Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)

Sponsor
Heidelberg University
Study ID
NCT00348153
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

TNF alpha Inhibitors have been very effective in treating rheumatologic diseases as well as uveitis. Adalimumab is the first member of a new class of TNF antibody compounds developed to contain exclusively human sequences. We want to test the efficacy and safety of the TNF alpha Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive therapy.

Key Dates

Start date
Aug 31, 2006
Status verified
Nov 2012
Primary completion
Sep 30, 2012
Completion
Mar 31, 2013

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab + corticosteroids + immunosuppressive treatments
    Adalimumab 40 mg eow, stable immunosuppression, corticosteroids in 1 mg/kg/Bodyweight (max. 80 mg) and taper
  • Active Comparator: immunosuppressive treatment + corticosteroids
    corticosteroids upped to 1mg/kg/Bodyweight and taper, stable immunosuppressive treatment

Primary Outcome Measure

Improvement of visual acuity (3 lines EDTRS) [ Time Frame: at week 0, 2, 6, 12 and 24 ]

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