Status:
TERMINATED
Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
Lead Sponsor:
Sanofi
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658
Detailed Description
The study period per patient will include 62 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up performed in the form of a phone interview at 3, 6, 12, ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with Ulcerative Colitis (UC) who were previously randomized and have completed the 8-week treatment in ACT12688 study with an acceptable safety profile. Patients who for administrative reasons could not be enrolled in the LTS12593 study right after completion of the 8-week treatment in the ACT12688 study must be enrolled within 3 months from the end of the ACT12688 study
- Signed written informed consent for Study LTS12593
- Exclusion criteria:
- Patient with any adverse event leading to study drug (active or placebo) treatment discontinuation from ACT12688 study.
- Patient with any abnormalities or adverse events that per investigator judgment would adversely affect patient's participation in the long-term extension study.
- Use of any immunosuppressant (if patient is on immunosuppressant he or she must discontinue immunosuppressant before starting the LTS12593).
- If the patient started biological treatment for UC while waiting to be enrolled in the LTS12593, then he or she must stop the biological treatment and must have 8 weeks of wash out period before starting treatment with SAR339658 (only anti-tumor necrosis factors (TNFs) are allowed)
- Patients exposed to an anti-integrin or any investigational drug administered after the end of treatment in ACT12688
- Positive pregnancy test
- Breast feeding woman
- Women of childbearing potential not protected by highly effective contraceptive method of birth control and/or who are unwilling and unable to be tested for pregnancy.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01861249
Start Date
July 1 2013
End Date
April 1 2016
Last Update
July 13 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number 840059
Mission Hills, California, United States, 91345
2
Investigational Site Number 840008
Miramar, Florida, United States, 33025
3
Investigational Site Number 840048
Winter Park, Florida, United States, 32789
4
Investigational Site Number 840024
Mexico, Missouri, United States, 65265