Phase 3
Completed N=14
Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
Pediatric Crohn's Disease
Source: ClinicalTrials.gov NCT01580670 ↗
Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Jul 2019
Primary outcomePrimary: Percent of Patients Who Achieved PCDAI Response — 78.6; 100.0; 100.0; 92.9 percentage of participants
Summary
The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Who Achieved PCDAI Response |
78.6; 100.0; 100.0; 92.9; 100.0; 92.9 | — |
| SECONDARY PCDAI Score |
36.43; 15.71; 8.75; 6.43; 7.86; 5.36 | — |
| SECONDARY Change From Baseline of PCDAI Score |
-20.71; -27.68; -30.00; -28.57; -31.07; -27.32 | — |
| SECONDARY Percent of Patients Who Achieved PCDAI-Based Remission Rate. |
42.9; 78.6; 71.4; 85.7; 85.7; 71.4 | — |
| SECONDARY Serum TA-650 Concentration |
0.0; 91.48; 17.47; 13.47; 16.46; 4.54 | — |
| SECONDARY The Percent of the Patients Who Experienced an Adverse Event |
100 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have been diagnosed as Crohn's disease at least 3 months prior to screening.
- Have active Crohn's disease despite adequate conventional therapy.
Exclusion Criteria
- Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery.
- Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and anti-IL-6 agents, etc.).
Data sourced from ClinicalTrials.gov (NCT01580670). 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.