Phase 3 N=261 Randomized Quadruple-blind Treatment

Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis

Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT01124838 ↗

Enrolled (actual)

261

Serious AEs

6.9%

Results posted

Jun 2016

Primary outcome: Primary: Time to Treatment Failure on or After Week 2 — 8.3; NA; 5.6; NA months — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Adalimumab (Drug); Prednisone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Treatment Failure on or After Week 2	8.3; NA; 5.6; NA	0.004 sig
SECONDARY Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit	0.57; 0.41; 0.61; 0.46; 0.53; 0.40	0.218
SECONDARY Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit	0.33; 0.16; 0.35; 0.18; 0.27; 0.18	0.070
SECONDARY Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit	0.06; 0.01; 0.07; 0.02; 0.02; -0.01	0.096
SECONDARY Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2	NA; NA; NA; NA	0.491
SECONDARY Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.	6.4; 4.5; 6.3; 5.2; 7.7; 5.4	0.451
SECONDARY Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit	1.24; 3.36; 1.00; 2.79	0.160
SECONDARY Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit	0.76; 2.64; 0.60; 2.96	0.401
SECONDARY Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit	3.98; 3.88; 3.73; 2.89	0.967
SECONDARY Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit	2.87; 3.42; 2.60; 2.15	0.830

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.

Eligibility Criteria

Inclusion Criteria

Subject is diagnosed with non-infectious intermediate, posterior, or panuveitis.
Subject that for ≥ 28 days prior to the Baseline visit has inactive disease and is taking ≥ 10 mg of oral prednisone to maintain this inactive state and fulfillment of all 3 of the following criteria based on the Investigator's clinical judgment at the Screening and Baseline visits for both eyes:
Subject without active, inflammatory chorioretinal and/or inflammatory retinal vascular lesions.
Subject with anterior chamber cell grade ≤ 0.5+ according to Standardization of Uveitis Nomenclature (SUN) criteria.
Subject with vitreous haze grade ≤ 0.5+ according to National Eye Institute (NEI)/SUN criteria.
Subject is on oral prednisone 10 to 35 mg/day (or oral corticosteroid equivalent) at Baseline and the dose has not been increased in the past 28 days or decreased in the past 14 days.
Subject must have a documented history of experiencing at least one disease flare within 18 months of the Screening visit. This flare has to occur during or up to a maximum of 28 days after tapering off the oral corticosteroid therapy.
Subjects who do not have previous, active or latent tuberculosis (TB). Only one TB test is required to allow the subject in the study. Subjects with either negative purified protein derivative (PPD) ( 3 months duration).
Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.
Subject has received intravitreal anti-VEGF therapy:
within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab);
or within 60 days of the Baseline visit for anti-VEGF Trap (Aflibercept).
Subject on systemic carbonic anhydrase inhibitor within 1 week prior to Screening visit.
Subject with a history of scleritis.
Subject on cyclophosphamide within 30 days prior to the Baseline visit.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01124838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.