Skip to main content

Table 2 Exclusion Criteria

From: A phase II trial protocol of Tocilizumab in anti-TNF refractory patients with JIA-associated uveitis (the APTITUDE trial)

Exclusion Criteria
Uveitis without a diagnosis of JIA fulfilling International League if Associations for Rheumatology diagnostic criteria for JIA (all subgroups that have uveitis). Currently on Tocilizumab or has previously received Tocilizumab.
Previous registration into the APTITUDE trial. Participation in another clinical trial of investigational medicinal product within the last 4 weeks or 5 serum half-lives (whichever is longer) prior to registration.
More than 6 topical steroid eye drops per day per eye at time of registration (dose must be stable for 1 week prior to registration). For participants on Prednisone or Prednisone equivalent, change of dose within 4 weeks prior to registration.
Participants on prednisone or prednisone equivalent with a dose > 0.2 mg/kg per day. No intraocular injection of disease modification agents including steroids and anti-Vascular endothelial growth factor within 4 weeks prior to registration.
No intraocular surgery for previous 12 weeks prior to registration or expected/panned for duration of study. Lack of recovery from recent surgery or surgery within 6 weeks at the time of registration.
Intra-ocular pressure ≥ 25 mmHg at time of registration. Participants requiring systemic therapy with oral anti-glaucoma medication.
No disease modifying immunosuppressive drugs, other than MTX in the 4 weeks prior to registration History of active tuberculosis of less than 24 weeks treatment.
Latent tuberculosis not successfully treated for at least 4 weeks prior to registration (a test for latent tuberculosis infection must be performed within 12 weeks prior to registration). Auto-immune, rheumatic disease or overlap syndrome other than JIA.
Females who are pregnant, lactating, or intending to become pregnant during trial. Known human immunodeficiency virus infection or other condition characterized by a compromised immune system.
Any history of alcohol or drug abuse within 24 weeks prior to registration. Any active acute, sub-acute, chronic, or recurrent bacterial, viral, systemic fungal, infection or any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of registration or treatment with oral antibiotics within 2 weeks of registration.
History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein−Barr virus within 8 weeks prior to registration. Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis.
History of concurrent serious gastrointestinal disorders. Evidence of current serious uncontrolled concomitant cardiovascular (including hyperlipidaemia), nervous system, pulmonary (including obstructive pulmonary disease), renal and hepatic disease.
History of or current cancer or lymphoma. Persistently poorly controlled severe hypertension (>95th percentile for height / age).
Uncontrolled diabetes mellitus. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
No live attenuated vaccines (including seasonal nasal flu vaccine, varicella vaccine for shingles or chickenpox, measles, mumps and rubella (MMR) or MMR varicella, oral polio vaccine and vaccines for yellow fever, measles, mumps or rubella) 4 weeks prior to registration, throughout the duration of the trial and for 8 weeks following the last dose of study drug. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies.
Treatment with intravenous gamma globulin or plasmapheresis within 24 weeks of registration Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
Any significant medical or surgical condition that would risk the participant’s safety or their ability to complete the trial Any joint injections within 4 weeks prior to registration
Any psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial Demonstrations of clinically significant deviations from the following laboratory parameters:
Serum creatinine > 1.5 × the upper limit of normal (ULN) for age and sex
Aspartate Aminotransferase Test or ALT > 1.5 × the ULN for age and sex
Total bilirubin > 1.3 mg/dL (> 23 μmol/L)
Platelet count < 150 × 103/μL (<  150,000/mm3) (<  150 × 109/L)
Haemoglobin < 7.0 g/dL (<  4.3 mmol/L)
White blood cell (WBC) count < 4000/mm3 (<  4.0 × 109/L)
Neutrophil count < 2000/mm3 (<  2.0 × 109/L)