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

This study is currently recruiting participants.

Verified March 2013 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 14, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2012

Last Updated Date

March 14, 2013

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01580670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pediatric Crohn's Disease

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: TA-650

Intervention: Drug: TA-650

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.).

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Clinical Trial Information Desk

cti-inq-ml@ml.mt-pharma.co.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01580670

Other Study ID Numbers ^ICMJE

TA-650-20

Has Data Monitoring Committee

Responsible Party

Mitsubishi Tanabe Pharma Corporation

Study Sponsor ^ICMJE

Mitsubishi Tanabe Pharma Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Toshifumi Hibi, MD	Keio University School of Medicine
Study Director:	Kazuoki Kondo, MD	Mitsubihsi Tanabe Pharma Corporation

Information Provided By

Mitsubishi Tanabe Pharma Corporation

Verification Date

March 2013

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

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