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

NCT03884439 | Completed Results

• 1 other identifier: B5371008
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Crohn's Disease; Ulcerative Colitis; Infliximab; biosimilar

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Drug Reactions

  An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.

  30 weeks from the day of initial dose

Secondary Outcomes (5)

• Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease

  Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

• Percentage of Participants With Improvement the Crohn's Disease Activity Index for Crohn's Disease

  Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

• Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis

  Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

• Percentage of Participants With Improvement (Partial Mayo) Score for Ulcerative Colitis

  Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

• Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis

  Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Study Arms (1)

Infliximab [infliximab biosimilar 3]

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

Drug: Infliximab [infliximab biosimilar 3]

Interventions

Infliximab [infliximab biosimilar 3] DRUG

\<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.

Also known as: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"

Infliximab [infliximab biosimilar 3]

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Local Country Office

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 21, 2019
• Study Start: March 18, 2019
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)