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 (InspirAda)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01550965

M13-045

2011-002411-29 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This was a single arm, open-label, multicenter study. The primary objectives were to study the effect of adalimumab on QOL (as measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), the utilization of health care resources, and the costs of care for subjects with UC who were treated with adalimumab in the usual clinical practice setting. The secondary objectives were to further assess the effect of adalimumab on disease activity and to collect additional safety data in subjects with UC.

Enrollment: 463 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

463 participants in 1 patient group

Participants Receiving Adalimumab

Experimental group

Description:

Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.

Treatment:

Biological: Adalimumab