Colitis, Ulcerative
Conditions
Brief summary
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Interventions
DRUGSPD476 (mesalazine)
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit * Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase * Women of childbearing potential must use an acceptable contraceptive method while on study treatment
Exclusion criteria
* Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events | Throughout the study period of approximately 2 year, 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to relapse | Up to 12-14 months |
| Participant compliance | Up to 12-14 months |
| Number of participants in remission | 12 months |
| Ulcerative colitis disease activity index (UC-DAI) score | Baseline, Month 2, and Month 12 |
| Patient questionnaire | Month 6, and Month 12 |
Outcome results
None listed