| CTRI Number |
CTRI/2009/091/000898 [Registered on: 04/06/2010] |
| Last Modified On: |
18/09/2014 |
| 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 Patients With Quiescent Non-infectious Uveitis (ENDURE) |
|
Scientific Title of Study
|
A 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAIN457C2301 |
Protocol Number |
| NCT01032915 |
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 |
KMurugananthan |
| Designation |
Head Clinical Development |
| Affiliation |
Novartis Healthcare Pvt Ltd. |
| Address |
Novartis Healthcare Private Limited, Medical Department Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli.
Novartis Healthcare Private Limited, Medical Department Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958545 |
| Fax |
02224954112 |
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
KMurugananthan |
| Designation |
Head Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Medical Department Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli.
Novartis Healthcare Private Limited, Medical Department Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli.
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958545 |
| Fax |
02224954112 |
| Email |
murugananthan.k@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajvardhan Azad |
AIIMS |
Room No: 486, 4th floor office block,Dr. R P Centre for Ophthalmic sciences, Ansari Nagar-110029
|
011-26593187
011-26588919
rajvardhanazad@hotmail.com |
| Dr. B. Manohar Babu |
Aravind Eye Hospital |
Avinashi Road,-641 014
Coimbatore
TAMIL NADU |
422 4360400
dr.mb@cbe.aravind.org |
| Dr. S. R Rathinam |
Aravind Eye Hospital |
Uveitis Services,,1, Anna Nagar,-625020
Madurai
TAMIL NADU |
0452 4356100
rathinam@aravind.org |
| Dr. Someishila Murthy |
L.V.Prasad Eye Institute |
Kallam Anji Reddy Campus,L.V.Prasad Marg, Banjara Hills-500 034
Hyderabad
ANDHRA PRADESH |
09885283827
smurthy@lvpei.org |
| Dr. Kavitha Avadhani |
Narayana Nethralaya |
,-
Bangalore
KARNATAKA |
|
| Dr. Amod Gupta |
Post Graduate Institute of Medical Education & Research |
Room No. 116, Ground floor,Advanced Eye Centre-160 012
Chandigarh
CHANDIGARH |
0172 2756111
eyepgi@sify.com |
| Dr. Himadri Datta |
Regional Institute of Ophthalmology |
Medical College, 88 College Street, ,-700 073
Kolkata
WEST BENGAL |
033?40071886
himadri.datta@gmail.com |
| Dr. Jyotirmay Biswas |
Shankara Nethralaya |
Vision research Foundation, ,18 College Road, -600006
Chennai
TAMIL NADU |
09841428151
drjb@snmail.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethical Committtee, regional Institute of Ophthalmology Medical College & Hospital |
Approved |
| Institute Ethics Committee, All India Institute of Medical Sciences New Delhi |
Approved |
| Institute Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
| Institutional Review Board, Aravind Eye Care System |
Approved |
| Institutional Review Board/Ethical Committee, Aravind Eye Hospital |
Approved |
| L.V. Prasad Institute Review Board |
Approved |
| Narayana Nethralaya Ethics Committee |
Approved |
| Vision Research Foundation |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
quiescent, chronic non-infectious, intermediate uveitis, posterior uveitis
or panuveitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biological: AIN457 |
150mg s.c at baseline and Week 2 |
| Intervention |
Biological: AIN457 |
300mg s.c at baseline and Week 2 |
| Intervention |
Biological: AIN457 |
300mg s.c weekly for 3 weeks |
| Comparator Agent |
Placebo Comparator |
Placebo s.c weekly for 3 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by less than 1+ anterior chamber cell grade and less than 1+ vitreous haze in both eyes for at least 6 weeks prior to screening.
Requirement for either of the following immunosuppressive therapies at any time within the past 3 months for the treatment or prevention of uveitis which must not have been increased within the 6 weeks prior to screening:
Prednisone or equivalent greater than or equal to 10 mg daily.
greater than or equal to 1 periocular injection or greater than or equal to 1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening.)
Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate as monotherapy or in combination with or without steroids. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study.)
Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator.
|
|
| ExclusionCriteria |
| Details |
Ocular concomitant conditions/disease
* Patients with a primary diagnosis of Behcet's disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (i.e. Punctate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR.)
* Patients with active, non-infectious intermediate, posterior or panuveitis in one or both eyes (greater than or equal to 1+ anterior chamber cells and /or greater than or equal to 1+ vitreous haze.)
* Patients receiving or that may require corticosteroids (prednisone or equivalent) greater than or equal to 1 mg/kg/day to maintain quiescence of their intraocular inflammation.
Ocular treatments
* Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening.
* Treatment with fluocinolone acetonide implant (Retisert®) in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months.
* Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.
Systemic conditions or treatments
* Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial.
* Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening.
* Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening. No treatment with live or live-attenuated vaccines will be allowed during the course of the clinical trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| * Recurrence of active intermediate, posterior, or panuveitis defined by either: greater than or equal to 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of greater than or equal to 10 ETDRS letters |
after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| * Change in immunosuppressive medication score from baseline to 24 weeks |
Baseline to 24 weeks |
| * Mean change in best corrected visual acuity from baseline |
Baseline to 24 weeks |
| * Mean time to recurrence of active intermediate, posterior, or panuveitis from baseline |
Baseline to 24 weeks |
| * Change from baseline in Quality of Life/Patient reported outcome assessments |
Baseline to 24 weeks |
| * Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 24 weeks |
Baseline to 24 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="232"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
06/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/02/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
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 48.
Planned FPFV is 8th June 2010. |