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CTRI Number  CTRI/2009/091/000874 [Registered on: 13/01/2010]
Last Modified On: 01/10/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and Efficacy of AIN457 in Behçet's Patients With Posterior or Panuveitis (SHIELD) 
Scientific Title of Study   A 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CAIN457C2303  Protocol Number 
NCT00995709  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 

Not Applicable
N/A

India 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Muruganananthan K 
Designation  Head Clinical Development 
Affiliation   
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India 
Phone  02224958533  
Fax  02224954112  
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Murugananthan K 
Designation  Head Clinical Development 
Affiliation   
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India 
Phone  02224958533  
Fax  02224954112  
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Basel, Switzerland 
 
Primary Sponsor
Modification(s)  
Name  Novartis Health care Private Limited 
Address  Novartis India Limited 5th Floor, Sandoz House, Dr Annie Beseant Road, Worli,Mumbai 400018 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. S. Natarajan  Aditya Jyot Hospital Pvt Ltd  Plot No 153, Road no.9,,Major Parmeshawaran road opp., SIWS college, Wadala, -400 031
Mumbai
MAHARASHTRA 		 022- 24181001
022-24177630
natyforyou@yahoo.co.in 
Dr. Rajvardhan Azad  AIIMS   Room No: 486, 4th floor office block, Dr. R P Centre for Ophthalmic sciences,,Ansari Nagar, -110029
New Delhi
DELHI 		 011-26593187
011-26588919
rajvardhanazad@hotmail.com 
Dr. S. R Rathinam  Aravind Eye Hospital  Uveitis Services, 1,,Anna Nagar, -625020
Madurai
TAMIL NADU 		 0452-4356100
0452-2530984
rathinam@aravind.org 
Dr. Thomas Cherian  Little Flower Hospital and Research centre  2nd floor Ophthalomology building,PB No: 23-683 572

 		 0484-2453223

suman.alexander@gmail.com 
Dr. Jyotirmay Biswas  Shankara Nethralaya  Vision research Foundation,18 College Road-600 006
Chennai
TAMIL NADU 		 044-28271616
044-28254180
drjb@snmail.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
All India Institute of Medical Sciences New Delhi Institution Ethics Committee  Approved 
ARAVIND EYE CARE SYSTEM  Approved 
Ethics Committee, ADITYA JYOT EYE HOSPITAL PVT. LTD  Approved 
Ethics Subcommittee, Vision Research Foundation  Approved 
Little Flower Hospital Clinical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Behcet Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biological: AIN457   AIN457C 300 mg every 2 week dosage regimen 
Intervention  Biological: AIN457  AIN457C 300 mg monthly dosage regimen 
Comparator Agent  Placebo   Placebo Comparator 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Day(s)
Age To  0.00 Day(s)
Gender  Both 
Details  Male and female subjects greater than18 years of age
2. Patients with Behcets disease and with a history of recurrent uveitis in a least one eye.
Patients with both active (experiencing an acute exacerbation) and quiescent (in between
exacerbations) posterior uveitis or panuveitis secondary to Behcets disease at the time of
screening are eligible for the study. The diagnosis of Behcets disease lies in the judgment of
the investigator. Criteria for the diagnosis of Behcets disease according to the International
Uveitis Study Group criteria and the Behcets Disease Research Committee criteria (complete
or incomplete type) are provided Appendix 2.
3. Documented evidence of greater than2 recurrent exacerbations of either posterior uveitis or panuveitis in
the study eye within the past 6 months (this could include the current exacerbation for
patients having an acute exacerbation at screening). Exacerbations fulfilling the study
inclusion criteria must have one or more of the following recorded in the patients medical
record for each recurrent exacerbation.
a. greater than2+ vitreous haze with less than2+ anterior chamber cell grade (posterior uveitis) or greater than2+
vitreous haze with greater than2+ anterior chamber cell grade (panuveitis)
b. presence of retinal infiltrates or vasculitis or hemorrhages
c. documented greater than10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed
to ocular inflammation secondary to the recurrent exacerbation of Behcets disease.
4. Requirement for either of the following immunosuppressive therapies for at least 3 of the past
6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to
Behcets disease
a. Prednisone or equivalent greater than10 mg daily
b. The need for at least greater than1 periocular injection or greater than1 intravitreal corticosteroid injection in
the study eye within the past 6 months (the last injection must have not been given
within 6 weeks of screening)
c. Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil,
mycophenolic acid or methotrexate either as monotherapy or in combination with or
without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide
are not eligible for the study.)
Patients not meeting the above specified criteria for immunomodulatory therapies are eligible
for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by
the study investigator
 
 
ExclusionCriteria 
Details  . Subjects with infectious uveitis, uveitis due to other causes than Behcets disease, or uveitis
of unknown etiology.

.Less severe (i.e. anterior or intermediate) uveitis associated with Behcets disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine if AIN457 is effective in reducing the rate of posterior segment uveitis exacerbations secondary to Behçet's disease, as assessed by visual acuity, anterior chamber cells and vitreous haze.   Wk 1-8; wk 12; wk 16; wk 22, and wk 24  
 
Secondary Outcome  
Outcome  TimePoints 
To determine if AIN457 can reduce the need for standard-of-care immunosuppressive medications (ISM) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçet's disease as measured by the ISM score.   24 weeks 
To assess the safety of targeted IL-17 inhibition with AIN457 in patients with posterior segment uveitis secondary to Behçet's disease receiving standard-of-care immunomodulatory therapy as measured by applanation tonometry and adverse events.  24 weeks  
To determine the effect of AIN457 on macular edema and visual acuity in patients with posterior segment uveitis secondary to Behçet's disease as determined by optical coherence tomography.   screening, baseline, and wk 24 (end of study) 
To establish the impact of AIN457 on quality of life of posterior segment uveitis patients secondary to Behçet's disease refractory to systemic immunomodulatory therapy as measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.   screening, and wk 24 (end of study) 
To observe the effect of AIN457 on the systemic non-ocular manifestations of Behçet's disease in patients with posterior segment uveitis requiring systemic immunosuppression as measured by the Bechet's disease current activity form.   baseline and wk 24 (end of study) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="117"
Sample Size from India="4" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 22/01/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  01/10/2009 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 No publication provided 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Target number of patients from India is 5. Planned FPFV is 15th December 2009. 
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