World Health Organization site
Skip Navigation Links

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT03885037
Date of registration: 04/03/2019
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
Scientific title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)
Date of first enrolment: March 20, 2019
Target sample size: 300
Recruitment status: Recruiting
Study type:  Observational
Study design:   
Countries of recruitment
Name:     Pfizer Call Center
Telephone: 1-800-718-1021
Name:     Pfizer Call Center
Affiliation:  Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with rheumatoid arthritis who started treatment with this drug

- Patients who received this drug for the first time after the day of launch of this

Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Infliximab [infliximab biosimilar 3]
Primary Outcome(s)
Incidence of adverse drug reactions [Time Frame: 30 weeks from the day of initial dose]
Secondary Outcome(s)
Disease Activity Score Based on 28-joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Time Frame: Week 30]
Percentage of Participants With Remission (DAS28-4[CRP]) [Time Frame: Baseline, Week30]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history