Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis

Stopped early · Phase 1/Phase 2

Conditions studied: Juvenile Idiopathic Arthritis Associated Uveitis

In brief

The investigators are doing this research study to see if tocilizumab (Actemra) is safe and effective when used for severe or refractory non-infectious uveitis. Uveitis is an inflammation of the eye that is caused by the body's immune system reacting against the eye tissues.

Key facts

Study ID

NCT01603355

Run by

Eric B. Suhler

People needed

3

Starts

2013-11-01

Expected to finish

2016-02-01

Last updated by the study team

2019-01-14

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with Juvenile Idiopathic Arthritis
• Subjects with vision-threatening autoimmune uveitis.
• Failure to respond to methotrexate or at least one other systemic immunosuppressive or intolerance to such medications due to side effects. Failure to respond includes presence of one plus or greater anterior chamber cell in both eyes; need for topical corticosteroid four times or more in either eye; ocular hypertension or glaucoma attributable to the topical corticosteroid.
• Subjects with bilateral disease.
• If subjects are on oral corticosteroids, the dosage must be stable for 2 weeks prior to baseline and not exceed 10 mg per day or 2mg/kg/day (whichever is less) of prednisone or its equivalent. Subjects must be willing to agree to not alter the dosage of oral steroids during the first 16 weeks of the trial.
• Must have a chest radiograph within 3 months prior to enrollment with no evidence of malignancy, infection or fibrosis.
• Parent or guardian must understand and voluntarily sign an informed consent form.
• Pediatric subjects of either gender 2-17 years at time of consent.

You may not qualify if…

• Inability of parent or guardian to provide voluntary consent
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 12 months following randomization.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Pregnant or breastfeeding
• Current liver disease, as determined by the Principal Investigator on the basis of history or serum studies
• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies including tocilizumab.
• Evidence of significant uncontrolled concomitant diseases such as nervous system, renal, hepatic (patients with prior history of ALT elevation will not be excluded), endocrine, or gastrointestinal (GI) disorders, which in the Investigator's opinion, would preclude patient participation.
• Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
• Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 2 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 2 years prior to screening visit are allowed if successful treatment was completed at least 2 years prior to randomization and is documented and available for verification.
• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
• Latent Mycobacterium tuberculosis infection as indicated by a positive Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
• If QuantiFERON® test is performed instead of the PPD test, only those with a negative QuantiFERON® test are allowed in the study.
• History of incompletely treated Mycobacterium tuberculosis infection as indicated by
• Subject's medical records documenting incomplete treatment for Mycobacterium tuberculosis
• Subject's self-reported history of incomplete treatment for Mycobacterium tuberculosis
• History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years) or recurrent viral, fungal, mycobacterial, or other infections (including but not limited to atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
• Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
• Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
• History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
• Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
• History of Human Immunodeficiency Virus (HIV) infection
• Antibodies to Hepatitis C at screening
• Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
• Have multiple sclerosis or other central demyelinating disorder.

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.