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:
Mitsubishi Tanabe Pharma Corporation
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
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Purpose
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: | 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 Crohn's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (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.
|
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580670
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: | NCT01580670 History of Changes |
| Other Study ID Numbers: | TA-650-20 |
| Study First Received: | April 3, 2012 |
| Last Updated: | March 14, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
|
Infliximab REMICADE TA-650 pediatric Crohn's disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013