Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis | Completed
Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
Visual II
Trial Source

Health Conditions
  • Uveitis
Completed
Recruitment Status
NCT01124838
Primary Trial ID Number
Summary
A study comparing the safety and efficacy of Adalimumab vs. Placebo in subjects with inactive uveitis.
Primary Outcome Measures
  • Time to Treatment Failure; Evaluated at all visits after Baseline
Secondary Outcome Measures
  • Change in Anterior Chamber (AC) cell grade in each eye.; Evaluate from Baseline to the Final/Early Termination visit.; Change in Vitreous Haze grade (NEI/SUN criteria) in each eye.; Evaluate from Baseline to the Final/Early Termination visit.; Change in logarithm of the minimum angle of resolution (logMAR) BCVA in each eye.; Evaluate from Baseline to the Final/Early Termination visit.; Time to optical coherence tomography (OCT) evidence of macular edema in at least one eye.; Evaluate at all visits after Baseline.; Percent change in central retinal thickness in each eye.; Evaluate from Baseline to the Final/Early Termination visit.; Change in NEI Visual Functioning Questionnaire (VFQ-25) composite score.; Evaluate from Baseline to the Final/Early Termination visit.
Research Question
  • A study comparing the safety and efficacy of Adalimumab vs. Placebo in subjects with inactive uveitis.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Czech Republic; Denmark; France; Germany; Greece; Israel; Italy; Japan; Mexico; Netherlands; Poland; Portugal; Spain; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion 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.
Interventions
Drug; adalimumab; Subjects will be randomized into one of two arms. Arm 1 will receive adalimumab 80 mg subcutaneous (SC) loading dose at Baseline followed by 40 mg doses eow starting at Week 1. Arm 2 will receive matching placebo. Randomization will be a 1:1 ratio double masked fashion to the treatment groups using baseline immunosuppressant usage as the stratification factor.; [adalimumab]; Drug; prednisone; Based on the dose of corticosteroids at study entry, a pre-defined taper schedule will be followed that mandates discontinuation of corticosteroid therapy no later than Week 19. Subjects who enter this study on another corticosteroid will be converted to an equivalent dose of prednisone at Baseline.; [adalimumab]; Drug; prednisone; Based on the dose of corticosteroids at study entry, a pre-defined taper schedule will be followed that mandates discontinuation of corticosteroid therapy no later than Week 19. Subjects who enter this study on another corticosteroid will be converted to an equivalent dose of prednisone at Baseline.; [adalimumab placebo]; Drug; adalimumab placebo; Placebo 80 mg subcutaneous (SC) loading dose at the Baseline study visit followed a week later by 40 mg placebo injections eow starting at Week 1.; [adalimumab placebo]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Visual II
Scientific 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
Secondary Trial Identifying Number
2009-016008-22
Website
http://rxabbvie.com
Study Funded By
AbbVie (prior sponsor, Abbott)
Funder Type
Sorry, this information is not available
Study Sponsored By
AbbVie (prior sponsor, Abbott)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

14 May 2010

Last Updated

26 Jun 2015

Date Record Refreshed on UKCTG

31 Jul 2015