Clinical trial NCT03884439: Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)
Official title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's Disease
Ulcerative Colitis
Infliximab
biosimilar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 428
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: 30 weeks from the day of initial dose
Secondary outcomes:
measure: Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease
timeFrame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
measure: Percentage of Participants With Improvement the Crohn's Disease Activity Index for Crohn's Disease
timeFrame: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
measure: Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis
timeFrame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
measure: Percentage of Participants With Improvement (Partial Mayo) Score for Ulcerative Colitis
timeFrame: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
measure: Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis
timeFrame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: