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

This study is currently recruiting participants.
Verified March 2014 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01580670
First received: April 3, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) and other evaluation indicators in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks 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.


Condition Intervention Phase
Pediatric Crohn's Disease
Drug: TA-650
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change from baseline of percent of participants with clinical response as defined by a decrease of PCDAI score of at least 15 points with a total score of no more than 30 points [ Time Frame: Baseline(Week 0) and Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PCDAI at Weeks 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 [ Time Frame: Baseline(Week 0) and Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 ] [ Designated as safety issue: No ]
  • Change from baseline in percent of participants with clinical remission as defined by PCDAI score ≦ 10 [ Time Frame: Baseline(Week 0) and Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-650 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 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580670

Contacts
Contact: Clinical Trial Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Investigational site Recruiting
Chubu, Japan
Investigational site Recruiting
Hokkaido, Japan
Investigational site Recruiting
Hokuriku, Japan
Investigational site Recruiting
Kanto, Japan
Investigational site Recruiting
Kinki, Japan
Investigational site Recruiting
Kyusyu, Japan
Investigational site Recruiting
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Toshifumi Hibi, MD Keio University School of Medicine
Study Director: Kazuoki Kondo, MD Mitsubihsi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01580670     History of Changes
Other Study ID Numbers: TA-650-20
Study First Received: April 3, 2012
Last Updated: March 20, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Infliximab
REMICADE
TA-650
pediatric Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014