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

NCT01580670 | Completed Phase 3 Results

• 1 other identifier: TA-650-20
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 7

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.

Conditions

Pediatric Crohn's Disease

Keywords

Infliximab; REMICADE; TA-650; pediatric Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Who Achieved PCDAI Response

  Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

  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 (5)

• PCDAI Score

  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

• Change From Baseline of PCDAI Score

  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

• Percent of Patients Who Achieved PCDAI-Based Remission Rate.

  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

• Serum TA-650 Concentration

  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.

• The Percent of the Patients Who Experienced an Adverse Event

  Until the last time point during the period from administration of the study drug to Week 54

Study Arms (1)

TA-650

EXPERIMENTAL

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

Drug: TA-650

Interventions

TA-650 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.

Also known as: Infliximab

TA-650

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (7)

Investigational site

Chūbu, Japan

Location

Investigational site

Hokkaido, Japan

Location

Investigational site

Hokuriku, Japan

Location

Investigational site

Kanto, Japan

Location

Investigational site

Kinki, Japan

Location

Investigational site

Kyusyu, Japan

Location

Investigational site

Tōhoku, Japan

Location

Related Publications (1)

• 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.

  PMID: 30114224 RESULT

MeSH Terms

Conditions

Pediatric Crohn's disease

Interventions

Infliximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Toshifumi Hibi, MD

  Kitasato University Kitasato Institute Hospital

  STUDY DIRECTOR

• Kazuoki Kondo, MD

  Mitsubihsi Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 19, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 7, 2026
• Results First Posted: July 5, 2019

Record last verified: 2025-12

Locations

JP (7)