Trial · NCT03885089
Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
NCT03885089, Completed, Pfizer; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis). Trials, record NCT03885089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03885089
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
- NCT number
- NCT03885089
- Status
- Completed
- Enrollment
- 10 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, Erythrodermic Psoriasis
- Interventions
- Infliximab [infliximab biosimilar 3]
- First posted
- 2019-03-21
- Last updated
- 2025-06-19
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | 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. 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; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician. |
| Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | 30 weeks from the day of initial dose | Percentage of participants with a PASI75 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 75% improvement were calculated as PASI75. |
| Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | 30 weeks from the day of initial dose | Percentage of participants with a PASI90 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 90% improvement were calculated as PASI90. |
| Secondary | Change From Baseline in Body Surface Area Involvement (BSA) | 30 weeks from the day of initial dose | Summary statistics of the BSA at baseline, at study completion date, and the change in BSA from baseline to study completion date was presented. BSA was calculated from the percentage of skin rash to body surface area from baseline to study completion date, and change in severity of disease was evaluated. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Drug Reactions | 30 weeks from the day of initial dose | The safety analysis set (8 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 were excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | 30 weeks from the day of initial dose | The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI75 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | 30 weeks from the day of initial dose | The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI90 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Body Surface Area Involvement (BSA) | 30 weeks from the day of initial dose | The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, summary statistics and change from baseline in BSA as of the study completion date was calculated for the 1 participant whose BSA both at baseline and study completion date were available. | Percentage of BSA | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Drug Reactions | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 2 | Participants | ||
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 0.0 | 95% Confidence Interval 0.00 to 70.76 | Percentage of Participants | |
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 0.0 | 95% Confidence Interval 0.00 to 70.76 | Percentage of Participants | |
| Change From Baseline in Body Surface Area Involvement (BSA) | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | At baseline | 0.00 | Standard Deviation NA | Percentage of BSA |
| Change From Baseline in Body Surface Area Involvement (BSA) | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | At study completion date | 30.00 | Standard Deviation NA | Percentage of BSA |
| Change From Baseline in Body Surface Area Involvement (BSA) | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | Change | 30.00 | Standard Deviation NA | Percentage of BSA |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 10 | |
| Overall Study | COMPLETED | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 8 | |
| Overall Study | NOT COMPLETED | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 2 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 1 | 8 | |
| other | Headache | Nervous system disorders | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 1 | 8 | |
| other | Drug eruption | Skin and subcutaneous tissue disorders | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 1 | 8 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 1 | 8 | |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 1 | 8 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 0 | 8 |
| Total, other adverse events | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 3 | 8 |
| Total, serious adverse events | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03885089
GET https://conductscience.org/api/trials/v1/NCT03885089/registered