A 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
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Quality of Life; Costs of Ulcerative Colitis; Health Care Utilization

Summary:

      This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in
      participants with ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants had to be a male or female between the ages of 18 and 75 years old at the
             time of the Screening Visit.

          2. Participants who had a diagnosis of ulcerative colitis (UC) greater than 90 days prior
             to baseline (week 0) and failed conventional treatment.

          3. Participants diagnosis of active UC was confirmed by a colonoscopy with biopsy or
             flexible sigmoidoscopy with biopsy.

          4. Participants who had active UC with a Physicians Global Assessment (PGA) score of 2 or
             3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at baseline (week
             0).

          5. Concurrent therapy was required for participants who were previously treated with
             corticosteroids or immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP))
             and, in the judgment of the investigator, had failed to respond to or could not
             tolerate their treatment. Participants had to 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 AZA or 6-MP prior to
                  baseline.

        Exclusion Criteria:

          1. Participants who had a history of subtotal colectomy with ileorectostomy or colectomy
             with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.

          2. Participants received previous treatment with adalimumab or previous participation in
             an adalimumab clinical study.

          3. Participants who had previously used infliximab or any anti- tumor necrosis factor
             (TNF) agent within 56 days of baseline (week 0).

          4. Participants who had previously used infliximab or any anti-TNF agent and had not
             clinically responded at any time ("primary non-responder") unless they experienced a
             treatment limiting reaction.

          5. Participants who had received cyclosporine, tacrolimus, or mycophenolate mofetil
             within 30 days of baseline (week 0).

          6. Participants who had received intravenous (IV) corticosteroids within 14 days of
             Screening or during the screening period.

          7. Participants who had a current diagnosis of fulminant colitis and/or toxic megacolon.