NCT01124838

Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Inactive Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - Including a Sub-study in Japanese Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	Adalimumab	Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by 40 mg eow starting at Week 1.
DRUG	Prednisone	Administered orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all subjects continuing in the study were to discontinue prednisone no later than Week 19.
DRUG	Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2010-05-17
• Last updated: 2021-07-07
• Results posted: 2016-06-21