At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 239 enrolled
Drug / intervention
Adalimumab +2 morebiological
Likely dose
Adalimumab 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Adalimumab, Prednisone, and 1 other intervention for Uveitis. Completed, enrolled 239 participants.
Detailed Summary
A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUveitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartAug 2010
Primary CompletionJul 2014
Study CompletionAug 2014
TodayJul 2026
First PostedJun 7, 2010
Enrollment StartAug 1, 2010
Primary CompletionJul 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.1 years ago
Interventions
Adalimumabbiological
Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by a 40 mg dose eow starting at Week 1.
Prednisonedrug
Administered 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.
Placebodrug
Administered by subcutaneous injection