Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Pediatric Ulcerative Colitis

Treatments: Drug: TA-650

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585155

TA-650-21

Details and patient eligibility

About

The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also evaluated.

Enrollment: 21 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening.
• Have active ulcerative colitis despite adequate conventional therapy.

Exclusion criteria

• Patients who have severe pancolitis.
• Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment.
• Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

TA-650

Experimental group

Treatment:

Drug: TA-650