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Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uveitis

Intervention: adalimumab (Drug); prednisone (Drug); prednisone (Drug); adalimumab placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Andy Payne, Study Director, Affiliation: AbbVie

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to Treatment Failure

Secondary outcome:

Change in Anterior Chamber (AC) cell grade in each eye.

Change in Vitreous Haze grade (NEI/SUN criteria) in each eye.

Change in logarithm of the minimum angle of resolution (logMAR) BCVA in each eye.

Time to optical coherence tomography (OCT) evidence of macular edema in at least one eye.

Percent change in central retinal thickness in each eye.

Change in NEI Visual Functioning Questionnaire (VFQ-25) composite score.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Site Reference ID/Investigator# 71297, Buenos Aires C1015ABO, Argentina

Site Reference ID/Investigator# 71315, Buenos Aires B1629ODT, Argentina

Site Reference ID/Investigator# 75257, Rosario S2000DFA, Argentina

Site Reference ID/Investigator# 25793, East Melbourne 3002, Australia

Site Reference ID/Investigator# 25792, Nedlands 6009, Australia

Site Reference ID/Investigator# 25796, Salzburg 5020, Austria

Site Reference ID/Investigator# 25795, Vienna 1030, Austria

Site Reference ID/Investigator# 25799, Ghent 9000, Belgium

Site Reference ID/Investigator# 25800, Leuven 3000, Belgium

Site Reference ID/Investigator# 72754, Rio de Janeiro 21941-913, Brazil

Site Reference ID/Investigator# 76454, Sao Paulo 04023-062, Brazil

Site Reference ID/Investigator# 26008, Calgary T2H 0C8, Canada

Site Reference ID/Investigator# 26002, Montreal H1T 2M4, Canada

Site Reference ID/Investigator# 47399, Ottawa K1H 8L6, Canada

Site Reference ID/Investigator# 77943, Vancouver V5Z 3N9, Canada

Site Reference ID/Investigator# 82674, Vancouver V6Z 1Y6, Canada

Site Reference ID/Investigator# 25802, Prague 2 128 00, Czech Republic

Site Reference ID/Investigator# 25804, Aarhus 8000, Denmark

Site Reference ID/Investigator# 25812, Nantes Cedex 1 44093, France

Site Reference ID/Investigator# 25806, Paris Cedex 14 75679, France

Site Reference ID/Investigator# 25815, Freiburg 79106, Germany

Site Reference ID/Investigator# 25814, Heidelberg 69120, Germany

Site Reference ID/Investigator# 76754, Kiel 24105, Germany

Site Reference ID/Investigator# 25813, Muenster 48145, Germany

Site Reference ID/Investigator# 74640, Thessaloniki 57001, Greece

Site Reference ID/Investigator# 25819, Petach Tikva 49100, Israel

Site Reference ID/Investigator# 25822, Tel Aviv 64239, Israel

Site Reference ID/Investigator# 78354, Bologna 40138, Italy

Site Reference ID/Investigator# 25825, Milan 20132, Italy

Site Reference ID/Investigator# 47963, Negrar (Verona) 37024, Italy

Site Reference ID/Investigator# 71854, Reggio Emilia 42100, Italy

Site Reference ID/Investigator# 25824, Rome 00161, Italy

Site Reference ID/Investigator# 26337, Fukuoka-shi, Japan

Site Reference ID/Investigator# 26334, Mitaka, Japan

Site Reference ID/Investigator# 88036, Nagakute, Japan

Site Reference ID/Investigator# 26330, Sapporo-shi, Japan

Site Reference ID/Investigator# 29604, Sendai-shi, Japan

Site Reference ID/Investigator# 26336, Suita-shi, Japan

Site Reference ID/Investigator# 26331, Tokyo, Japan

Site Reference ID/Investigator# 26332, Tokyo, Japan

Site Reference ID/Investigator# 26333, Tokyo, Japan

Site Reference ID/Investigator# 88037, Tokyo, Japan

Site Reference ID/Investigator# 88038, Ube-shi, Japan

Site Reference ID/Investigator# 26335, Yokohama-shi, Japan

Site Reference ID/Investigator# 71554, Mexico DF 04030, Mexico

Site Reference ID/Investigator# 71294, Tijuana 22320, Mexico

Site Reference ID/Investigator# 25840, Rotterdam 3011 BH, Netherlands

Site Reference ID/Investigator# 74814, Gdansk-Chelm 80-809, Poland

Site Reference ID/Investigator# 74817, Wroclaw 50-556, Poland

Site Reference ID/Investigator# 25829, Coimbra 3000-075, Portugal

Site Reference ID/Investigator# 25830, Barcelona 08028, Spain

Site Reference ID/Investigator# 75614, Bern CH-3012, Switzerland

Site Reference ID/Investigator# 75234, Lausanne 1004, Switzerland

Site Reference ID/Investigator# 25842, Aberdeen AB25 2ZD, United Kingdom

Site Reference ID/Investigator# 25841, Bristol BS1 2LX, United Kingdom

Site Reference ID/Investigator# 73355, Liverpool L7 8XP, United Kingdom

Site Reference ID/Investigator# 25843, London EC1V 2PD, United Kingdom

Site Reference ID/Investigator# 25426, Phoenix, Arizona 85014, United States

Site Reference ID/Investigator# 49743, Beverly Hills, California 90211, United States

Site Reference ID/Investigator# 58302, Tamarac, Florida 33321, United States

Site Reference ID/Investigator# 26182, Tampa, Florida 33603, United States

Site Reference ID/Investigator# 25622, Chicago, Illinois 60612, United States

Site Reference ID/Investigator# 37132, Ellsworth, Maine 04605, United States

Site Reference ID/Investigator# 24613, Baltimore, Maryland 21287, United States

Site Reference ID/Investigator# 75436, Baltimore, Maryland 21287, United States

Site Reference ID/Investigator# 65692, Boston, Massachusetts 02114, United States

Site Reference ID/Investigator# 24606, Cambridge, Massachusetts 02142, United States

Site Reference ID/Investigator# 24605, Palisades Park, New Jersey 07650, United States

Site Reference ID/Investigator# 108338, New York, New York 10021, United States

Site Reference ID/Investigator# 24608, New York, New York 10003, United States

Site Reference ID/Investigator# 24607, Belmont, North Carolina 28012, United States

Site Reference ID/Investigator# 26603, Durham, North Carolina 27705, United States

Site Reference ID/Investigator# 63244, Winston-Salem, North Carolina 27157, United States

Site Reference ID/Investigator# 24622, Oklahoma City, Oklahoma 73104, United States

Site Reference ID/Investigator# 24623, Portland, Oregon 97239, United States

Site Reference ID/Investigator# 24609, Philadelphia, Pennsylvania 19104, United States

Site Reference ID/Investigator# 27403, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 24624, Houston, Texas 77025, United States

Site Reference ID/Investigator# 25429, Houston, Texas 77030, United States

Site Reference ID/Investigator# 24616, San Antonio, Texas 78240, United States

Site Reference ID/Investigator# 25434, Salt Lake City, Utah 84132, United States

Site Reference ID/Investigator# 24617, Norfolk, Virginia 23502, United States

Site Reference ID/Investigator# 97496, Morgantown, West Virginia 26506, United States

Additional Information

This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.

Starting date: July 2010
Last updated: June 26, 2015

Page last updated: August 23, 2015

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