Uveitic macular oedema MedDRA version: 20.0 Level: LLT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10033687 Term: Panuveitis System Organ Class: 100000004853 MedDRA version: 20.1 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Adalimumab
Product Name: Adalimumab
Pharmaceutical Form: Injection
INN or Proposed INN: Adalimumab
Other descriptive name: Humira
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Johns Hopkins University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 13 years or older 2. Active or recently active (= 60 days) non-infectious, intermediate, posterior, or panuveitis 3. Prednisone indication meets one of the following: a. Active uveitis requiring one of the following i. Initiation of prednisone at dose greater than 7.5 mg/day ii. Increasing prednisone dose to greater than 7.5 mg/day iii. Currently receiving dose greater than 7.5 mg/day b. Inactive uveitis on current dose greater 7.5 mg/day 4. Initiation or addition of an immunosuppressive drug (i.e., a conventional immunosuppressive drug or adalimumab) is indicated 5. If currently receiving a conventional immunosuppressive drug, the drug and dose have been stable for at least 30 days 6. Patient able and willing to self-administer subcutaneous injections or have a qualified person available to administer subcutaneous injections 7. If posterior segment disease is present, ability to assess activity in at least one eye with uveitis 8. Visual acuity of light perception or better in at least one eye with uveitis Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-? release assay [IGRA] test, such as Quantiferon-gold) 2. Untreated active hepatitis B or C infection 3. Behçet disease 4. Multiple sclerosis 5. For patients with intermediate uveitis, abnormal magnetic resonance imaging (MRI) of the brain consistent with demyelinating disease 6. Use of anti-TNF monoclonal antibody therapy within past 60 days 7. History of adalimumab intolerance or ineffectiveness 8. Current treatment with an alkylating agent 9. Current treatment with more than one immunosuppressive drug, not including oral corticosteroids 10. Shorter-acting regional corticosteroids administered within the past 30 days in any eye(s) with uveitis 11. Long-acting ocular corticosteroid implants, i.e., fluocinolone acetonide implant (e.g., Retisert®, YutiqTM, Iluvien®) placed within past 3 years unless uveitis is active in all eye(s) with an implant 12. Systemic disease that is sufficiently active such that it dictates therapy with systemic corticosteroids or immunosuppressive agents at the time of enrollment 13. Immunodeficiency disease for which immunosuppressive therapy would be contraindicated according to best medical judgment 14. Pregnancy, lactation, or for women of child-bearing potential unwillingness to use appropriate birth control for the duration of the trial 15. Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Adalimumab will be superior to conventional immunosuppression for corticosteroid-sparing by one year of follow-up as determined by the proportion achieving inactive uveitis at prednisone 28 days apart within one year of follow-up; 2. Adalimumab will be superior to conventional immunosuppression for maintaining control of inflammation after discontinuation of prednisone for 2 visits >28 days apart by one year of follow-up. ;Primary end point(s): The primary outcome of the ADVISE Trial will be a corticosteroid-sparing treatment success, defined as inactive uveitis, on prednisone 28 days apart within the first 6 months after randomization.;Timepoint(s) of evaluation of this end point: 6 months after randomization.;Main Objective: The ADVISE Trial is a randomized, parallel-treatment, comparative effectiveness trial, comparing adalimumab to conventional immunosuppression for the treatment of non-infectious, intermediate, posterior, and panuveitides. Based on the preliminary data we assume that adalimumab will be superior to conventional immunosuppression for successful corticosteroid-sparing with no clinically important increase in uveitis symptoms namely inactive uveitis and prednisone 28 days apart by 6 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary corticosteroid sparing outcomes 1. The ability to achieve inactive uveitis and prednisone 28 days apart within one year of randomization. 2. The ability to achieve inactive uveitis and completely discontinue prednisone for 2 consecutive visits >28 days apart within 6 months and one year of randomization. 3. Prednisone exposure (e.g., cumulative prednisone dose and/or mean prednisone dose) in the 2 groups over 1 year with emphasis on the 6-month (primary outcome) and 1-year (end of follow-up) visits. | — |
Countries
Australia, Canada, United Kingdom, United States
Contacts
Public ContactManjo Doug
Vision and Eye Research Unit - Anglia Ruskin University
Outcome results
None listed