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CTRI Number  CTRI/2021/12/038694 [Registered on: 16/12/2021] Trial Registered Prospectively
Last Modified On: 28/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Secukinumab Open Label Roll-over Extension Protocol 
Scientific Title of Study   An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2020-004284-98  EudraCT 
CAIN457A02001B Version 00 Dated 23 Sep 2020  Protocol Number 
NCT04638647  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  6 & 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai – 400051,India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
Brazil
Bulgaria
Colombia
Czech Republic
Egypt
France
Greece
Guatemala
India
Malaysia
Mexico
Norway
Poland
Republic of Korea
Russian Federation
South Africa
Spain
Sweden
United States of America  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uma Kumar  All India Institute of Medical Sciences  Department of Rheumatology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi-110029
New Delhi
DELHI 		 9868397253

umaakumar@yahoo.co.in 
Dr Praveen Jadhav  Assured Care Plus Hospital  4th & 5th Floor, Star Plus Complex, Near Muktidham Temple, Nashik road, Nashik 422101, Maharashtra, India.
Nashik
MAHARASHTRA 		 91-9822055612

drpraveenjadhav@rediffmail.com 
Dr Chandrashekara Srikantiah  ChanRe Rheumatology & Immunology Center & Research  No-414/65, 20th Main, West of Chord Road, 1st Block, Rajajinagar, Bengaluru-560010
Bangalore
KARNATAKA 		 9845071151

chandrashekara_s@yahoo.com 
Dr Jyotsna Oak  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Department of Rheumatology and Medicine, Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai, Maharashtra 400053, India
Mumbai
MAHARASHTRA 		 91-9324717618

JYOTSNA.OAK@kokilabenhospitals.com 
Dr Liza Rajasekhar  Nizams Institute of Medical Sciences  C/O Millennium Block, 4th Floor, Dept. of Clinical Immunology and Rheumatology, Panjagutta Road, Panjagutta, Hyderabad, Telangana-500082
Hyderabad
TELANGANA 		 9391008618

lizarajasekhar@gmail.com 
Dr Romi Shah  Shalby Hospital  Near Navyug College, Rander Road, Adajan, Surat-359009, Gujarat, India
Surat
GUJARAT 		 91-8238004052

romi25389@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics committee-Shalby Ltd-Surat, Dr. Romi Shah  Approved 
Institutional Ethics Committee ChanRe Rheumatology & Immunology Center & Research, Dr. Chandrashekara Srikantiah  Approved 
Institutional Ethics Committee, Dr. Jyotsna Oak  Approved 
Instutional Ethics Committee AIIMS, New Delhi, Dr. Uma Kumar  Approved 
NIMS Institutional Ethics Committee, Dr. Liza Rajasekhar  Approved 
Yash Socielys Suiala Birla Hospital Ethics Committee, Dr. Praveen Pratap Jadhav  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M148||Arthropathies in other specified diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Secukinumab  Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFS) for s.c. injection, once every 4 weeks for 2 years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Signed informed consent must be obtained before any assessment is performed.
2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
3. Participant has completed the parent study until end of the follow-up period (unless otherwise specified in the parent protocol).
4. Participant is deriving benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement.
5. Participant is unable to obtain the marketed secukinumab formulation due to unavailable local registration or reimbursement. 
 
ExclusionCriteria 
Details  1. Participant has discontinued study treatment in the parent protocol for any reason.
2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Long term safety as assessed by occurrence of AEs/SAEs  Long term safety as assessed by occurrence of AEs/SAEs (Time frame- Up to 2 years) 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="646"
Sample Size from India="45" 
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   Phase 4 
Date of First Enrollment (India)   30/12/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/12/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation. 
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