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CTRI Number  CTRI/2015/10/006247 [Registered on: 12/10/2015] Trial Registered Prospectively
Last Modified On: 01/03/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Multicentre, open label and observational study 
Study Design  Other 
Public Title of Study   A prospective, Post Marketing Surveillance study of omalizumab in Chronic Spontaneous Urticaria  
Scientific Title of Study   A prospective, Post Marketing Surveillance study to study the safety and effectiveness of omalizumab in Indian patients with Chronic Spontaneous Urticaria refractory to standard of care 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CIGE025EIN01, Version 01 dated 03 Feb 2016  Protocol Number 
 
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 Venkatramana Nagire 
Designation  Medical Advisor 
Affiliation  Novartis Healthcare Pvt. Ltd 
Address  Novartis Healthcare Pvt. Ltd.,6th Floor, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400018, INDIA.
Novartis Healthcare Pvt. Ltd.,6th Floor, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400018, INDIA.
Mumbai
MAHARASHTRA
400018
India 
Phone  24958562  
Fax    
Email  venkatramana.nagire@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Venkatramana Nagire  
Designation  Medical Advisor 
Affiliation  Novartis Healthcare Pvt. Ltd 
Address  Novartis Healthcare Pvt. Ltd.,6th Floor, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400018, INDIA.
Novartis Healthcare Pvt. Ltd., Medical Dept., Sandoz House, 6th Floor, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400018, INDIA.
Mumbai
MAHARASHTRA
400018
India 
Phone  24958562   
Fax    
Email  venkatramana.nagire@novartis.com  
 
Source of Monetary or Material Support  
Novartis Healthcare Private Limited 
 
Primary Sponsor  
Name  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Pvt. Ltd., Medical Dept., Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018. INDIA. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Novartis Healthcare Pvt Ltd  Novartis Healthcare Pvt. Ltd., Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018 INDIA  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Radha Shah  Apollo Hospitals  Jubilee Hills, Hyderabad-500096, Telangana, India
Hyderabad
ANDHRA PRADESH 		 9849078839

drradhashah@gmail.com 
Dr Manoj parekh  Bhagwan Mahaveer Jain Hospital  No.17, Millers Road, Vasanthnagar, Bengaluru, Karnataka 560052, India
Bangalore
KARNATAKA 		 09845225459

drmanojparekh@gmail.com 
Dr Abhishek De  Calcutta National Medical College and Hospital  Calcutta National Medical College and Hospital, 32, Gorachand road, Kolkata, West Bengal-700014, India
Kolkata
WEST BENGAL 		 09903275551

dr_abhishek_de@yahoo.co.in 
Dr Ashish Jagati  Civil Hospital   D Block,room no.-139, wing no.3,skin OPD,Ahmedabad, Gujarat 380016, India
Ahmadabad
GUJARAT 		 9825025640

jagatiashish@gmail.com 
Dr Kiran Godse  D. Y. Patil Hospital  Dr. D. Y. Patil Hospital, Sector 5, Nerul East, Navi Mumbai,Maharashtra 400706, India.
Mumbai
MAHARASHTRA 		 9322266687

drgodse@gmail.com 
Dr Ramesh Bhat  Father Muller Medical College Hospital  Kankanady, Mangalore-575002, India
Dakshina Kannada
KARNATAKA 		 9845084224

rameshderma@gmail.com 
Dr Soumya Debta  IPGME&R/SSKM Hospital  No. 244, AJC Bose Road, Kolkata-700020, West Bengal, India
Kolkata
WEST BENGAL 		 07044004123

soumyadebta@gmail.com 
Dr Nandini AS  Kempegowda Institute of Medical Sciences  OPD building, B Block, K.R.Road, V.V.Puram, Bangalore-04 , India
Bangalore
KARNATAKA 		 9886829579

drnandinias2002@yahoo.co.in 
Dr Uma Chakravadhanula  Krishna Institute of Medical Sciences  1-8-31/1, Minister Rd, Krishna Nagar Colony, Begumpet, Secunderabad, Telangana 500003, India
Hyderabad
ANDHRA PRADESH 		 09490752772

uma.cvd@gmail.com 
Dr Ajita Bagai  Max Super Speciality Hospital  Max Super Speciality Hospital, 1,2, Press Enclave Road, Saket, New Delhi, Delhi 110017, India
New Delhi
DELHI 		 9810646989

ajitakakkar@gmail.com 
Dr Vinay Singh  Max Super Speciality Hospital  FC-50, C & D Block, Shalimar Bagh, New Delhi, Delhi 110088, India
New Delhi
DELHI 		 09811066509

drvinay522@yahoo.com 
Dr Vijaya Bhaskar Mallela  OMNI hospitals  H.NO- 11-9-46, OPP.PVT market,Kothapet Cross roads, Dilshuknagar, Hyderabad-35, India
Hyderabad
ANDHRA PRADESH 		 09848425425

drvijaymallela@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Bhagwan Mahaveer Jain Hospital,   Approved 
Divine Ethics Committee, Omni Hospitals,   Approved 
Ethics Comittee, Calcutta National Medical College  Approved 
Ethics Committee, Apollo Hospitals  Approved 
Ethics Committee, D.Y.Patil Hospital  Approved 
Father Muller Institutional Ethics Committee  Approved 
Institutional Ethics Committee Max Super Speciality Hospital Saket( a unit of Devki Devi Foundation)  Submittted/Under Review 
Institutional Ethics Committee, B.J.Medical College and civil hospital  Submittted/Under Review 
IPGME&R Research oversight committee institute of Post Graduate Medical Education and Research  Approved 
KIMs college,Banashankari 2nd stage bangalore 560070  Approved 
KIMS foundation and research centre  Submittted/Under Review 
Max Healthcare Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Xolair in CSU,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. CSU patients prescribed with omalizumab as per approved package insert and who are not treated with omalizumab 6 months prior to entering the study.
2. Patients willing to participate in the study by providing written informed consent. 
 
ExclusionCriteria 
Details  1.Contraindication as per PI.

2.Patients simultaneously participating in other studies
Pregnant women should not be included except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To obtain safety data from Indian patients with Chronic Spontaneous Urticaria refractory to standard of care treated with omalizumab  study duration up to Month 24 
 
Secondary Outcome  
Outcome  TimePoints 
Collect effectiveness data during real-world use of omalizumab in CSU  study duration up to Month 24 
Provide real-world QoL data in patients with CSU treated with omalizumab  study duration up to Month 24 
Assess CSU Indian patient’s journey treated with omalizumab in real world scenario.   study duration up to Month 24 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/11/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   This is a 2 year PMS study to describe the safety and effectiveness of omalizumab in patients treated according to local regulations and standards of clinical practice. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The present post marketing surveillance (PMS) study is mandated by Indian health authority (HA) as a part of conditional approval to market authorization of omalizumab in CSU refractory to standard of care. The Health Authorities have mandated “PMS data for 2 years” in their approval letter. Due to non- availability of Indian data for Omalizumab in CSU patients, marketing authorization of the same has been granted condition to “submission of PMS data for 2 years”.

Thus the present prospective Post marketing Surveillance (PMS) study will be conducted to study the effect of omalizumab in Indian patients with Chronic Spontaneous Urticaria refractory to standard of care under current real-life medical practice as mandated by HA. The study evaluates safety (primary objective) and effectiveness (secondary objective) of omalizumab in CSU refractory to standard of care.  

 
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