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

• Conditions: Active Non-infectious Intermediate-, Posterior-, or Pan-uveitis; MedDRA version: 14.1Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2009-016095-68-PT
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-14
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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.
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

Exclusion Criteria

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 ca

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects requiring high dose corticosteroids for active non-infectious intermediate-, posterior-, or pan-uveitis.;Secondary Objective: Not applicable;Primary end point(s): Time to treatment failure. Please refer to section 5.3.3.1 of the study protocol for further information. ;Timepoint(s) of evaluation of this end point: It will be evaluated at Week 6 and each visit thereafter.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in Anterior Chamber (AC) cell grade in each eye from Week 6 to the Final/Early Termination visit.<br>2. Change in Vitreous Haze grade (NEI/SUN criteria) in each eye from Week 6 to the Final/Early Termination visit.<br>3. Change in logMAR BCVA in each eye from Week 6 to the Final/Early Termination Visit<br>4. Time to OCT evidence of macular edema in at least one eye on or after Week 6<br>5. Percentage change in central retinal thickness in each eye from Baseline to the Final/Early Termination visit<br>6. Change in NEI Visual Functioning Questionnaire (VFQ-25) composite score from Week 6 to the Final/Early Termination visit;Timepoint(s) of evaluation of this end point: Please see details in E.5.2.