Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: MMX mesalamine/ mesalazine
Intervention description: 4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
Intervention MeSH terms: Mesalamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 759.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was designed to evaluate if subjects who achieve complete remission after 8 weeks
      of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term
      outcomes and remain in remission longer compared with subjects who demonstrate only partial
      remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore,
      subjects who achieve either complete or partial remission will enter into a 12-month
      maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given
      QD. Remission status for the 2 groups will be evaluated and compared at the end of this
      12-month maintenance period. The data obtained from this study will provide scientifically
      meaningful information to demonstrate that achieving complete remission (clinical and
      endoscopic remission) is important for a better long-term prognosis, or that the current
      paradigm of symptomatic treatment is appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults aged 18 or older

          2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable
             contraceptive requirements of the protocol

          3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)

          4. Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX
             mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.

        Exclusion Criteria:

          1. Severe UC

          2. Acute flare with onset greater than >6 weeks prior to baseline while on maintenance
             therapy. There is no limit to the onset of flare prior to baseline if the flare is
             untreated.

          3. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant
             XL, Mezavant LP)

          4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2 g/day

          5. Acute flare on a 5-ASA maintenance therapy of >3.2 g/day

          6. Systemic or rectal steroids use within the 4 weeks prior to screening or
             immunosuppressants within the last 6 weeks prior to screening

          7. History of biologic (anti-TNF agent) use

          8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the
             prescribed over-the-counter dose) of any anti-inflammatory drugs, including
             non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen,
             within 7 days prior to screening. However, prophylactic use of a stable dose of
             aspirin up to 325mg/day for cardiac disease is permitted

          9. Current or recurrent disease, other than UC, that could affect the colon, the action,
             absorption, or disposition of the IMP, or clinical or laboratory assessments