Ulcerative colitis
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, aged equal to or more than 18 years - Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial - Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. - Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
Exclusion criteria
Exclusion criteria: - Have experienced study treatment-limiting adverse events during induction treatment with study drug - Have developed any of the exclusion criteria from the original induction study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) [ Time Frame: Up to week 336 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Proportion of patients with clinical remission [ Time Frame: Up to 336 weeks ] | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed