BACKGROUND
Crohn's disease (CD) is a chronic inflammatory disorder that primarily affects the gastrointestinal tract. Pediatric cases commonly begin in late middle childhood and adolescence. When active, the disease can be debilitating, embarrassing, and socially isolating. Typical experiences include pain, frequent and bloody diarrhea, fatigue and emotional distress. Children with CD experience negative side effects on their physical well-being, emotions and mood. Compared with adult counterparts, pediatric CD patients present with more extensive distribution of psychosocial difficulties, problems with academic performance and altered pubertal development and growth. Approximately 8% of children require intestinal resection during the year following diagnosis.
The Anti-TNF Combination trial provides a unique opportunity to evaluate PROMIS measures in pediatric CD. Children under 18 years old with pediatric Crohn's disease (both genders, all race and ethnicities) with moderate to severe disease activity who are initiating their first anti-TNF agent will constitute the study population.
The trial will occur in the offices of pediatric gastroenterologists who participate in ImproveCareNow, a learning health system. ImproveCareNow was formed in 2007 to transform health, care and costs for all children and adolescents with Crohn's disease and ulcerative colitis by building sustainable collaborative chronic care network that enables patients, families, clinicians and researchers to work together to accelerate innovation, discovery and application of new knowledge.
