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
- Conditions
- eye inflammationuveitis10021877
- Registration Number
- NL-OMON39258
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Subject is >= 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 at a dose of >= 10 mg/day to <= 60 mg/day (or oral corticosteroid equivalent):;* 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 at a dose of >= 10 mg/day to <= 60 mg/day (or oral corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from Screening to Baseline visit.;Subjects who do not have previous, active or latent TB.
1. Subject with isolated anterior uveitis.;2. Subject with prior inadequate response to high-dose oral;corticosteroids.;3. 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).;4. Subject with presumed ocular histoplasmosis syndrome (POHS).;5. Subject with ocular masquerade syndromes, such as ocular lymphoma.;6. Subject with serpiginous choroidopathy.;7. Subject has a contraindication to pupil dilation with mydriatic eyedrops.;8. Subject with corneal or lens opacity that precludes visualization of the fundus or;that likely requires cataract surgery during the duration of the trial.;9. Subject with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications;or evidence of glaucomatous optic nerve injury.;10. 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.;11. 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.;12. Subject has previous exposure to anti-TNF therapy or any biologic therapy (except;intravitreal anti-vascular endothelial growth factor [VEGF] therapy [See Exclusion;Criterion No. 43]) with a potential therapeutic impact on non infectious uveitis.;13. Subject on more than 1 immunosuppressive therapy (not including corticosteroids);at Baseline.;14. 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 at Baseline.;15. 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) <= 25 mg per week;* Cyclosporine <= 4 mg/kg per day;* 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.;* Azathioprine <= 175 mg per day;*Tacrolimus (oral formulation) <= 8 mg per day;16. Subject with prior or current use of chlorambucil.;17. 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.;18. Subject has received intraocular or periocular corticosteroids within 30 days prior;to the Baseline visit.;19. Subject with history of prior ocular surgery within 90 days prior to the Baseline visit with the exception of refractive laser surgery or retinal laser photocoagulation or YAG (neodymium-doped yttrium aluminium garnet) posterior capsulotomy. These three exceptio
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the Time to Treatment Failure. Treatment<br /><br>Failure is defined in the table on page 30 of the protocol for Week 6 and all<br /><br>other visits thereafter.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Change in Vitreous Haze grade (NEI/SUN criteria) in each eye from Week 6 to<br /><br>the Final/Early Termination visit<br /><br>2. Change in logMAR BCVA in each eye from Week 6 to the Final/Early Termination<br /><br>Visit<br /><br>3. Time to OCT evidence of macular edema in at least one eye on or after Week 6<br /><br>4. Change in central retinal thickness in each eye from Week 6 to the<br /><br>Final/Early Termination visit<br /><br>5. Change in NEI Visual Functioning Questionnaire (VFQ-25) score from Week 6 to<br /><br>the Final/Early Termination visit</p><br>