An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

This is an observational prospective long-term exposure registry of adult participants with
moderate-to-severe ulcerative colitis. Two cohorts, a Simponi-exposed cohort and a comparator
cohort treated with thiopurines, will be enrolled in study. Approximately 6,000 participants
are planned for enrollment, with 3,000 participants in the Simponi-exposed cohort and 3,000
participants in the comparator cohort. Participants will receive treatments in a routine
clinical setting as prescribed by their physician. After enrollment, during the 10-year
follow-up period, a participant may stop his or her ulcerative colitis treatment regimen and
switch to a new treatment regimen. Lymphoma incidence will be primarily assessed by a
questionnaire that will be sent to the investigator to obtain complete medical information
about each case. An expert panel of medical specialists with extensive experience in lymphoma
will be convened to validate cases of lymphoma. Besides assessing the incidence of lymphoma,
long-term safety will be evaluated by capturing other adverse events of interest and serious
adverse events.

Inclusion Criteria:

- Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to
enrollment, confirmed by endoscopy at any time in the past

- For enrollment into the Simponi-exposed cohort meets one of the following:

1. The participant is currently receiving Simponi ,or

2. The participant is continuing to receive Simponi after participation in an
ulcerative colitis study, or

3. The participant is scheduled to receive Simponi within 30 days after enrollment

- For Comparator cohort:

1. The participant is currently receiving thiopurines, having received at least 12
consecutive weeks of therapy prior to registry entry

2. Participant must not be receiving other approved biologic agents, including
Simponi, or any investigational agents at enrollment

3. Participant may have received biologics other than Simponi or investigational
agents prior to enrollment

Exclusion Criteria:

- Participants who cannot be treated with Simponi or thiopurines

- Participants with a previous diagnosis of lymphoma or hematologic malignancy at any
time prior to enrollment

- Participants currently receiving an investigational or biologic agent other than
Simponi

- Participants with any condition for which, in the opinion of the investigator,
participation in the registry would not be in the best interest of the participant or
that could prevent, limit, or confound the protocol-specified assessments