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CTRI Number  CTRI/2009/091/000138 [Registered on: 26/05/2009]
Last Modified On: 08/08/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
An Open-Label Study of (MLN0002) in Patients With Ulcerative Colitis and Crohns Disease 
Scientific Title of Study
Modification(s)  
A Phase 3, Open-Label Study to Determine the Long-Term Safety and Efficacy of (MLN0002) in Patients With Ulcerative Colitis and Crohns Disease Acronym (GEMINI III)  
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2008-002784-14  EudraCT 
C13008 Protocol Amendment 8 dated 15 February 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Shoibal Mukherjee 
Designation  Vice President, Medical  
Affiliation  Quintiles Research (India) Pvt. Ltd. 
Address  8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana India - 122002

Gurgaon
HARYANA
122002
India 
Phone  91-7838652395  
Fax    
Email  shoibal.mukherjee@quintiles.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Suchela Srivatsa 
Designation  Director – Clinical Operations  
Affiliation  Quintiles Research (India) Pvt. Ltd 
Address  301-A-1, Leela Business Park MV Road, Andheri East, Mumbai 400059

Mumbai
MAHARASHTRA
400 059
India 
Phone  91-9820712114  
Fax  91-22-56774343  
Email  suchela.srivatsa@quintiles.com  
 
Source of Monetary or Material Support
Modification(s)  
Millennium Pharmaceuticals, Inc., 35 Landsdowne Street, Cambridge, MA 02139 
 
Primary Sponsor
Modification(s)  
Name  Millennium Pharmaceuticals Inc  
Address  Landsdowne Street Cambridge MA  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Nil   
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KA Ramkrishna  AHERF, Apollo Hospitals,   Near Blood bank,,Apollo health city, Jubilee Hills, -500 033
Hyderabad
ANDHRA PRADESH 
040-3132004
040-23324255
apollohyd@apollohospital.com 
Dr. Vineet Ahuja  All India Institute of Medical Sciences,   Department of Gastroenterology,Room no. 3093, 3rd floor, Teaching block,,Ansari nagar, -110029
New Delhi
DELHI 
011-26589070
011- 26588663
vins_ahuja@hotmail.com 
Dr. P. Murli Krishna  Andhra Medical College,  RP ward, King George Hospital, ,Maharanipeta, -530 002
Visakhapatnam
ANDHRA PRADESH 
0891-3203340
0891-2569080
muralikrishna63@yahoo.com 
Dr. S.M. Ravindranath  Apollo BGS Hospitals,   Adhichunchanagiri Road,Kuvempunagar, -570023
Mysore
KARNATAKA 
0821- 2461082
0821- 2460870
ravindranath_S@apollohospitals.com 
Dr. Mahesh Goenka  Apollo Gleneagles Hospital  58, Canal Circular Road,-700054
Kolkata
WEST BENGAL 
033-23203040
033-23201739
dr_mgoenka@yahoo.co.in 
Dr. T.V. Sekar  Apollo Hospital Education & Research foundation  Lake View Road, ,K.K. Nagar, -625020
Madurai
TAMIL NADU 
0452- 2581157
0452-4752242
scrcmdu@yahoo.co.in 
Dr. Shravan Kumar Bohra  Apollo Hospital,   Plot 1 A, Bhat GIDC Estate, ,Gandhi nagar,-382428
Ahmadabad
GUJARAT 
079- 66701802
079-40151153
sgbohra@hotmail.com 
Dr. S. Ganesh  Apollo Speciality Hospital,  No. 320 Padma Complex,Mount Road, Teynampet, -600035
Chennai
TAMIL NADU 
044-24331741
044- 24362424
gastroganesh@yahoo.co.in 
Dr. Nageshwar Reddy  Asian Institute of Gastroenterology,   6-3-661, Somajiguda, ,-500 082
Hyderabad
ANDHRA PRADESH 
040-23378888
040- 23324255
dr_rupa_banerjee@hotmail.com 
Dr. Deepak Amarapurkar  Bombay Hospital & Medical Research Centre  MRC building, ,2nd floor,-400020
Mumbai
MAHARASHTRA 
022-2067676
022-22050589
amarapurkar@gmail.com 
Dr. Abhijit Chandra  Chatrapati Shau Maharaj Medical University  Department of Surgical Gastroenterology,New Surgical Block, Shahmina Road, Chowk, -226 003
Lucknow
UTTAR PRADESH 
0522- 2257540
0522- 2256116
abhijitchandra@hotmail.com 
Dr. Bailuru Vishwanath Tantry  Kasturba Medical College and Hospital  Ambedkar Circle,,-575001
Bangalore
KARNATAKA 
0842-2445858
0842- 2425092
tantrybv@gmail.com 
Dr. Bharat Kalambe  King Edward Memorial Hospital and Research Centre,  Rasta Peth,,-411011
Pune
MAHARASHTRA 
020- 26141177
020-66057403
bkalambe@gmail.com 
Dr. Abraham Koshy  Lakeshore Hospital and Research Centre  NH47 Bypass, Maradu, ,Neettoor P.O., -682304

 
0484- 2701032
0484-2701996
koshyabe@yahoo.com 
Dr. Umesh Jalihal  M. S. Ramaiah Medical College and Hospital,  M. S. R. Nagar,,M. S. R. I. T. Post,-560054
Bangalore
KARNATAKA 
080- 22183048
080-22183012
drumeshj@yahoo.com 
Dr Ramesh Kumar  Medwin Hospitals,   Raghava Ratna Towers,,Chirag Ali lane, Nampally, -500 001
Hyderabad
ANDHRA PRADESH 
040-23206666
040-23203565
bhashyakarla_rk@yahoo.co.in 
Dr. Mukesh Sarna  Monilek Hospital & Research Center  Sector 4, ,Jawahar Nagar-302004
Jaipur
RAJASTHAN 
0141-302004
0141- 2652181
mukesh_sarna@hotmail.com 
Dr. Mohammed Aejaz Habeeb  Owaisi Hospital and Research Centre,   Kanchan Bagh, ,Santoshnagar, -500058
Hyderabad
ANDHRA PRADESH 
040- 4442954
040-4752242
aejazhabeeb@hotmail.com 
Dr. Vinay Thorat  Poona Hospital and Research Centre,   27, Sadashiv Peth,-411 013
Pune
MAHARASHTRA 
020-24331706
020-26137617
drvinaythorat@gmail.com 
Dr VG Mohan Prasad  VGM Hospital  Institute of Gastroenterology, 2100 Trichy Road, Rajalakshmi Mills Stop, Coimbatore - 641005
Coimbatore
TAMIL NADU 
09952270817
0442211216
drvgm@rediffmail.com 
Dr. Ravi B. Shankar  Yashoda Hospitals,  Hari hara Kala Bhavan,S.P. Road, -500 003

 
040-27713333
040-277039999
j_may_24@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 21  
Name of Committee  Approval Status 
Central Ethic Committee, Apollo Hospitals Group, Apollo Hospitals Educational and Research Foundation, Hyderabad- Dr KA Ramkrishna   Approved 
Central Ethic Committee, Apollo Hospitals Group, Apollo Hospitals Educational and Research Foundation, Hyderabad- Dr. Mahesh Goenka  Approved 
Central Ethic Committee, Apollo Hospitals Group, Apollo Hospitals Educational and Research Foundation, Hyderabad- Dr. S. Ganesh  Approved 
Central Ethic Committee, Apollo Hospitals Group, Apollo Hospitals Educational and Research Foundation, Hyderabad- Dr. S.M. Ravindranath  Approved 
Central Ethic Committee, Apollo Hospitals Group, Apollo Hospitals Educational and Research Foundation, Hyderabad- Dr. Shravan Kumar Bohra   Approved 
Central Ethic Committee, Apollo Hospitals Group, Apollo Hospitals Educational and Research Foundation, Hyderabad- Dr. T.V. Sekar   Approved 
Coimbatore Ethics Committee, KG Hospital, Coimbatore- Dr VG Mohan Prasad  Approved 
Ethical Review Board, M. S. Ramaiah Medical College and Hospital, Bangalore- Dr. Umesh Jalihal  Approved 
Ethics committee, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad - 500 082- Dr. Nageshwar Reddy  Approved 
Ethics Committee, Bombay Hospital & Medical Research centre, MRC building, 2nd floor, Mumbai - 400020- Dr. Deepak Amarapurkar   Approved 
Ethics committee, KEM Hospital RC Rasta Peth, Pune - 411011- Dr. Bharat Kalambe   Approved 
Ethics Committee, Poona Hospital and Research Centre, Pune- Dr. Vinay Thorat  Approved 
Institutional Ethics committee, All India Institute of Medical science, Ansari nagar, New Delhi - 110029- Dr. Vineet Ahuja  Approved 
Institutional Ethics Committee, Andhra Medical College, Visakhapatnam - Dr. P. Murli Krishna  Approved 
Institutional Ethics Committee, Chatrapati Shau Maharaj Medical University, Lucknow- Dr. Abhijit Chandra  Approved 
Institutional Ethics Committee, KMC, Mangalore- Dr. Bailuru Vishwanath Tantry   Approved 
Institutional Ethics Committee, Medwin Hospitals, Hyderabad- Dr Ramesh Kumar   Approved 
Institutional Ethics Committee, Monilek Hospital and Research Centre, Jaipur- Dr. Mukesh Sarna   Approved 
Institutional Ethics Committee, Owaisi Hospital and Research Centre, Hyderabad- Dr. Mohammed Aejaz Habeeb   Approved 
Institutional Ethics Committee, Yashoda Hospitals, Secunderabad- Dr. Ravi B. Shankar   Approved 
Lakeshore Ethics Committee, Cochin - Dr. Abraham Koshy   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Ulcerative Colitis and Crohns Disease  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  MLN0002  Enrolled patients will receive MLN0002 every 4 weeks, starting at Week 0, for up to 100 weeks. The dosing period will be followed by a 16-week post-treatment observation and safety assessment period. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Previous treatment in Study C13004, Study C13006 or Study C13007 that, in the opinion of the investigator, was well tolerated
2. May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol
 
 
ExclusionCriteria 
Details  1. Development of any new, unstable, or uncontrolled disease 
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To determine adverse events, serious adverse events, results of standard laboratory tests and ECGs, time to major IBD-related events (hospitalizations, surgeries or procedures), and improvements in quality of life.  100 week 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="25" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
01/10/2009 
Date of First Enrollment (Global)  01/05/2009 
Estimated Duration of Trial
Modification(s)  
Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
Not Yet 
Brief Summary
Modification(s)  
This multicenter, 2-year open-label study will collect data on the occurrence of important clinical safety events resulting from chronic (MLN0002) administration. In India, 100 patients are planned to be enrolled. The study under Protocol No.: C13008 is a open label study, wherein the subjects have opportunity to enroll after completion of the C13006 or C13007 protocols. Also, in case there is any early withdrawal due to any reason as per the protocol in C13006/07, still the subject has option of enrolling into C13008. As of May 25, 2009, globally no subjects are got enrolled into this protocol. In India, the recruitment for studies under Protocol No.: C13006 and C13007 has not yet started (upto May 25, 2009). Hence, no subjects are enrlolled in study under Protocol No.: C13008. 
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