(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Budesonide MMX 6 mg Tablet; Placebo Tablet
Intervention description: Budesonide MMX 6 mg Tablet once daily.; Placebo Tablet once daily.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis

Summary:

      Randomized, double-blind, comparative study versus placebo performed in patients from studies
      CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who
      achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of
      treatment.

      Patients in remission at the End of Study visit will be given the opportunity to enter the
      12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study
      visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will
      be no interruption of study treatment between the parent studies and this study.

      It is planned that approximately 150 patients will be enrolled in the study. Patients will be
      randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective
      of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a
      day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical
      relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and
      stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI
      items).

      During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1,
      3, 6, 9, and 12 months of treatment.

      Patients will be contacted by telephone on a monthly basis for safety assessment. In case of
      occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled
      visit at any time during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.