Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

An observational study of Crohn's Disease and Ulcerative Colitis, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use. Read more about this study

Who is it for?: Ages 0 years and older
Conditions the study is for: Crohn's Disease, Ulcerative Colitis
What is being tested?: Infliximab [infliximab biosimilar 3]
Type of treatment: Injection or infusion
How many people: 428 participants
Where: 1 siteJapan
Study dates: 18 Mar 2019to 2 Feb 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Who may be able to join

Patients with Crohn's disease or ulcerative colitis who started treatment with this drug
Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Local Country Office
Tokyo

Other trials in Japan

About this study

Official title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.

Read the detailed description

This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for Crohn's disease or ulcerative colitis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

Conditions: Crohn's Disease, Ulcerative Colitis
Being tested: Infliximab [infliximab biosimilar 3]
Keywords: Crohn's Disease, Ulcerative Colitis, Infliximab, biosimilar
Medical subject headings: Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Infliximab [infliximab biosimilar 3]Drug
Also called Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"
<Crohn's disease> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. <Ulcerative colitis> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter.

Study groups in NCT03884439
Study group	Role	What they receive
Infliximab [infliximab biosimilar 3]		Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS Receives: Drug: Infliximab [infliximab biosimilar 3]

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Drug Reactions
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.
Measured: 30 weeks from the day of initial dose

Secondary outcomes (5)

Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease
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.
Measured: Baseline, 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 the Crohn's Disease Activity Index for Crohn's Disease
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.
Measured: 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 Remission (Partial Mayo) Score for Ulcerative Colitis
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.
Measured: Baseline, 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 (Partial Mayo) Score for Ulcerative Colitis
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.
Measured: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis
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.
Measured: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 20192 Feb 2024

First posted21 Mar 2019
Study start18 Mar 2019
Primary completion2 Feb 2024
Study completion2 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Other
Enrolment: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03884439
Sponsor's protocol ID: B5371008
Status last verified: Mar 2025
First submitted: 4 Mar 2019
Last updated: 21 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
ClinicalTrials.gov ID: NCT03884439
Acronym / sponsor ID: B5371008
Conditions: Crohn's Disease, Ulcerative Colitis
Keywords: Crohn's Disease, Ulcerative Colitis, Infliximab, biosimilar
Study type: Observational
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 18 Mar 2019 (actual)
Primary completion: 2 Feb 2024 (actual)
Study completion: 2 Feb 2024 (actual)
First posted: 21 Mar 2019 (actual)
Results: Posted 21 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.

Detailed description

This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.

Therefore, Time Perspective is retrospective and prospective.

Study design

Observational model: Case only
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Infliximab [infliximab biosimilar 3]	–	Drug: Infliximab [infliximab biosimilar 3]Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Key inclusion criteria (2 listed)

Patients with Crohn's disease or ulcerative colitis who started treatment with this drug
Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Infliximab [infliximab biosimilar 3]Also: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"<Crohn's disease> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. <Ulcerative colitis> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter.	Drug	Infliximab [infliximab biosimilar 3]

Primary outcome

Number of Participants With Adverse Drug Reactions
Time frame: 30 weeks from the day of initial dose
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.

5 secondary outcomes

Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease
Time frame: Baseline, 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 the Crohn's Disease Activity Index for Crohn's Disease
Time frame: 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 Remission (Partial Mayo) Score for Ulcerative Colitis
Time frame: Baseline, 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 (Partial Mayo) Score for Ulcerative Colitis
Time frame: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.
Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis
Time frame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Results and safety

Results posted to the registry on 21 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]	416	371

Primary outcome: Number of Participants With Adverse Drug Reactions

Time frame: 30 weeks from the day of initial dose. Count of participants. Unit: Participants

Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n = 371
Value	7

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 weeks from the day of initial dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]	3 of 371 (0.8%)	12 of 371 (3.2%)	0 of 371

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease and Ulcerative Colitis, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (time frame: 30 weeks from the day of initial dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03884439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.