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CTRI Number  CTRI/2018/03/012298 [Registered on: 05/03/2018] Trial Registered Prospectively
Last Modified On: 17/10/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   The post marketing clinical research on drug Infliximab in patients with moderate to severe Crohn’s disease 
Scientific Title of Study   A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of InfimabTM in patients with moderate to severe Crohn’s disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/PMS/2016/10 Version 2.0 Dated 04 May 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ajaykumar Yadav 
Designation  Head - Clinical Research (overall Trial Coordinator) 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701

Thane
MAHARASHTRA
400701
India 
Phone  9820804218  
Fax    
Email  Ajaykumar2.Yadav@relbio.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sachin Kagane 
Designation  Medical Monitor  
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701

Thane
MAHARASHTRA
400701
India 
Phone  9987885679  
Fax    
Email  Sachin.Kagane@relbio.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr. Ganesh Bagul 
Designation  Head - Clinical Operations 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701

Thane
MAHARASHTRA
400701
India 
Phone  9820617721  
Fax    
Email  ganesh1.bagul@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701 
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd  
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 22  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Ahuja  All India institute of medical science  Department of Gastroenterology, AIIMS, Ansari Nagar, New Delhi 110029
New Delhi
DELHI 		 9810707170

vineet.aiims@gmail.com 
Dr Kapil Kumar Sharma  Batra Hospital and Medical Research Centre  Department of Gastroenterology A Block Ground Floor Batra Hospital and Medical Research Centre 1 Tughlakabad Institutional Area Mehrauli Badarpur Road New Delhi 110062
New Delhi
DELHI 		 7023176653

drkapilsharma83@gmail.com 
Dr Ajit Sood  Dayanand Medical College and Hospital  Department of Gastroenterology, Civil Lines, Ludhiana - 141001
Ludhiana
PUNJAB 		 9815400718

ajitsood10@gmail.com 
Dr Mayank Gupta  Dhanwantri Hospital & Research Centre  Dhanvantari Life care Pvt. Ltd. New Sanganer Rd, Mansarovar Sector 6, Jaipur - 302020
Jaipur
RAJASTHAN 		 9887528604

dr.mayankgupta2010@gmail.com 
Dr Manjunath Patil  Dr. Satyaprakashs Centre for Digestive and Liver Diseases  6th Main Road, Chat Street, Door No. 229, 14th Cross Road,Vijaynagar, Bengaluru - 560040, Karnataka
Bangalore
KARNATAKA 		 9590917111

manju86sp@gail.com 
Dr Sumit Anand  EVAA Superspeciality Hospital  B28-29, Govind Marg, Tilak Nagar, Near Motidoongari Circle, Jaipur - 302004
Jaipur
RAJASTHAN 		 9929082000

dr.anandsumit@gmail.com 
Dr Rinkesh Kumar Bansal  Fortis Memorial Research Institute  Department of Gastroenterology and Hepato-Biliary Sciences, Sector-44, Opposite Huda City Centre Metro Station, Gurugram, Haryana - 122002
Gurgaon
HARYANA 		 9810417010

rinkesh.bansal@fortishealthcare.com 
Dr BSVV Ratnagiri  Govt. Siddhartha Medical College & Govt. General Hospital   1st Floor, Room NO 12 A, Central Diagnostics Block, Govt. Siddhartha Medical College Campus, Ring Road, Gunadala, Vijayawada - 520 008,
Krishna
ANDHRA PRADESH 		 9440068688

drratnagiri@gmail.com 
Dr Umesh Jalihal  Karnataka Gastro Center  748, 5th Main, Between Modi and Nagapura Main Road, Mahalakshmi Puram, WCR, Bengaluru - 560086
Bangalore
KARNATAKA 		 9945190666

kargastro@gmail.com 
Dr Abraham Koshy   Lakeshore Hospital and Research Centre Ltd  Ground Floor, Gastroenterology Department, NH-47, By-Pass, Nettoor P.O, Kochi - 682040
Ernakulam
KERALA 		 9495093420

koshyabe@yahoo.com 
Dr Mandar Diophode   Lifepoint Multispecialty Hospital Pvt. ltd.  1st floor, Room No 102 Sr. No. 145/1 Mumbai Bangalore Highway, Near Hotel Sayaji,Wakad, Pune- 411057
Pune
MAHARASHTRA 		 9850077168

mandardoiphode@yahoo.co.in 
Dr Vivek Bhatia  Maharaja Agrasen Hospital  Department of Gastroenterology,2nd floor, West Punjabi Bagh, New Delhi-110026,India
New Delhi
DELHI 		 9811028897

drvivekbhatia@yahoo.co.in 
Dr Rupender Prasad  Mahavir Hospital and Research Centre  Room No 1, Gastroenterology department, ground floor, Plot No. 10-1-1, Bhagwan Mahavir Marg, AC Guards, Masab Tank, Hyderabad, Telangana - 500004
Hyderabad
ANDHRA PRADESH 		 9849025475

rupendermathur@hotmail.com 
Dr P Kranthi Kumar  Mallareddy Narayana Multispeciality Hospital  Department of Gastroenterology, Suraram x Road, Quthbullapur Municipality, Jeedimetla
Hyderabad
TELANGANA 		 9502150814

krantikindia@gmail.com 
Dr Tryambak Samanta   Medical College and Hospital, Kolkata  Department of Medical Gastroenterology, 4th Floor, MCH buidling, 88 College Street, Kolkata - 7000073
Kolkata
WEST BENGAL 		 8777530352

drts.india@gmail.com 
Dr Rajendra Dhar  NIMS Medical College and Hospital  NIMS University Campus, Shobha Nagar, NH-11 C, Jaipur-Delhi Highway, Jaipur – 303121
Jaipur
RAJASTHAN 		 9414073962

rajendradhar60@gmail.com 
Dr Philip Abraham  P. D. Hinduja National Hospital and Medical Research Centre   Wing 1, First Floor, Room No 1104, Department - Gastroenterology , Veer Savarakar Marg, Mahim, Mumbai – 400016
Mumbai
MAHARASHTRA 		 9821231566

dr_pabraham@hindujahospital.com 
Dr Jayanta Samanta  Postgraduate Institute of Medical Education and Research (PGIMER)   Department of Gastroenterology, Nehru Hospital, Sector 12, Chandigarh – 160012
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
Dr Mukesh Kalla  S R Kalla Memorial Gastro & General Hospital  78-79 Dhuleshwar Garden Behind HSBC Bank Sardar Patel Marg, C-Scheme, Jaipur - 302001
Jaipur
RAJASTHAN 		 9829050622

drmkalla@rediffmail.com 
Dr Hemant Kumar Gupta  Samvedna Hospital  Department of Gastroenterology, 3rd Floor, B27/88G, New Colony, Ravindrapuri, Varanasi - 221005
Varanasi
UTTAR PRADESH 		 9415336365

hemantg26@yahoo.com 
Dr Hansraj Alva  Vinaya Hospital and Research Centre  Vinaya Poly Clinic, OPD Room, 1st Floor, P.O.No. 717, Karangalpady, Mangalore 575003
Dakshina Kannada
KARNATAKA 		 9343562622

hansrajalva2001@gmail.com 
Dr Praveen Mathew  Vydehi Institute of Medical Sciences and Research Centre  Department of Gastroenterology, No.82, EPIP area, Whitefield, Bengaluru-560068
Bangalore
KARNATAKA 		 9620880555

drpraveenmathew@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 22  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
Batra Hospital & Medical Research Centre Of CH. .AISHI Ram Batra Public Charitable Trust   Approved 
Dhanvantri Ethical Committee for Human Research Dhanvantri Life Care Pvt. Ltd., Jaipur  Approved 
Drug Trial Ethics Committee (DTEC), Ludhiana  Approved 
Ethics Committee Vinaya Hospital, Mangalore  Approved 
IEC, Fortis Memorial Research Institute, Gurugram  Approved 
Institute ethical committee All India institute of medical science   Approved 
Institutional Ethics Committee Bhagwan Mahavir Medical Research Centre, Hyderabad  Approved 
Institutional Ethics Committee for Human Research, Medical College, Kolkata  Approved 
Institutional Ethics Committee PD Hinduja Hospital & Medical Research Centre, Mumbai  Approved 
Institutional Ethics Committee Siddhartha Medical College & Govt. General Hospital, Vijaywada  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital, New Delhi  Approved 
Institutional Ethics Committee, NIMS University Rajasthan, Jaipur  Approved 
Institutional Ethics Committee, NIMS University Rajasthan, Jaipur  Approved 
Karnataka Gastro Center Ethics Committee, Bengaluru  Approved 
Lakehsore Ethics Committee, Kochi  Approved 
Life Point Research Ethics Committee, Pune  Approved 
Malla Reddy Medical College For Women Institutional Ethics Committee, Hyderabad  Approved 
Pranav Diabetes Center Ethics Committee, Bengaluru  Approved 
S R Kalla Memorial Ethical Committee For Human Research, Jaipur   Submittted/Under Review 
Samvedna Hospital Ethics Committee, Varanasi  Approved 
Vydehi Institutional Ethics Committee, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K509||Crohns disease, unspecified, Patients with moderate to severe Crohn’s disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infliximab  Infimabâ„¢ 5 mg/kg will be administered as intravenous infusion over a period of not less than 2 hours in all eligible patients  
Comparator Agent  NA  NA As it is a single arm open label study  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 65 yrs Both inclusive

Patient with confirmed diagnosis of Crohns disease since at least 6 months and eligible to be administered infliximab as per prescribing information of Infliximab innovator.

Patients with moderate to sever active Crohns Disease defined as Crohns disease activity index (CDAI) score of at least 220

Women with Childbearing potential must agree to use adequate contraception.

Patient will to provide written informed consent.  
 
ExclusionCriteria 
Details  Patients with hypersensitivity to infliximab or any of its components

Pregnant or lactating females

Presence of serious or active infection due to bacteria, fungi, viruses or other
opportunistic pathogens

History of serious infection, which caused hospitalization within 6 months prior to
randomization or other severe or chronic infection (such as sepsis, abscess or
opportunistic infections, invasive fungal infection such as histoplasmosis, or a history
of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis
without sufficient documentation of complete resolution following treatment.

Infection requiring parenteral antibiotic treatment within 4 weeks of randomization.

Patients with history of any malignancy including lymphomas or presence of any
premalignant lesions

Patients with heart failure (New York Heart Association class III or IV)

Patients with known hematological disorders, demyelinating disease or lupus-like
syndrome

Patients with clinically significant liver disease

Known cases of HIV, Hepatitis B or Hepatitis C infection

Active TB. Also excluded are subjects who have evidence of latent TB [evidence of
tuberculosis based on chest X rays, tuberculin skin (Mantoux) test or other
tuberculosis test performed during screening] without adequate therapy for TB
completed prior to first infusion of Study Medication. Also excluded are subjects with
evidence of an old or latent TB infection without documented adequate therapy, if
they will not be treated with antitubercular therapy during the study. Subjects with a
current close contact with an individual with active TB will also be excluded.
Additionally, subjects who have completed treatment for active TB within the previous
2 years are explicitly excluded from the study. Subjects with a household member
who has a history of active pulmonary TB, which has been treated, should have had
a thorough evaluation for TB prior to study enrolment as recommended by a local
infectious disease specialist or published local guidelines of TB control agencies.
Also excluded are subjects with opportunistic infections including, but not limited to,
evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or
atypical mycobacterial infection, etc., within the previous 6 months.
12. Patients with any condition that might make it difficult for patients to participate in the
study or that might affect interpretation of results of the study, at the discretion of
Investigator.

Participation in any clinical study of an investigational product within previous 3
months.

Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
disease that renders the patient incapable of participating in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidences of adverse events occurring during the study   Incidences of adverse events occurring during the study till week 14 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Crohns disease activity index (CDAI) from base line to week 14   week 14  
Clinical Response rate at week 14  week 14 
Remission rate at week 14   week 14 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/03/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This is a prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of InfimabTM in 100 patients with moderate to severe Crohn’s disease.

InfimabTM is a similar biological to innovator product developed by Reliance Life Sciences Pvt. Ltd. A phase III study conducted in patients with active rheumatoid arthritis on a stable dose of methotrexate demonstrated the comparable efficacy and safety profile of InfimabTM and the Innovator product.

InfimabTM has been approved by DCGI for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and ulcerative colitis.

This is prospective, multi-centre, open label, phase IV study has been designed to evaluate the safety and efficacy of InfimabTM in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. As per the clinical evidence gathered patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue infliximab in these patients. Hence, the efficacy endpoints will be assessed at Week 14.

Study Population: Male or female patients aged between 18 to 65 years (both inclusive) with moderate to severe Crohn’s disease (CDAI score of at least 220).


 
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