18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Drug Reactions (ADRs)Primary· 30 weeks from the day of initial dose
An 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. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar
ADR
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
3
serious ADR
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
1
Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP])Secondary· 30 weeks from the day of initial dose
The Disease Activity Score based on 28-joint count and C-reactive protein (DAS28 \[4/CRP\]) was calculated using four variables: Tender Joint Count (TJC28) and Swollen Joint Count (SJC28), both scored from 0 to 28; participant's overall activity assessed by the Visual Analog Scale (VAS, 0-100 mm); and C-reactive protein (CRP, ≥0 mg/dL). Higher scores indicate increased disease activity.
The formula is:
DAS28 (4/CRP) = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × LN((CRP) × 10 + 1) + 0.014 × (VAS) + 0.96.
Changes in DAS28 (4/CRP) from baseline to study completion were summarized as mean ± stan
Change in DAS28 (4/CRP): overall
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
-0.864
± 1.534
Change in DAS28 (4/CRP): no prior infliximab use
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
-1.184
± 1.715
Change in DAS28 (4/CRP): prior infliximab use
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
-0.175
± 0.689
Percentage of Participants With Remission (DAS28 [4/CRP])Secondary· 30 weeks from the day of initial dose
Percentage of participants with a remission based on DAS28 (4/CRP) was presented along with the two-sided 95% confidence interval (exact method).
For participants with available DAS28 (4/CRP) values both at baseline and study completion, the number and proportion of those who achieved remission (\<2.3) at both time points were calculated overall, as well as separately based on prior infliximab use before the initial dose of this drug.
Remission at baseline (overall)
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
36.6
22.12 – 53.06
Remission at baseline (no prior infliximab use)
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
25.0
10.69 – 44.87
Remission at baseline (prior infliximab use)
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
61.5
31.58 – 86.14
Remission at study completion date (overall)
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
61.0
44.50 – 75.80
Remission at study completion date (no prior infliximab use)
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
53.6
33.87 – 72.49
Remission at study completion date (prior infliximab use)
Group
Value
95% CI
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
76.9
46.19 – 94.96
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 weeks from the day of initial dose.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other trials of Infliximab [infliximab biosimilar 3]
Trials testing the same drug.
NCT03885089 — Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
· completed
NCT03884439 — Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)
· completed
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
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· recruiting
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· recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel
· EARLY_PHASE1
· recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
· Phase 1
· recruiting
Other Pfizer trials
Trials by the same sponsor.
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· not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta
· Phase 1
· not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 6 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03885037.