Trial Outcomes & Findings for Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis) (NCT NCT03884439)

Last Updated: 2025-03-21

Results Overview

An adverse drug reaction (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. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

428 participants

Primary outcome timeframe

30 weeks from the day of initial dose

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] Participants with Crohn's disease or Ulcerative colitis 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	416
Overall Study COMPLETED	371
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] Participants with Crohn's disease or Ulcerative colitis 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 No informed consent for publication of study results	38
Overall Study Contract violation/deficiency	7

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=371 Participants Participants with Crohn's disease or Ulcerative colitis 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=371 Participants
Age, Customized ≥15 and <65 years	353 Participants n=371 Participants
Age, Customized ≥65 years	18 Participants n=371 Participants
Sex: Female, Male Female	100 Participants n=371 Participants
Sex: Female, Male Male	271 Participants n=371 Participants

PRIMARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The safety analysis set (371 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 no informed consent for publication of study results and contract violation/deficiency were excluded.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=371 Participants Participants with Crohn's disease or Ulcerative colitis 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	7 Participants

SECONDARY outcome

Timeframe: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Crohn's disease as of the end date of the study was calculated for the 151 participants whose effectiveness was evaluated by the CDAI score.

Percentage of participants with remission of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items: (1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). A Crohn's Disease Activity IndexI score of \<150 was considered remission.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=151 Participants Participants with Crohn's disease or Ulcerative colitis 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 (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease At baseline	84.1 Percentage of participants Interval 77.28 to 89.54
Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease At study completion date	87.4 Percentage of participants Interval 81.05 to 92.25

SECONDARY outcome

Timeframe: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Percentage of participants with improvement of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items:(1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). The Crohn's Disease Activity Index improvement was defined as a decrease of 25% or more and 70 points or more in Crohn's Disease Activity Index score after treatment with Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] compared with the Crohn's Disease Activity Index score before treatment.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=151 Participants Participants with Crohn's disease or Ulcerative colitis 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 Improvement the Crohn's Disease Activity Index for Crohn's Disease	6.6 Percentage of participants Interval 3.22 to 11.84

SECONDARY outcome

Timeframe: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Ulcerative colitis as of the end date of the study was calculated for the 87 participants whose effectiveness was evaluated by the partial Mayo score.

Percentage of participants with remission of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score of \<2 was considered partial Mayo score remission.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=87 Participants Participants with Crohn's disease or Ulcerative colitis 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 (Partial Mayo) Score for Ulcerative Colitis At baseline	43.7 Percentage of participants Interval 33.06 to 54.74
Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis At study completion date	59.8 Percentage of participants Interval 48.71 to 70.15

SECONDARY outcome

Timeframe: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Ulcerative colitis as of the end date of the study was calculated for the 87 participants whose effectiveness was evaluated by the partial Mayo score.

Percentage of participants with improvement of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score improvement was defined as 2 points or more reduction from baseline.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=87 Participants Participants with Crohn's disease or Ulcerative colitis 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 Improvement (Partial Mayo) Score for Ulcerative Colitis	34.5 Percentage of participants Interval 24.61 to 45.44

SECONDARY outcome

Timeframe: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, summary statistics and change of the Mayo score was calculated for the 15 participants with Ulcerative colitis whose effectiveness was evaluated by the Mayo score.

Summary statistics of the Mayo score at baseline, at study completion date, and the change in Mayo score from baseline to study completion date in participants with Ulcerative colitis. The Mayo score consists of 4 domains, each scored as a 0- to 3-point subscore, with higher scores indicating more severe disease activity. The 4 domains are the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), endoscopic finding subscore (0 to 3), and physician's global assessment subscore (0 to 3). The method of calculating the Mayo score is the sum of all subscores in the 4 domains, with a range of 0 to 12 points.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=15 Participants Participants with Crohn's disease or Ulcerative colitis 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 of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis At baseline	5.0 Points on a scale Standard Deviation 3.7
Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis At study completion date	3.1 Points on a scale Standard Deviation 3.5
Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis Change	-1.9 Points on a scale Standard Deviation 2.7

Adverse Events

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

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=371 participants at risk Participants with Crohn's disease or Ulcerative colitis 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.
Hepatobiliary disorders Cholelithiasis	0.27% 1/371 • 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.
Infections and infestations Appendicitis	0.27% 1/371 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.27% 1/371 • 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=371 participants at risk Participants with Crohn's disease or Ulcerative colitis 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.
Cardiac disorders Tachycardia	0.27% 1/371 • 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.
Ear and labyrinth disorders Auricular swelling	0.27% 1/371 • 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.
Gastrointestinal disorders Anal fistula	0.27% 1/371 • 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.
Gastrointestinal disorders Intestinal stenosis	0.27% 1/371 • 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.
General disorders Malaise	0.27% 1/371 • 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.
General disorders Pyrexia	0.54% 2/371 • 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.
Metabolism and nutrition disorders Diabetes mellitus	0.27% 1/371 • 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.
Renal and urinary disorders Tubulointerstitial nephritis	0.27% 1/371 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 1/371 • 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 Papule	0.27% 1/371 • 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 Psoriasis	0.27% 1/371 • 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	0.27% 1/371 • 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 Urticaria	0.27% 1/371 • 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