NCT02782663

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of an Active drug in Subjects With Crohn's Disease

Brief summary

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of an active drug.

Interventional

Interventional study

Status:
Active, not recruiting
Conditions:
Crohn's Disease (CD)
Enrollment:
107 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-327
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion Criteria:

- Participant must have completed Study M13-740 through Week 52.

- If female, participant must be postmenopausal, surgically sterile or on using a birth
control method.

Exclusion Criteria:

- For any reason participant is considered by the investigator to be an unsuitable
candidate

- Female participant with a positive pregnancy test at Baseline or who is considering
becoming pregnant during the study.

- Participant is not in compliance with prior and concomitant medication requirements
and procedures throughout Study M13-740.

All the cities where the clinical studies are located

Edmonton - T6G 2X8
Vancouver - V5Z 1M9
Vancouver - V6Z 2K5
Vaughan - L4L 4Y7
Montreal - H4A 3J1

Alberta

Edmonton

British Columbia

Vancouver

Ontario

Vaughan

Quebec

Montreal

More information about this study

clinicaltrials.gov