Trial intelligence / Profile preview

Pilot Study of Leflunomide in Uveitis

NCT00001863Phase 2

Key facts

Status: Completed
Start: Mar 1999
Countries: 1
Sponsor: National Eye Institute
Modality: Small Molecules

Drugs: leflunomide
Conditions: uveitis

Overview

Phase 2, randomised, double-blind trial in uveitis comparing Leflunomide with Placebo (2 arms). Primary endpoints: Frequency of Adverse Events at 24 weeks, Composite Treatment Failure at 12 months and 2 more. Started Mar 1999; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Leflunomide
Leflunomide + Prednisone
Placebo
Placebo + Prednisone

Who it enrols

Patients 16 years or older with active intermediate, posterior, or panuveitis who are intolerant or resistant to corticosteroids.

Endpoints

Primary

Frequency of Adverse Events24 weeks
Composite Treatment Failure12 months
Weight Loss Distributions24 weeks
Change in Liver Function Tests24 weeks

Secondary

Change in Vitreous Haze24 weeks
Presence or Absence of Cystoid Macular Edema24 weeks

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