Trial Outcomes & Findings for Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis) (NCT NCT03885037)

Results Overview

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 \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed.

Recruitment status

COMPLETED

Target enrollment

77 participants

Primary outcome timeframe

30 weeks from the day of initial dose

Results posted on

2026-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] Participants with rheumatoid arthritis (RA) who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	77
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] Participants with rheumatoid arthritis (RA) who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Overall Study Protocol Violation	16

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=61 Participants Participants with RA who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	0 participants n=61 Participants
Age, Customized ≥15 and <65 years	29 participants n=61 Participants
Age, Customized ≥65 years	32 participants n=61 Participants
Sex: Female, Male Female	42 Participants n=61 Participants
Sex: Female, Male Male	19 Participants n=61 Participants

PRIMARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The safety analysis set (61 participants) comprised of participants who satisfied the inclusion criteria and had received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\]. Participants with protocol violation were excluded.

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 \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=61 Participants Participants with RA who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions (ADRs) ADR	3 Participants
Number of Participants With Adverse Drug Reactions (ADRs) serious ADR	1 Participants

SECONDARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The efficacy analysis set (54 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 54 participants, 41 participants who had DAS28 (4/CRP) available both at baseline and study completion were evaluated the disease activity at the time of study completion. Among the 41 participants, 28 had no prior use of infliximab products, while 13 had used them before.

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 ± standard deviation, overall, as well as separately based on prior infliximab use before the initial dose of this drug. Greater negative changes reflect larger reductions in disease activity.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=41 Participants Participants with RA who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP]) Change in DAS28 (4/CRP): overall	-0.864 Scores of DAS28 (4/CRP) Standard Deviation 1.534
Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP]) Change in DAS28 (4/CRP): no prior infliximab use	-1.184 Scores of DAS28 (4/CRP) Standard Deviation 1.715
Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP]) Change in DAS28 (4/CRP): prior infliximab use	-0.175 Scores of DAS28 (4/CRP) Standard Deviation 0.689

SECONDARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The efficacy analysis set (54 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 54 participants, the percentage of participants who achieved remission (\< 2.3) as of the study completion date was calculated for the 41 participants whose DAS28 (4/CRP) were available both at baseline and study completion. Among the 41 participants, 28 had no prior use of infliximab products, while 13 had used them before.

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.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=41 Participants Participants with RA who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Remission (DAS28 [4/CRP]) Remission at baseline (overall)	36.6 Percentage of Participants Interval 22.12 to 53.06
Percentage of Participants With Remission (DAS28 [4/CRP]) Remission at baseline (no prior infliximab use)	25.0 Percentage of Participants Interval 10.69 to 44.87
Percentage of Participants With Remission (DAS28 [4/CRP]) Remission at baseline (prior infliximab use)	61.5 Percentage of Participants Interval 31.58 to 86.14
Percentage of Participants With Remission (DAS28 [4/CRP]) Remission at study completion date (overall)	61.0 Percentage of Participants Interval 44.5 to 75.8
Percentage of Participants With Remission (DAS28 [4/CRP]) Remission at study completion date (no prior infliximab use)	53.6 Percentage of Participants Interval 33.87 to 72.49
Percentage of Participants With Remission (DAS28 [4/CRP]) Remission at study completion date (prior infliximab use)	76.9 Percentage of Participants Interval 46.19 to 94.96

Adverse Events

Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=61 participants at risk Participants with RA who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Nervous system disorders Altered state of consciousness	1.6% 1/61 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=61 participants at risk Participants with RA who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Infections and infestations Herpes zoster	1.6% 1/61 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Rash	1.6% 1/61 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER