Status:
COMPLETED
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
Lead Sponsor:
JHSPH Center for Clinical Trials
Conditions:
Uveitis
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression....
Detailed Description
Abstract from protocol: The uveitides are a collection of diseases characterized by intraocular inflammation. Collectively, they are the 5th leading cause of blindness in the US, and the estimated cos...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age 13 years or older
- Weight 30 kg (66 lbs) or greater
- Active or recently active (≤ 60 days) non-infectious intermediate, posterior, or panuveitis
- Prednisone indication meets one of the following:
- 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
- Inactive uveitis on current dose greater 7.5 mg/day
- Initiation or addition of an immunosuppressive drug (i.e., a conventional immunosuppressive drug or adalimumab) is indicated
- If currently receiving a conventional immunosuppressive drug, the drug and dose have been stable for at least 30 days
- Patient able and willing to self-administer subcutaneous injections or have a qualified person available to administer subcutaneous injections
- If posterior segment disease is present, ability to assess activity in at least one eye with uveitis
- Visual acuity of light perception or better in at least one eye with uveitis
- Exclusion criteria
- Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-γ release assay \[Interferon-gamma release assay (IGRA) test, such as Quantiferon-gold)
- Untreated active hepatitis B or C infection
- Any of the following baseline lab values
- White blood count \<3500 cells per microliter
- Platelets \<100,000 per microliter
- Hematocrit \<30%
- aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.5 times (X) upper limit normal value
- Serum creatinine \>1.1 times (X) upper limit normal value
- Behçet disease
- Multiple sclerosis or other demyelinating disease
- For patients with anterior/intermediate or intermediate uveitis without systemic disease, abnormal magnetic resonance imaging (MRI) of the brain consistent with demyelinating disease
- Severe uncontrolled infection
- Receipt of a live vaccine within past 30 days
- Moderate to severe heart failure (NYHA class III/IV)
- Active malignancy
- Use of anti-TNF monoclonal antibody therapy within past 60 days
- History of adalimumab intolerance or ineffectiveness
- Hypersensitivity to any of the study treatments or their excipients
- Current treatment with an alkylating agent
- Current treatment with more than one immunosuppressive drug, not including oral corticosteroids
- Shorter-acting regional corticosteroids administered within the past 30 days in any eye(s) with uveitis
- Long-acting ocular corticosteroid implants, i.e., fluocinolone acetonide implant (e.g., Retisert®, Yutiq™, Iluvien®) placed within past 3 years unless uveitis is active in all eye(s) with an implant
- Systemic disease that is sufficiently active such that it dictates therapy with systemic corticosteroids or immunosuppressive agents at the time of enrollment
- Immunodeficiency disease for which immunosuppressive therapy would be contraindicated according to best medical judgment
- Pregnancy or lactation
- For persons of child-bearing potential or impregnating potential, unwillingness to use appropriate birth control (abstinence, combination barrier and spermicide, hormonal, or intrauterine device) for the next 18 months or plans to become a biological parent within the next 18 months.
- \* In the United Kingdom (UK), use of combination barrier and spermicide alone does not meet birth control requirements.
- † UK female study participants must use highly effective methods of contraception.
- UK male study participants must use condoms for at least 6 months after the end of study treatment and their female partners of child-bearing potential are recommended to use highly effective contraception for the same duration. In addition, male participants should not donate semen during therapy or for 6 months following discontinuation of study treatment.
- Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.
Exclusion
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT03828019
Start Date
September 16 2019
End Date
September 9 2024
Last Update
May 16 2025
Active Locations (26)
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1
Jules Stein Eye Institute, UCLA
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
4
Emory University
Atlanta, Georgia, United States, 30322