144 weeks  Drug: filgotinib, Tablets administered orally once daily, Other Names: • GS-6034 • GLPG0634 
Comparator Agent  Placebo Comparator: placebo (blinded dosing), Placebo for up to 144 weeks  Drug: placebo, Tablets administered orally once daily 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  • Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
• Must have met all eligibility criteria from a Gilead-sponsored CD parent protocol
• Females of childbearing potential must have a negative pregnancy test at Day 1
• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method of contraception as described in the study protocol, for the duration described
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
• Must have completed all required procedures or met protocol specified
efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib
treatment study for CD 
 
ExclusionCriteria 
Details  • Known hypersensitivity to the study drug
• Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol
• Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the study protocol
• Use of prohibited medications as outlined in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and
Abnormal Clinical Laboratory Tests 		 Up to 432 weeks  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Change from Baseline in PRO2 Scores
PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency. 		 Baseline and up to 432 weeks 
Change from Baseline in Crohns Disease Activity Index (CDAI) Scores  Baseline and up to 432 weeks 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "1188"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 10/12/2017 
Date of Study Completion (India) 01/08/2023 
Date of First Enrollment (Global)  17/03/2017 
Date of Study Completion (Global) 01/08/2023 
Estimated Duration of Trial
Modification(s)  		 Years="12"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication details as of now 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
The primary objective of this study is to observe the long term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead sponsored filgotinib treatment study in Crohns disease
 
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