Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis



Status:Completed
Conditions:Cervical Cancer, Ocular
Therapuetic Areas:Oncology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/8/2015
Start Date:July 2010
End Date:April 2015
Contact:Andy Payne, PhD
Email:andy.payne@abbvie.com
Phone:847-938-7795

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A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Inactive Non-infectious Intermediate, Posterior, or Pan-Uveitis

A study comparing the safety and efficacy of Adalimumab vs. Placebo in subjects with
inactive uveitis.


Inclusion Criteria:

- Subject is diagnosed with non-infectious intermediate, posterior, or pan-uveitis.

- 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 of Uveitis Nomenclature (SUN) criteria.

- Subject with Vitreous Haze grade (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 TB. Only one TB test is required
to allow the subject in the study. Subjects with either negative PPD (< 5mm of
induration) or negative QuantiFERON®-TB Gold test (or IGRA equivalent) are eligible.
Subjects with a repeat indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent)
result are not eligible. Note, that only one TB screening test is allowed and
required. A repeat QuantiFERON®-TB Gold test (or IGRA equivalent) is not permitted
if the PPD skin test is positive. The TB screening tests are diagnostic tests. In
the event of a negative TB screening test, the results are to be interpreted in the
context of the patient's epidemiology, history, exam findings, etc. and it is the
responsibility of the investigator to determine if a patient has previous, active or
latent tuberculosis or not. Under no circumstances can a patient with a positive
PPD result or positive QuantiFERON®-TB Gold test (or IGRA equivalent) enter the
study.

Exclusion Criteria:

- Subject with isolated anterior uveitis.

- Subject with confirmed or suspected infectious uveitis, including but not limited to
infectious uveitis due to TB, cytomegalovirus (CMV), Lyme disease, toxoplasmosis,
Human T-Lymphotropic Virus Type 1 (HTLV-1) infection, Whipple's disease, herpes
zoster virus(HZV) and herpes simplex virus(HSV).

- Subject with serpiginous choroidopathy.

- Subject with corneal or lens opacity that precludes visualization of the fundus or
that likely requires cataract surgery during the duration of the trial.

- Subject with intraocular pressure of >/= 25 mmHg and on >/= 2 glaucoma medications or
evidence of glaucomatous optic nerve injury.

- Subject with best corrected visual acuity (BCVA) less than 20 letters (ETDRS [Early
Treatment Diabetic Retinopathy Study]) in at least one eye at the Baseline visit.

- Subject with intermediate uveitis or panuveitis that has signs of intermediate
uveitis (e.g. presence or history of snowbanking or snowballs) and symptoms and/or
Magnetic Resonance Imaging (MRI) findings suggestive of a demyelinating disease such
as multiple sclerosis. All subjects with intermediate uveitis or panuveitis that have
signs of intermediate uveitis (e.g. presence or history of snowbanking or snowballs)
must have a brain MRI within 90 days prior to the Baseline visit.

- Subject has previous exposure to anti-TNF therapy or any biologic therapy (except
intravitreal anti- Vascular endothelial growth factor (VEGF) therapy) with a
potential therapeutic impact on non-infectious uveitis.

- Subject on concomitant immunosuppressive therapy other than methotrexate,
cyclosporine, mycophenolate mofetil or an equivalent drug to mycophenolate mofetil
(e.g., mycophenolic acid), azathioprine or tacrolimus within 28 days of Baseline or
has discontinued an immunosuppressive therapy including methotrexate, cyclosporine,
mycophenolate mofetil or an equivalent drug to mycophenolate mofetil (e.g.,
mycophenolic acid), azathioprine or tacrolimus within 28 days of Baseline.

- If entering the study on one concomitant immunosuppressive therapy, dose has not been
stable for at least 28 days prior to the Baseline visit or is not within the
following allowable doses at the Baseline visit:

- Methotrexate (MTX)
- Cyclosporine
- Mycophenolate mofetil mofetil (e.g. mycophenolic acid) at an equivalent dose approved by the Medical
Monitor

- Azathioprine
- Tacrolimus (oral formulation)
- Subject has Retisert® (glucocorticosteroids implant) within 3 years prior to the
Baseline visit or has had complications related to the device. Subject has had
Retisert® (glucocorticosteroid implant) removed within 90 days prior to the Baseline
visit or has had complications related to removal of the device.

- Subject has received intraocular or periocular corticosteroids within 90 days prior
to the Baseline visit.

- Subject with proliferative or severe non-proliferative diabetic retinopathy or
clinically significant macular edema due to diabetic retinopathy.

- Subject with neovascular/wet age-related macular degeneration.

- Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction,
epiretinal membranes, etc.) with the potential for macular structural damage
independent of the inflammatory process.

- Subject with cystoid macular edema unless the retinal changes are persistent,
residual and stable as defined by the Standardization of Uveitis Nomenclature (SUN)
criteria (persistent is > 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.
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