Clinical trial NCT01861249: Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
Official title: A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, 18 and 24 months from the last administration of the study medication.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with Adverse Events
timeFrame: Up to Week 68
Secondary outcomes:
measure: Percentage of participants with abnormal safety parameters (laboratory data and vital signs)
timeFrame: Up to Week 68
measure: Proportion of participants with Clinical Remission by Mayo Score
timeFrame: At Week 62
measure: Proportion of participants with Mucosal Healing
timeFrame: At Week 62
measure: Change from baseline in the partial Mayo Score
timeFrame: At Weeks 10, 22, 34, 46 and 58
measure: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: At Weeks 34 and 62
Other outcomes:
Locations:
city: Mission Hills
country: United States
facility: Investigational Site Number 840059
state: California
city: Miramar,
country: United States
facility: Investigational Site Number 840008
state: Florida
city: Winter Park
country: United States
facility: Investigational Site Number 840048
state: Florida
city: Mexico
country: United States
facility: Investigational Site Number 840024
state: Missouri
city: San Antonio
country: United States
facility: Investigational Site Number 840088
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: