Determining Predictors of Safe Discontinuation of Anti-TNF Treatment in JIA
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      Polyarticular juvenile idiopathic arthritis (Poly JIA) is a form of juvenile arthritis, which
      is a chronic disease affecting approximately 250,000 people younger than 16 years of age.
      Poly JIA can be treated with anti-tumor necrosis factor (anti-TNF), a type of medication that
      is often effective but also has some toxic side effects and is expensive. Among those with
      poly JIA who are effectively treated with anti-TNF, some can remain healthy off the
      medication, but some begin to feel the effects of their disease again once the medication is
      stopped. This study will attempt to find whether certain tests or signs can predict which
      people with poly JIA can safely stop their anti-TNF medications.
    

Detailed description: 
      Juvenile arthritis is a chronic disease affecting approximately 250,000 people younger than
      16 years of age in the United States. Its symptoms include swelling, pain, and damage in the
      joints. Juvenile arthritis can take four different forms, including poly JIA. Poly JIA
      affects five or more joints, generally the smaller ones in wrists and fingers, causing
      stiffness, joint damage, and sometimes eye inflammation in the children and adolescents who
      suffer from it. Approximately 30% of people with juvenile arthritis have Poly JIA.

      Treatment for juvenile arthritis involves drugs with escalating strength, depending on what
      each individual responds to best. The first treatment option is non-steroidal
      anti-inflammatory drugs (NSAIDs), such as Motrin IB and Aleve. The second treatment option is
      methotrexate (MTX). About 30% to 50% of poly JIA patients are effectively treated with MTX.
      Only if the patient does not respond to MTX is an anti-TNF drug used. Anti-TNF drugs often
      result in profound disease improvement, but unfortunately, they can have toxic side effects
      and are expensive.

      For people whose poly JIA is inactive or minimally active on MTX or anti-TNF drugs, 50% to
      80% experience a worsening of symptoms once they stop taking the medications. Most of these
      flare-ups occur within 8 months of stopping treatment. Currently, there is no way to predict
      which people with poly JIA can safely stop anti-TNF medications. This study will evaluate two
      different factors-levels of certain calcium binding proteins and production of TNF-for their
      use in predicting whether people with poly JIA are likely to experience a disease flare-up
      once they stop anti-TNF treatment. The study will also look for genetic markers that can
      serve as predictors of safe discontinuation of anti-TNF treatment.

      Participation in this study will last up to 14 months and involve up to nine study visits.
      Visits will be conducted at study entry and after 3, 6, 7, 8, 9, 10, 12, and 14 months. The
      first three study visits will involve tests to determine baseline health indicators and to
      ensure inactive disease. If, after 6 months, participants continue to have inactive disease,
      they will be taken off their anti-TNF medications. For the remainder of the study, visits
      will be used to monitor disease activity. If participants experience any clinically defined
      disease flare-ups, they will immediately stop participating in the study and begin additional
      treatment as prescribed by their health care providers. At all study visits, participants
      will undergo a general physical examination, a joint examination, questionnaires about how
      the disease affects their lives, and blood collection for research samples.
    

Intervention name(s): Withdrawal of anti-TNF therapy
Intervention type(s): Other
Intervention description(s): Anti-TNF therapy will be discontinued at the third visit in children who demonstrate persistent inactive disease for at least 6 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poly JIA; TNF; Remission