Evaluation of Health Costs and Resource Utilization

The purpose of this study is to evaluate the utilization of health resources in a testing
based strategy versus an empiric dose escalation strategy to manage Crohn's disease and
Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.

Inclusion Criteria:

- Males 18 years of age or older who are not receiving azathioprine or 6
mercaptopurine.

- Non-pregnant, non-lactating females, 18 years of age or older.

- Females of child bearing potential must have a negative serum pregnancy test prior to
randomization, and must use a hormonal (oral, implantable or injectable) or barrier
method of birth control throughout the study. [defined as a minimum of one year since
the last menstrual period]).

- Documented diagnosis of CD or UC.

- Active disease symptoms at visit 1 defined by: a. CD subjects: HBS ~ 6 UC subjects:
PMCS ~ 4.

- Current infliximab therapy (naive to adalimumab) or current adalimumab therapy (naive
to infliximab ).

- A minimum of 13 weeks of infliximab or adalimumab treatment prior to visit 1 at the
following dose:

- Stable dose of azathioprine, 6 mercaptopurine, methotrexate, and/or
5-aminosalicylates in the 4 weeks prior to visit 1.

Exclusion Criteria:

- Contraindication to the use of either infliximab or adalimumab.

- Current infliximab treatment but not naive to adalimumab or

- Current adalimumab treatment but not naive to infliximab.

- Infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w.

- Adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and
then 40 mg q2w.

- Received any investigational drug within 30 days prior to visit 1.

- Serious underlying disease other than CD or UC which in the opinion of the
investigator may interfere with the subject's ability to participate fully in the
study.

- History of alcohol or drug abuse which in the opinion of the investigator may
interfere with the subject's ability to comply with the study procedures.

- Stools positive for clostridium difficile.

- Pregnant or lactating women.

- Change in dose of azathioprine, 6 mercaptopurine, methotrexate, and/or
5-aminosalicylates in the 4 weeks prior to visit 1.

- Males 22 years of age or less who are receiving azathioprine or 6 mercaptopurine.