KlinEra Global Services
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai 400086, India
KlinEra Global Services
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai 400086, India Mumbai MAHARASHTRA 400086 India
Phone
912249781252
Fax
912225091476
Email
ptailor@klinera.com
Source of Monetary or Material Support
Gilead Sciences Inc
333 Lakeside Drive Foster City, CA 94404, USA
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
Dept. of Gastroenterology,Room No.3093, third
floor,New Delhi-110029, India New Delhi DELHI
911126588500
vins_ahuja@hotmail.com
Dr Shine Sadasivan
Amrita Institute of Medical Science and Research Center
3 rd Floor,Amrita Institute of Medical Science and Research Center, Amrita Lane, Elamakkara P O Edappally, Kochi, Ernakumalm, KERELA Ernakulam KERALA
91-9497556339
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
914424334455
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
Gastro OPD, 1 st Floor B J Medical College & Sassoon G Hospital, Sassoon Road, Pune, Maharashtra Pune MAHARASHTRA
ground Floor, Max Smart Super Speciality Hospital, Saket A Unit of Gujarmal Modi Hospital & Research Center for Medical Scienses, Mandr Marg, Press Encalve ROad, Saket,New Delhi, Delhi New Delhi DELHI
Dept. of Gastroenterology, Parel,Mumbai- 400012,
Maharashtra, India Mumbai MAHARASHTRA
912224143435
dkgt@rediffmail.com
Dr Chetan Mehta
Shree Giriraj Multispeciality Hospital
Department of Gastroenterology, Navjot Park Main Road,
150 Ft Ring Road,
Rajkot- 360002,
Gujarat, India Rajkot GUJARAT
912812587087
mehtacn@hotmail.com
Dr Rajiv Mehta
SIDS Hospital and Research Centre
Dept. of Gastroenterology, Ground Floor, A unit of SIDS Healthcare Pvt. Ltd., Off Ring Road, Near Shell Petrol Pump, Ring Road–Sosyo Circle Lane, Surat Surat GUJARAT
919879863510 912612800170 rmgastro@yahoo.com
Dr Mukesh Kumar Jain
SMS Medical College and Attached Hospital
Department of Gastroenterology, Vivekanand Marg, C-Scheme, Jaipur-302004, Rajasthan, India. Jaipur RAJASTHAN
919414323607 - drmukeshjaingastro@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
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
Institutional Ethics Committee,Sunshine Hospitals, Dr. Rohan Reddy
Approved
Institutional Ethics Committee- VGM Hospital, Dr VG Mohan Prasad
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
Manipal University Ethics Committee, Dr. B.Vishwanath Tantry
Approved
Manipal University Ethics Committee,Dr.Shiran 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, Surat Institute of Digestive Sciences, Dr.Rajiv Mehta
Approved
The Ethics Committee, SMS Medical College and Attached Hospital, 2nd Floor, New Administrative Block, SMS Medical College, JLN Marg, Jaipur – 302004, Rajasthan
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
1) Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
2) Must have met all eligibility criteria from a Gilead-sponsored UC parent protocol
3) Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
4) Females of childbearing potential must have a negative pregnancy test at Day 1 and must
agree to continued monthly pregnancy testing during use of filgotinib treatment
5) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6, for the duration described
6) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
ExclusionCriteria
Details
Key Exclusion Criteria:
• 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 subject 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 participants
• Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Change From Baseline in Components of Mayo Clinic Score or MCS
Baseline and up to 336 weeks
Target Sample Size
Total Sample Size="1000" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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 ulcerative colitis (UC).