Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

Inclusion Criteria

• •1. An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.
• •2. Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants:
• •a. Participant is a male or,
• •If the participant is female, she is eligible to enter if she is of:
• •Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization \[hysterectomy or bilateral tubal ligation\] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
• •i) Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month Treatment Phase, and the 2-week follow-up phase.
• •ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.
• •iii) An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than (\<)1% per year (not all IUDs meet this criterion).
• •iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion.
• •v) Partner has undergone vasectomy and participant is in a monogamous relationship.
• •The investigator is responsible for determining whether the participant has adequate birth control for study participation.
• •b. Participant is greater than or equal to (≥) 18 years of age. c. Participant has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed participants) of mild to moderate UC in remission for greater than (\>) 1 month and \<12 months.
• •d. Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 = Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage.
• •3. Participant and investigator consider there is the potential for benefit to the participant with MP treatment.
• •4. Participant is capable and willing to comply with all study procedures.