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CTRI Number  CTRI/2014/04/004518 [Registered on: 02/04/2014] Trial Registered Retrospectively
Last Modified On: 21/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess long term efficacy, safety, tolerability and usability of Secukinumab in patients with active Rheumatid Artheritis 
Scientific Title of Study   A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CAIN457F2311 V00 dated 07-Jun-12  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  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Novartis Healthcare Private Limited,  
Address  Medical Department, Sandoz House, Shiv Sagar Estate
Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Novartis Healthcare Private Limited,  
Address  Medical Department, Sandoz House, Shiv Sagar Estate
Dr. Annie Besant Road, Worli, Mumbai

MAHARASHTRA
400018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Basel, Switzerland 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  Medical Dept, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai- 400018 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     Argentina
Brazil
Colombia
Czech Republic
Dominican Republic
Ecuador
Germany
Greece
Guatemala
India
Italy
Panama
Portugal
Republic of Korea
South Africa
United States of America  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajit Nalawade  Inamdar Multispecialty Hospital  Department of Rheumatology, Inamdar Multispecialty Hospital & Research Center, Sr. No. 15, Fatimanagar, Behind KPCT Mall, Pune 411 040.
Pune
MAHARASHTRA 		 020-41236660

dr.ajitnalawade@gmail.com 
DrSarathchandra Mouli Veeravalli  Krishna Institute of Medical Sciences  Deaprtment of Rheumatology,Krishna Institute of Medical Sciences,1-8-31/1, Minister Road, Secunderabad
Hyderabad
ANDHRA PRADESH 		 9866000685

sarath10@hotmail.com 
Dr Rajiv Gupta  Malpani Multispeciality Hospital  Deaprtment of Rheumatology, Malpani Multispeciality Hospital,VKI,Sikar Road, Jaipur
Jaipur
RAJASTHAN 		 9460891205

rajiv-jpr@indiatimes.com 
Dr Girish Bhatia  Medipoint Hospitals Pvt. Ltd  Department of Rheumatology,Medipoint Hospitals Pvt. Ltd,241/1, New D. P. road, Aundh
Pune
MAHARASHTRA 		 7387003636

drbhatia.pentagon@gmail.com 
Dr Atul Kakar  Sir Ganga Ram Hospital  Department of Rheumatology,Sir Ganga Ram Hospital Marg, Old Rajinder Nagar
New Delhi
DELHI 		 9811110802

atulkakar@hotmail.com 
DrSarvajeet Pal  Sumana Hospital  Department of rheumatology,Sumana Hospital,Plot No 687,688, Vivekananda NagarColony,Kukatpally, Hyderabad-500072 India
Hyderabad
ANDHRA PRADESH 		 9848091533

palsarvajeet@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethical Committee Inamdar Multispeciality Hospital, Dr Ajit Nalawade, Inamdar Multispeciality Hospital  Approved 
ETHICS COMMITTEE,SIR GANGA RAM HOSPITAL, Dr Atul Kakar  Approved 
Institutional Ethics Committee, Jaipur, Dr Rajiv Gupta  Approved 
Institutional Ethics Committee, KIMS, Veeravali  Approved 
Penta-Med Ethics Committee, Pune, Dr Girish Bhatia  Approved 
Sumana Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Active Rheumatoid arthritis, (1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo 75 mg and placebo 150 mg   Once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 16 or week 24 as sc injection depend on patient responder or non responder status basesd on tender & swollen joint count. After that the Placebo arm patients will be shifted to active Secukinumab 75 mg or 150 mg arm. The same therapy will be continued from week 16 or week 24 till week 256. 
Intervention  secukinumab (AIN457)75 mg  secukinumab (AIN457)75 mg plus placebo 150 mg subcutaneously once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 256. Total duration of therapy: 256 weeks from baseline 
Intervention  Secukinumab 150 mg  Secukinumab 150 mg plus placebo 75 mg once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 256 as subcutaneous injection. Total duration of therapy: 256 weeks from baseline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subject must be able to understand and communicate with the investigator and
comply with the requirements of the study and must give a written, signed and
dated informed consent before any study assessment is performed
2. Male or non-pregnant, non-lactating female subjects at least 18 years of age
3. Presence of RA classified by ACR 2010 revised criteria (see Appendix 2) for at
least 3 months before screening
• At Baseline: Disease activity criteria defined by ≥6 tender joints out of 68 and ≥ 6
swollen joints out of 66
WITH at least 1 of the following at screening:
- Anti-CCP antibodies positive OR
- Rheumatoid Factor positive
AND WITH at least 1 of the following at screening:
- hsCRP ≥ 10 mg/L OR
- ESR ≥28 mm/1st hr
4. Subjects must have been taking at least one anti-TNF-α agent such as etanercept,
adalimumab, infliximab, certolizumab or golimumab given at an approved dose for
at least 3 months before randomization and have experienced an inadequate
response to treatment or have been intolerant to at least one administration of an
anti-TNF-α agent 
 
ExclusionCriteria 
Details  1. Chest x-ray or MRI with evidence of ongoing infectious or malignant process,
obtained within 3 months prior to screening and evaluated by a qualified physician
2. RA subjects functional status class IV according to the ACR 1991 revised criteria
(see Appendix 3)
3. Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
morphine)
4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17
or IL-17 receptor
5. Use of any investigational drug and/or devices within 4 weeks before
randomization, or a period of 5 half-lives of the investigational drug, whichever is
longer 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to
placebo in patients with active RA based on the proportion of patients achieving an ACR20
response. 		 52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior
to placebo in patients with active RA based on the proportion of subjects achieving an
ACR50 response 		 upto 52 weeks 
To demonstrate the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to
placebo with respect to the improvement (change) from baseline in HAQ-DI 		 upto 52 weeks 
 
Target Sample Size
Modification(s)  		 Total Sample Size="242"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   27/02/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/10/2012 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A phase 3 trial to demonstrate  the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents.

Planned no. of patients from India: 25

FPFV achived on 27 Feb 2014 from India

 
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