Clinical Trials Directory

Trials / Completed

CompletedNCT01138657

Efficacy and Safety of Adalimumab in Patients With Active Uveitis

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - Including a Sub-study in Japanese Patients

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
239 (actual)
Sponsor
AbbVie (prior sponsor, Abbott) · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAdalimumabAdministered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by a 40 mg dose eow starting at Week 1.
DRUGPrednisoneAdministered orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all participants continuing in the study were to discontinue prednisone no later than Week 15.
DRUGPlaceboAdministered by subcutaneous injection

Timeline

Start date
2010-08-01
Primary completion
2014-07-01
Completion
2014-08-01
First posted
2010-06-07
Last updated
2021-07-07
Results posted
2016-08-22

Source: ClinicalTrials.gov record NCT01138657. Inclusion in this directory is not an endorsement.

Efficacy and Safety of Adalimumab in Patients With Active Uveitis (NCT01138657) · Clinical Trials Directory