Ulcerative Colitis
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria -Participants from Study AMAC or AMBG who have had at least one study drug administration and have not had early termination of study drug. -Female participants must agree to contraception requirements.
Exclusion criteria
Exclusion criteria: -Participants must not have developed a new condition, including cancer in the originator study. -Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study -Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study. -Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants in Clinical Remission | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Percentage of Participants in Endoscopic Remission. -Percentage of Participants in Corticosteroid-free Remission . -Percentage of Participants with Mucosal Healing at Week 52. -Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score . -Percentage of Participants Who are Hospitalized Due to UC . -Percentage of Participants Who Undergo UC Surgeries Including Colectomy | — |
Countries
Asia except Japan, Europe, Japan, Middle East, North America, Oceania, South America
Outcome results
None listed