Safety and Efficacy of AIN457 in Behçet's Patients With Posterior or Panuveitis (SHIELD)

Phase 3

Completed

• Registration Number: CTRI/2009/091/000874
• Lead Sponsor: ovartis Health care Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 117

Inclusion Criteria

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

Exclusion Criteria

. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified