Clinical trial NCT01580670: Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
Official title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Crohn's Disease
Keywords: Infliximab
REMICADE
TA-650
pediatric Crohn's disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 14
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 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.

Detailed description: This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

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.).

Primary outcomes:
measure: Percent of Patients Who Achieved PCDAI Response
timeFrame: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54
Secondary outcomes:
measure: PCDAI Score
timeFrame: Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54
measure: Change From Baseline of PCDAI Score
timeFrame: Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54
measure: Percent of Patients Who Achieved PCDAI-Based Remission Rate.
timeFrame: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54
measure: Serum TA-650 Concentration
timeFrame: After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration.
measure: The Percent of the Patients Who Experienced an Adverse Event
timeFrame: Until the last time point during the period from administration of the study drug to Week 54
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, Motoya S, Kinjo F, Maemoto A, Matsumoto T, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with Crohn's disease: A Phase 3, open-label, uncontrolled, multicenter trial in Japan. PLoS One. 2018 Aug 16;13(8):e0201956. doi: 10.1371/journal.pone.0201956. eCollection 2018.