Adalimumab vs Conventional ImmunoSuppression for Corticosteroid-sparing for Uveitis (ADVISE) Trial

Phase 1

• Conditions: veitic macular oedema; MedDRA version: 20.0Level: LLTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 100000004853; MedDRA version: 20.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 100000004853; MedDRA version: 20.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-002366-12-GB
• Lead Sponsor: Johns Hopkins University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-18
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 222

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

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.

Study & Design

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