A study comparing the safety and efficacy of Adalimumab vs. Placebo in subjects with Inactive uveitis.
- Conditions
- Inactive non-infectious intermediate-, posterior-, or pan-uveitis.MedDRA version: 17.0Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2009-016008-22-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1. Subject is = 18 years of age.
2. Subject is diagnosed with non-infectious intermediate-, posterior- or pan-uveitis.
3. 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 Investigators' clinical judgment at the Screening and Baseline visits for both eyes:
? Subject without active, inflammatory chorioretinal and/or inflammatory retinal vascular lesion.
? Subject with Anterior Chamber Cell grade = 0.5+ according to SUN criteria.
? Subject with Vitreous Haze grade = 0.5+ according to NEI/SUN criteria.
4. 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.
5. 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.
6. Subjects who do not have previous, active or latent TB.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
• Subject with isolated anterior uveitis.
• 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 > or = 25 mmHg and on > or = 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 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:
o Methotrexate (MTX) = 25 mg per week
o Cyclosporine = 4 mg/kg per day
o Mycophenolate mofetil = 2 grams per day or an equivalent drug to mycophenolate mofetil (e.g. mycophenolic acid) at an equivalent dose approved by the Medical Monitor
o Azathioprine = 175 mg per day
o Tacrolimus (oral formulation) = 8 mg per day
• Subject has received Retisert® (glucocorticosteroid 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 the 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Time to treatment failure. Please refer to section 5.3.3.1 of the study protocol for further information.;Main Objective: The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week subcutaneously starting at Week 1 compared with placebo in subjects with inactive non-infectious intermediate-, posterior-, or pan-uveitis.;Secondary Objective: Not Applicable;Timepoint(s) of evaluation of this end point: All visits after Baseline.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change in Anterior Chamber (AC) cell grade in each eye from Baseline to the Final/Early Termination visit<br>• Change in Vitreous Haze grade (NEI/SUN criteria) in each eye from Baseline to the Final/Early Termination visit<br>• Change in logMAR BCVA in each eye from Baseline to the Final/Early Termination visit<br>• Time to OCT evidence of macular edema in at least one eye or after week 2<br>• Percent change in central retinal thickness in each eye from Baseline to the Final/Early Termination visit<br>• Change in NEI Visual Functioning Questionnaire score (VFQ-25) composite score from Baseline to the Final/Early Termination visit;Timepoint(s) of evaluation of this end point: All visits after Baseline.