Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

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:
NCT01585155
First received: April 24, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pediatric Ulcerative Colitis
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 Ulcerative Colitis.

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 remission as defined by CAI score ≦4 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CAI score at Weeks 0, 2, 6, 8, 10, 14, 18, 22, 26, and 30 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ] [ Designated as safety issue: No ]
  • partial Mayo score at Weeks 0, 2, 6, 8, 10, 14, 18, 22, 26, and 30 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ] [ Designated as safety issue: No ]
  • Pediatric ulcerative colitis activity index (PUCAI) score at Weeks 0, 2, 6, 8, 10, 14, 18, 22, 26, and 30 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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 22.

  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 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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585155

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: NCT01585155     History of Changes
Other Study ID Numbers: TA-650-21
Study First Received: April 24, 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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014