Phase 3
Completed N=21
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Pediatric Ulcerative Colitis
Source: ClinicalTrials.gov NCT01585155 ↗
Enrolled (actual)
21
Serious AEs
14.3%
Results posted
Oct 2019
Primary outcomePrimary: Percent of Patients Who Achieved CAI Remission — 60.0; 80.0; 80.0; 77.8 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Who Achieved CAI Remission |
60.0; 80.0; 80.0; 77.8; 87.5; 87.5 | — |
| SECONDARY CAI Score |
9.7; 4.0; 3.5; 3.2; 2.7; 2.7 | — |
| SECONDARY Partial Mayo Score |
5.6; 2.6; 2.2; 1.7; 2.2; 1.9 | — |
| SECONDARY Pediatric Ulcerative Colitis Activity Index (PUCAI) Score |
47.1; 20.3; 17.3; 12.5; 14.7; 12.2 | — |
Eligibility Criteria
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.).
Data sourced from ClinicalTrials.gov (NCT01585155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.