Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis
1. Male or female ≥ 18 years of age.
2. Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
3. Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy
with biopsy during the Screening Period, with exclusion of infection.
4. 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 < 20 mg/day) for at least 40 days prior to Baseline, and/or
- At least a consecutive 90 day course of azathioprine or 6-mercaptopurine (6 MP)
prior to Baseline, with a dose of azathioprine >= 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.
5. 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.
6. Has to be able to self-administer subcutaneous injections or has caregiver who can
reliably administer subcutaneous injections.
7. Has to be able and willing to give written informed consent and to comply with the
requirements of this study protocol.
1. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
Koch pouch, or ileostomy for UC or is planning bowel surgery.
2. Received previous treatment with adalimumab or previous participation in an
adalimumab clinical study.
3. Received cyclosporine, tacrolimus, or mycophenolate mofetil, within 30 days prior to
4. Received intravenous corticosteroids within 14 days prior to Screening or during the
5. Received therapeutic enema or suppository, other than required for endoscopy, within
14 days prior to the Screening endoscopy and during the remainder of Screening
6. Current diagnosis of fulminant colitis and/or toxic megacolon.
7. Subject with disease limited to the rectum (ulcerative proctitis).
8. Current diagnosis of indeterminate colitis.
9. Current diagnosis and/or history of Crohn's disease.
10. Currently receiving total parenteral nutrition (TPN).
11. Subject using aminosalicylates for less than 90 days prior to Baseline or not on a
stable dose for at least 28 days prior to Baseline or discontinued use within 28 days
12. Subject with positive Clostridium difficile (C. difficile) stool assay.
13. Subject who has previously used infliximab or any anti-TNF agent within 56 days of
14. Subject who has previously used infliximab or any anti-TNF agent and has not
clinically responded at any time ("primary non-responder") unless subject experienced
a treatment limiting reaction.