Clinical trial NCT01585155: Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Official title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Ulcerative Colitis
Keywords: Infliximab
REMICADE
TA-650
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.).

Primary outcomes:
measure: Percent of Patients Who Achieved CAI Remission
timeFrame: 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 outcomes:
measure: CAI Score
timeFrame: 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
measure: Partial Mayo Score
timeFrame: 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
measure: Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
timeFrame: 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
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Investigational site
city: Hokkaido
country: Japan
facility: Investigational site
city: Hokuriku
country: Japan
facility: Investigational site
city: Kanto
country: Japan
facility: Investigational site
city: Kinki
country: Japan
facility: Investigational site
city: Kyusyu
country: Japan
facility: Investigational site
city: Tohoku
country: Japan
facility: Investigational site
Study officials:
affiliation: Kitasato University Kitasato Institute Hospital
name: Toshifumi Hibi, MD
role: STUDY_DIRECTOR
affiliation: Mitsubihsi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: 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 Oct 13;19(1):351. doi: 10.1186/s12887-019-1739-5.