Clinical trial NCT01494857 (phase 3, status: unknown status)
Conditions: ulcerative colitis
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: adalimumab
SMILES: O
Eligibility criteria:

        Inclusion Criteria:

          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.

        Exclusion Criteria:

          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
             Baseline.

          4. Received intravenous corticosteroids within 14 days prior to Screening or during the
             Screening Period.

          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 Period.

          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
             of Baseline.

         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
             Baseline.

         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.