Arthritis, RheumatoidNCT05796245
A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis
An observational study of Arthritis, Rheumatoid and Colitis, Ulcerative, run by Pfizer at 1 site in Japan.
Trial summary
The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis. RA is a kind of joint disease that causes pain and swelling. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease
- How many people
- 2,207 participants
- Where
- 1 siteJapan
- Study dates
- 1 Dec 2023to 14 Mar 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes individuals who have a diagnosis of rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis and have been exposed to Infliximab-Pfizer Biosimilar or the innovator (Remicade) with a planned study period between December 1, 2018 and November 30, 2023.
Who may be able to join
- Have at least 90 days of look-back period
- Have diagnostic code of indicated diseases (rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis) in the 90-day look-back period. Patients with >1 indication will be summarized as a separate group from each sub-cohort. An inpatient or outpatient visit assigned a diagnosis code consistent with either rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis using ICD-10 coding.
- 15 years of age or older at the time of index date
Who cannot join
- 1. Patients with pre-existing safety outcome event during the 90-day look-back period will be excluded from the study cohort for that specific outcome event as this study is observing incident cases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infliximab-Pfizer Biosimilar Post-Marketing Database Study
The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis.
RA is a kind of joint disease that causes pain and swelling.
Read more
UC causes inflammation and sores (also called ulcers), in the lining of the rectum and colon.
Chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract.
Psoriasis is a skin disease that gives you a dry, scaly rash.
The study includes patient's data from the database who:
- Have at least 90 days of look-back period
- Have any of these diseases (RA, UC, Crohn's disease, or Psoriasis) in the 90-day look back period
- Are 15 years of age or older at the time of first dosing
All the patient's data included in this study would have received infliximab as intravenous (into veins) injection.
- Conditions
- Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease, Psoriasis
- Keywords
- Tumor Necrosis Factor, TNF, Infliximab, Biosimilar
- Medical subject headings
- Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] | Not described | |
| Remicade | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Serious Infections
The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years.
Measured: From index date up to 60 days after last dose
Secondary outcomes (4)
Incidence Rate of Tuberculosis
The observation of tuberculosis was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
For the full analysis set, 0 and 14 events occurred with a total of 161.8 and 2904.1 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 0 and 14 events occurred with a total of 27.2 and 2904.1 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 14.3 events occurred with a total of 10.4 and 2889.7 person-years. For the comparative matched analysis set, 0 and 1 event occurred with a total of 27.2 and 50.1 person-years.
Measured: From index date up to 60 days after last dose
Incidence Rate of Serious Blood Disorder
The observation of serious blood disorder was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
For the full analysis set, 1 and 15 events occurred with a total of 163.5 and 2913.5 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 15 events occurred with a total of 27.5 and 2913.5 person-years. For the comparative analysis set (IPTW weighted), 0.1 and 14.9 events occurred with a total of 10.4 and 2899.6 person-years. For the comparative matched analysis set, 1 and 0 events occurred with a total of 27.5 and 52.5 person-years.
Measured: From index date up to 60 days after last dose
Incidence Rate of Interstitial Pneumonia
The observation of interstitial pneumonia was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
For the full analysis set, 5 and 42 events occurred with a total of 157.1 and 2918.8 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 42 events occurred with a total of 26.2 and 2918.8 person-years. For the comparative analysis set (IPTW weighted), 0.3 and 42.1 events occurred with a total of 10.1 and 2905.0 person-years. For the comparative matched analysis set, 1 and 1 event occurred with a total of 26.2 and 52.5 person-years.
Measured: From index date up to 60 days after last dose
Incidence Rate of Malignancy
This study analyzed malignancy by extending follow-up time until the first incident event, death, end of the study period, or loss to follow-up. The primary analysis utilized an ever-exposed approach whereby a person always was considered exposed to the initial treatment. All malignancies were reported in the primary analysis even those that occur after the day of initial treatment. Additionally, two types of analyses based on propensity score were conducted.
For the full analysis set, 7 and 77 events occurred with a total of 172.5 and 4480.2 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 77 events occurred with a total of 27.7 and 4480.2 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 76.7 events occurred with a total of 10.5 and 4458.5 person-years. For the comparative matched analysis set, 1 and 4 events occurred with a total of 27.7 and 78.4 person-years.
Measured: From index date up to the first incident event, death, end of the study period, or loss to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Dec 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 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 Arthritis, RheumatoidStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796245
- Sponsor's protocol ID
- B5371010
- Other IDs
- NCT05796245
- Status last verified
- Jun 2025
- First submitted
- 2 Mar 2023
- Last updated
- 4 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab-Pfizer Biosimilar Post-Marketing Database Study
- ClinicalTrials.gov ID
- NCT05796245
- Acronym / sponsor ID
- B5371010
- Conditions
- Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease, Psoriasis
- Keywords
- Tumor Necrosis Factor, TNF, Infliximab, Biosimilar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,207 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis.
RA is a kind of joint disease that causes pain and swelling.
UC causes inflammation and sores (also called ulcers), in the lining of the rectum and colon.
Chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract.
Psoriasis is a skin disease that gives you a dry, scaly rash.
The study includes patient's data from the database who:
- Have at least 90 days of look-back period
- Have any of these diseases (RA, UC, Crohn's disease, or Psoriasis) in the 90-day look back period
- Are 15 years of age or older at the time of first dosing
All the patient's data included in this study would have received infliximab as intravenous (into veins) injection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] | – | – |
| Remicade | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes individuals who have a diagnosis of rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis and have been exposed to Infliximab-Pfizer Biosimilar or the innovator (Remicade) with a planned study period between December 1, 2018 and November 30, 2023.
Key inclusion criteria (3 listed)
- Have at least 90 days of look-back period
- Have diagnostic code of indicated diseases (rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis) in the 90-day look-back period. Patients with >1 indication will be summarized as a separate group from each sub-cohort. An inpatient or outpatient visit assigned a diagnosis code consistent with either rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis using ICD-10 coding.
- 15 years of age or older at the time of index date
Key exclusion criteria (1 listed)
- 1. Patients with pre-existing safety outcome event during the 90-day look-back period will be excluded from the study cohort for that specific outcome event as this study is observing incident cases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Rate of Serious Infections
Time frame: From index date up to 60 days after last dose
The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years.
4 secondary outcomes
Incidence Rate of Tuberculosis
Time frame: From index date up to 60 days after last dose
Incidence Rate of Serious Blood Disorder
Time frame: From index date up to 60 days after last dose
Incidence Rate of Interstitial Pneumonia
Time frame: From index date up to 60 days after last dose
Incidence Rate of Malignancy
Time frame: From index date up to the first incident event, death, end of the study period, or loss to follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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 Arthritis, Rheumatoid and Colitis, Ulcerative, 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 3 inclusion and 1 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 4 Jun 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 4 Jun 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?
Incidence Rate of Serious Infections (time frame: From index date up to 60 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.