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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.
Register: ClinicalTrials.gov
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
URL:  https://clinicaltrials.gov/show/NCT03885037
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Japan
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Affiliation: 
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
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
drug.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
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)
B5371006
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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