Basiliximab Maintenance in Ulcerative Colitis

An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population

Inclusion Criteria:

1. Previously met eligibility criteria in the previous basiliximab UC study
2. Must have a total Mayo score at entry consistent with clinical response or clinical remission.
3. Signed a current IRB/IEC-approved informed consent form
4. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
5. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.

Exclusion Criteria:

1. Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:

   • Heart rate > 90 beats/min at rest
   • Temperature > 37.8 degrees C
   • Hemoglobin < 10.5 g/dL

2. Subject is currently receiving a restricted/prohibited concomitant medication

3. Subject has undergone colectomy (total, or subtotal)

4. Subject is pregnant or breast-feeding

5. Prior noncompliance with previous study visit schedule and requirements