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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01585155
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pediatric Ulcerative Colitis Drug: TA-650 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585155


Locations
Japan
Investigational site
Chubu, Japan
Investigational site
Hokkaido, Japan
Investigational site
Hokuriku, Japan
Investigational site
Kanto, Japan
Investigational site
Kinki, Japan
Investigational site
Kyusyu, Japan
Investigational site
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

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01585155     History of Changes
Other Study ID Numbers: TA-650-21
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Infliximab
REMICADE
TA-650

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