A Study to Compare ADalimumab vs. Conventional ImmunoSupprEssion for Uveitis

Overview

About this study

The primary purpose of this study is to compare the relative effectiveness of adalimumab vs. conventional immunosuppression at controlling ocular inflammation while permitting tapering of prednisone to < 7.5 mg/day.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 13 years or older.
  • 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:
      • Initiation of prednisone at dose greater than 7.5 mg/day;
      • Increasing prednisone dose to greater than 7.5 mg/day;
      • 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:

  • Patient level exclusion criteria.
  • Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-γ release assay [IGRA] test, such as Quantiferon-gold).
  • Untreated active hepatitis B or C infection.
  • Behçet disease.
  • Multiple sclerosis.
  • For patients with intermediate uveitis, abnormal magnetic resonance imaging (MRI) of the brain consistent with demyelinating disease.
  • Use of anti-TNF monoclonal antibody therapy within past 60 days.
  • History of adalimumab intolerance or ineffectiveness.
  • 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®, YutiqTM, 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, lactation, or for women of child-bearing potential unwillingness to use appropriate birth control for the duration of the trial.
  • Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wendy Smith, M.D.

Contact us for the latest status

Contact information:

Hamad Gul

(507)284-5833

Gul.Hamad@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20478566

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