Extension Study of MT-1303 in Subjects With Crohn's Disease

September 1, 2017 updated by: Mitsubishi Tanabe Pharma Corporation

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • City Name, Czechia
        • Investigational Site
  • France
      • City Name, France
        • Investigational Site
  • Germany
      • City Nmae, Germany
        • Investigational Site
  • Hungary
      • City Nmae, Hungary
        • Investigational Site
  • Israel
      • City Name, Israel
        • Investigational Site
  • Italy
      • City Name, Italy
        • Investigational Site
  • Japan
      • City Nmae, Japan
        • Investigational Site
  • Netherlands
      • City Name, Netherlands
        • Investigational Site
  • Poland
      • City Name, Poland
        • Investigational Site
  • Slovakia
      • City Name, Slovakia
        • Investigational Site
  • Ukraine
      • City Name, Ukraine
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.

Exclusion Criteria:

  • Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-1303
Drug: MT-1303

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects with Adverse Events
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-E14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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