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

Pediatric Ulcerative Colitis Clinical Trial

Official title:

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585155
• Other study ID #: TA-650-21
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2019
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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-TNFa agents, anti-IL-6 agents, etc.).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Pediatric Ulcerative Colitis
• Ulcer

Intervention

Drug:
• TA-650
TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.

Locations

Country	Name	City	State
Japan	Investigational site	Chubu
Japan	Investigational site	Hokkaido
Japan	Investigational site	Hokuriku
Japan	Investigational site	Kanto
Japan	Investigational site	Kinki
Japan	Investigational site	Kyusyu
Japan	Investigational site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Tajiri H, Arai K, Kagimoto S, Kunisaki R, Hida N, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan. BMC Pediatr. 2019 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients Who Achieved CAI Remission	Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day.; CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.	Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Secondary	CAI Score	CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.	Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Secondary	Partial Mayo Score	Mayo score consists of four subscores (stool frequency, rectal bleeding, physician's global assessment and findings of endoscopy), each of which was assessed according to a four-level rating scale (0 to 3 points), and was determined from a total of the four subscores (0 to 12 points). In addition, the sum of the subscores (0 to 9 points) for stool frequency, rectal bleeding and physician's global assessment was used as a partial Mayo score. A higher score indicates greater disease activity.	Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Secondary	Pediatric Ulcerative Colitis Activity Index (PUCAI) Score	PUCAI score was determined as a total of the subscores for each of the six evaluation items (0 to 85), including abdominal pain, rectal bleeding, stool consistency of most stools, number of stools per 24 hours, nocturnal stools and activity level. A higher score indicates greater disease activity.	Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30