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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT03885037 |
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Date of registration:
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04/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
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Scientific title:
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Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis) |
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Date of first enrolment:
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March 20, 2019 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03885037 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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1-800-718-1021 |
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Email:
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ClinicalTrials.gov_Inquiries@pfizer.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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:
0 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Infliximab [infliximab biosimilar 3]
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Primary Outcome(s)
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Incidence of adverse drug reactions
[Time Frame: 30 weeks from the day of initial dose]
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Secondary Outcome(s)
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Percentage of Participants With Remission (DAS28-4[CRP])
[Time Frame: Baseline, Week30]
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Disease Activity Score Based on 28-joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
[Time Frame: Week 30]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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