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 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
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.
