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

April 24, 2012
March 20, 2014
February 2012
March 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01585155 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pediatric Ulcerative Colitis
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.
Experimental: TA-650
Intervention: Drug: TA-650
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2015
March 2015   (final data collection date for primary outcome measure)

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.).
Both
6 Years to 17 Years
No
Contact: Clinical Trial Information Desk cti-inq-ml@ml.mt-pharma.co.jp
Japan
 
NCT01585155
TA-650-21
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Director: Toshifumi Hibi, MD Keio University School of Medicine
Study Director: Kazuoki Kondo, MD Mitsubihsi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP