Corrona Inflammatory Bowel Disease (IBD) Registry

The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a
national cohort of patients with IBD. The diseases under study include Crohn's Disease (CD),
Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better
characterize the natural history of the disease and to extensively evaluate the effectiveness
and safety of medications approved for the treatment of IBD. This will be done through the
standardized collection of validated patient-reported outcomes (PRO) and clinician-reported
outcomes (ClinRO), the prevalence and incidence of comorbidities and adverse events,
medication utilization patterns, and patient productivity measures.

The design is a prospective, non-interventional registry for patients with IBD under the care
of a certified gastroenterologist. Longitudinal follow-up data is collected from both
patients and their treating gastroenterologist during routine clinical encounters using
Corrona registry questionnaires. These questionnaires collect data on patient demographics,
disease duration, medical history (including all prior and current treatments for IBD),
smoking status, alcohol use, disease activity and severity, pain, as well as other clinician-
and patient-reported outcomes, comorbidities and adverse events, infections,
hospitalizations, and other targeted safety outcomes.

After the enrollment visit, IBD patients and physicians will complete the follow-up
questionnaires during regularly scheduled clinical encounters. The goal is to collect data
from patients and providers at six month intervals, not to exceed 2 visits in any 12 month
period.

Adverse events may be volunteered spontaneously by the subject, or be discovered as a result
of general questioning by the Investigator. During all Corrona related visits with the
Investigator, subjects will be questioned regarding the occurrence of adverse events.

ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the Corrona IBD Registry, a
patient must satisfy all of the inclusion criteria and none of the exclusion criteria
listed below.

Inclusion Criteria:

- At least 18 years of age or older.

- Willing and able to provide written consent for participation in the IBD Registry.

- Willing and able to provide Personally Identifiable Information (PII) which includes
the following types of personal information at a minimum: full name, date of birth,
sex, and home address zip code.

- Diagnosis of one of the following by a gastroenterologist:

1. Crohn's disease

2. Ulcerative colitis

- Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor
(Tofacitinib) for the treatment of UC or Crohn's disease.

Exclusion Criteria:

• Participating in or planning to participate in a clinical trial (Phase I - III) or a
post-marketing study or registry (i.e. phase IV).∆

Eligible Medications Grouped by Drug Class & Diagnosis

ANTI-TNF AGENTS AND BIOSIMILARS - Adalimumab (HUMIRA), Adalimumab-atto (AMJEVITA),
Certolizumab pegol (CIMZIA), Golimumab (SIMPONI), Infliximab (REMICADE), Infliximab-dyyb
(INFLECTRA)

INTEGRIN RECEPTOR ANTAGONISTS - Natalizumab (TYSABRI), Vedolizumab (ENTYVIO)

INTERLEUKIN ANTAGONIST (IL-12 AND IL-23), Ustekinumab (STELARA),

JAK INHIBITOR - Tofacitinib (XELJANZ)

∆ Once clinical trial participation has ended, a patient is permitted to enroll in the
registry if they satisfy the eligibility requirements.

∗ These criteria are subject to change with the needs of the registry at the sole
discretion of the Sponsor (Corrona).