Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients, aged ≥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. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
You may not be if
Have experienced study treatment-limiting adverse events during induction treatment with study drug
* Cases of disease limited to the rectum extending \<15 cm past the anal verge are allowed to be included in study 1368.17
* Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines
Clareo Health | BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
