N/A
Completed N=77
Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03885037 ↗
Enrolled (actual)
77
Serious AEs
1.6%
Results posted
Jan 2026
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions (ADRs) — 3; 1 Participants
Summary
To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against rheumatoid arthritis under actual status of use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions (ADRs) |
3; 1 | — |
| SECONDARY Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP]) |
-0.864; -1.184; -0.175 | — |
| SECONDARY Percentage of Participants With Remission (DAS28 [4/CRP]) |
36.6; 25.0; 61.5; 61.0; 53.6; 76.9 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03885037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.