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

This study has been completed.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: April 3, 2012
Last updated: April 9, 2015
Last verified: April 2015
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: 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 ]

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 ]
  • 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 ]

Enrollment: 14
Study Start Date: March 2012
Study Completion Date: March 2015
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 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01580670

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
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 Identifier: NCT01580670     History of Changes
Other Study ID Numbers: TA-650-20
Study First Received: April 3, 2012
Last Updated: April 9, 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
pediatric Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on May 22, 2017