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

• ClinicalTrials.gov Identifier: NCT03884439
• Recruitment Status: Enrolling by invitation
• First Posted: March 21, 2019
• Last Update Posted: April 4, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Crohn's Disease; Ulcerative Colitis	Drug: Infliximab [infliximab biosimilar 3]

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
• Actual Study Start Date: March 18, 2019
• Estimated Primary Completion Date: February 13, 2024
• Estimated Study Completion Date: February 13, 2024

Groups and Cohorts

Group/Cohort

Intervention/treatment

Infliximab [infliximab biosimilar 3]; Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Drug: Infliximab [infliximab biosimilar 3]; <Crohn's disease> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. <Ulcerative colitis> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter.; Other Name: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse drug reactions [ Time Frame: 30 weeks from the day of initial dose ]

Secondary Outcome Measures :

1. Percentage of Participants With Remission (Clinical Disease Activity Index (CDAI)) for Crohn's disease [ Time Frame: Week 30 ]
2. Percentage of Participants With Improvement (Clinical Disease Activity Index (CDAI)) for Crohn's disease [ Time Frame: Week 30 ]
3. Percentage of Participants With Remission (Mayo) score for ulcerative colitis [ Time Frame: Week 30 ]
4. Percentage of Participants With Improvement (Mayo) score for ulcerative colitis [ Time Frame: Week 30 ]
5. Partial mayo Score [ Time Frame: Baseline, Week 30 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

Japan

Pfizer Local Country Office

Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03884439
• Other Study ID Numbers: B5371008
• First Posted: March 21, 2019
• Last Update Posted: April 4, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Keywords provided by Pfizer:

Crohn's Disease; Ulcerative Colitis; Infliximab; biosimilar

Additional relevant MeSH terms:

Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Pathologic Processes; Infliximab; Dermatologic Agents; Gastrointestinal Agents; Antirheumatic Agents