Woman and Man
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Extract
- Evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through <18 years old and determine if it is similar to that observed in adults with moderately to severely active CD. - Assess the safety and immunogenicity of ustekinumab in this population. - Assess the efficacy of ustekinumab in the treatment of moderately to severely active CD, including assessment of improvement in the endoscopic appearance of the mucosa. If feasible, the relationship between PK and the short-term efficacy of ustekinumab will be assessed in this population.
Inclusion criteria
- Moderately-to-Severely Active Crohn’s Disease