Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

The following eligibility criteria applied to participants enrolled following Amendment 3 to the study protocol.

Inclusion Criteria

• Male and female participants >= 18 years of age
• Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline
• Diagnosis of active ulcerative colitis confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection
• Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):
• Stable oral corticosteroid dose (prednisone dose of >= 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisone of = 1.5 mg/kg/day or 6 MP >= 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Participant was to be on a stable dose for at least 28 days prior to Baseline.

Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.

• Had to be able to self-administer or has caregiver who can reliably administer subcutaneous injections.
• Had to be able and willing to give written informed consent and to comply with the requirements of this study protocol.
• Female had to be either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or of childbearing potential and practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control included the following:
• Condoms, sponge, foams, jellies, diaphragm or intrauterine device
• Oral, parenteral or intravaginal contraceptives for 90 days prior to study drug administration
• A vasectomized partner
• The results of the serum pregnancy test performed at the Screening Visit and urine pregnancy test performed at the Baseline Visit had to be negative.
• Judged to be in generally good health as determined by the principal investigator

Exclusion Criteria

• History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or is planning bowel surgery.
• Received infliximab or any other anti-TNF agent or any biological therapy in the past.
• Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
• Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
• Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
• Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of the Screening Period.
• Current diagnosis of fulminant colitis and/or toxic megacolon.
• Participants with disease limited to the rectum (ulcerative proctitis).
• Current diagnosis of indeterminate colitis.
• Current diagnosis and/or history of Crohn's disease.
• Currently receiving total parenteral nutrition.
• Discontinued use of azathioprine or 6-MP within 28 days of Baseline.
• Discontinued use of corticosteroid within 14 days of Baseline.
• Participants using aminosalicylates for less than 90 days prior to Baseline, not on a stable dose for at least 28 days prior to Baseline, or discontinued use within 28 days of Baseline.
• Participants with positive Clostridium difficile stool assay.
• Infections requiring treatment with intrav