N/A
Completed N=416
Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)
Source: ClinicalTrials.gov NCT03884439 ↗Enrolled (actual)
416
Serious AEs
0.8%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions — 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
7 | — |
| SECONDARY Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease |
84.1; 87.4 | — |
| SECONDARY Percentage of Participants With Improvement the Crohn's Disease Activity Index for Crohn's Disease |
6.6 | — |
| SECONDARY Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis |
43.7; 59.8 | — |
| SECONDARY Percentage of Participants With Improvement (Partial Mayo) Score for Ulcerative Colitis |
34.5 | — |
| SECONDARY Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis |
5.0; 3.1; -1.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03884439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.