Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bausch Health Americas, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients fulfilling the following criteria are eligible for participation in the study:
* Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
* Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
* Patients who have completed all End of Study assessments for the CB-01-02/01, CB-01-02/02 and CB-01-02/06 studies.
* Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.
You may not be if
Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
* Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
* Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability \[score 0 for mucosal appearance\]).
* Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.
Clareo Health | (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
