Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

NCT ID: NCT01580670

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Pediatric Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TA-650

Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30.

Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg.

1. PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10

2. PCDAI score on the evaluation day exceeds 30

Group Type: EXPERIMENTAL

TA-650

Intervention Type: DRUG

TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

Interventions

TA-650

TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

Intervention Type: DRUG

Other Intervention Names

Infliximab

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.).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toshifumi Hibi, MD

Role: STUDY_DIRECTOR

Kitasato University Kitasato Institute Hospital

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Mitsubihsi Tanabe Pharma Corporation

Locations

Investigational site

Chūbu, , Japan

Investigational site

Hokkaido, , Japan

Investigational site

Hokuriku, , Japan

Investigational site

Kanto, , Japan

Investigational site

Kinki, , Japan

Investigational site

Kyusyu, , Japan

Investigational site

Tōhoku, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 30114224 (View on PubMed)

Other Identifiers

TA-650-20

Identifier Type: -

Identifier Source: org_study_id