Efficacy and Safety of Adalimumab in Subjects With Active Uveitis | Completed
Efficacy and Safety of Adalimumab i... | Completed
Efficacy and Safety of Adalimumab in Subjects With Active Uveitis
VISUAL l
Trial Source

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Medical Conditions
  • Uveitis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01138657
Primary Trial ID Number

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Summary
A study comparing the safety and efficacy of Adalimumab vs. Placebo in subjects with active uveitis.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : adalimumab, Drug : prednisone, Drug : adalimumab placebo, Drug : prednisone

Study Arm Groups : adalimumab, adalimumab, adalimumab placebo, adalimumab placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Time to Treatment Failure; Evaluated at all visits at or after the Week 6 Visit
Secondary Outcome Measures
    Change in Anterior Chamber (AC) cell grade in each eye.; Best state achieved prior to Week 6 to Final Visit/Early Termination Visit; Change in Vitreous Haze grade in each eye (National Eye Institute/ Standardization of Uveitis Nomenclature [NEI/SUN] criteria in each eye.; Best state achieved prior to Week 6 to Final Visit/Early Termination Visit; Change in logarithm of the minimum angle of resolution (logMAR) BCVA in each eye; Best state acheived prior to Week 6 to Final Visit/Early Termination Visit; Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least one eye; Evaluated at all visits at or after the Week 6 Visit; Change in central retinal thickness in each eye; Best state achieved prior to Week 6 to Final Visit/Early Terminationation; Change in NEI Visual Functioning Questionnaire (VFQ-25) composite score.; Best state achieved prior to Week 6 to Final Visit/Early Termination Visit.
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Subject is at least 18 years of age.

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

    - Subject must have active disease at the Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone >/= 10 mg/day to
    - Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion

    - >/= 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)

    - >/= 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)

    - Subject is on oral prednisone >/= 10 mg/day to
    - Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).

    - 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 (< 5 mm 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 prior inadequate response to high-dose oral corticosteroids

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

    - If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within the last 28 days prior to Baseline visit or is not within the following allowable doses at the Baseline visit:

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

    - Subject has received intraocular or periocular corticosteroids within 30 days prior to 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 severe vitreous haze that precludes visualization of the fundus at the Baseline visit.

    - Subject has received Ozurdex® (dexamethasone implant) within 6 months 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 has received intravitreal methotrexate within 90 days prior to the Baseline visit

    - Subject on systemic carbonic anhydrase inhibitor within 1 week prior to Screening visit.

    - Subject with macular edema as the only sign of uveitis.

    - Subject with a history of scleritis.

    - Subject with intolerance to high-dose oral corticosteroids (equivalent of oral prednisone 1 mg/kg/day or 60 to 80 mg/day).

    - Subject on cyclophosphamide within 30 days prior to the Baseline visit.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Liverpool
Merseyside
L7 8XP
London
EC1V 2PD
Aberdeen
AB25 2ZD
Bristol Eye Hospital
Bristol
BS1 2LX
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate-, Posterior-, or Pan-uveitis
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
M10-877
Sponsor(s)
AbbVie (prior sponsor, Abbott)
Key Dates

Recruitment Start Date

Aug 2010

Recruitment End Date

Jul 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

14 May 2010

Date updated in source

13 Jul 2015