38 Week Extension Study to CAIN457C2303 (SHIELD)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Uveitis

Treatments: Drug: Placebo AIN457; Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093846

2009-013901-33

CAIN457C2303E1

Details and patient eligibility

About

A 38-week extension to 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

Enrollment: 59 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 3 patient groups, including a placebo group

AIN457 300 mg every 2 weeks

Experimental group

Treatment:

Drug: AIN457

Drug: AIN457

AIN457 300 mg monthly

Experimental group

Treatment:

Drug: AIN457

Drug: AIN457

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo AIN457