Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

Pfizer

Status: Completed

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Infliximab [infliximab biosimilar 3]

Study type: Observational

Funder types: Industry

Identifiers

NCT03884439

B5371008

Details and patient eligibility

About

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.

Full description

This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for Crohn's disease or ulcerative colitis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

Enrollment: 428 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with Crohn's disease or ulcerative colitis who started treatment with this drug
• Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Trial design

428 participants in 1 patient group

Infliximab [infliximab biosimilar 3]

Description:

Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Treatment:

Drug: Infliximab [infliximab biosimilar 3]