Patient selection: pediatric patient with perianal Crohn's disease, on infliximab therapy
Clinical measures:
(1) number of fistulas at baseline
(2) current number of fistulas
(3) status of any ulcerations present at baseline
Complete response - both of the following:
(1) (one or more fistulas at baseline) AND (no current fistulas)
(2) complete healing of any ulcerations
Partial response - both of the following:
(1) reduction of draining fistulas from baseline by >= 50%
(2) partial healing of any ulceration
Therapeutic failure - one or both of the following
(1) not complete or partial response
(2) discontinuation of therapy before one full year of treatment (adverse effects, lack of efficacy, other)
