A Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting (InspirAda)

• Change (6 months after versus the past 6 months) in costs of Ulcerative Colitis (UC)-related medical care excluding adalimumab costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
  Costs will be determined from the health care utilization information
• Change (6 months after versus the past 6 months) in total all-cause direct health care costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
  Costs will be determined from the health care utilization information
• Change (6 months after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
  Costs will be determined from the health care utilization information
• Reduction (6 months after versus the past 6 months) in direct UC-related and all-cause hospitalization [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
  Hospitalization will be determined from the health care utilization information and from Serious Adverse Event reporting
• Change in patient satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]) at Week 26 from Week 0 (Baseline) [ Time Frame: Week 0, Week 2, Week 8, up to Week 26 ] [ Designated as safety issue: No ]
  TSQM is a questionnaire to be completed by the subjects to determine their satisfaction of the medications for ulcerative colitis including the study drug

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

Assess the effect of adalimumab on quality of life as measured by the Short Quality of Life Inflammatory Bowel Disease (SIBDQ), the utilization of health care resources and the costs of care for the ulcerative colitis subjects treated with adalimumab.

Inclusion Criteria:

1. Subjects must be male or female between the ages of 18 and 75 years old at the time of the Screening Visit.
2. Subjects must have a diagnosis of Ulcerative Colitis (UC) greater than 90 days prior to Week 0 (Baseline) and failed conventional treatment.
3. Subjects' diagnosis of active UC must be confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy.
4. Subjects must have active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at Week 0 (Baseline).

5. Subjects must be on a concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):

   • Stable oral corticosteroid dose (prednisone ≥ 20 mg/day or equivalent) for at least 14 days prior to Baseline. or
   • Stable oral corticosteroid dose (prednisone < 20 mg/day) for at least 21 days prior to Baseline. and/or
   • At least a consecutive 12 weeks (84 days) course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline. Concurrent therapy will not be required for subjects who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.

Exclusion Criteria:

1. Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
2. Subjects received previous treatment with an anti-tumor necrosis factor (TNF) agent (including infliximab or adalimumab) or previous participation in an adalimumab clinical study.
3. Subjects received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Week 0 (Baseline).
4. Subjects received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period.
5. Subjects with a current diagnosis of fulminant colitis and/or toxic megacolon.