N/A
N=2,207
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
Arthritis, Rheumatoid · Colitis, Ulcerative · Crohn Disease · Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05796245 ↗Enrolled (actual)
2,207
Serious AEs
—
Results posted
Jun 2025
Primary outcome: Primary: Incidence Rate of Serious Infections — 0.06; 0.09; 0.22; 0.09 serious infections per 1 person-year
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Serious Infections |
0.06; 0.09; 0.22; 0.09; 0.13; 0.09 | — |
| SECONDARY Incidence Rate of Tuberculosis |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Incidence Rate of Serious Blood Disorder |
0.01; 0.01; 0.04; 0.01; 0.01; 0.01 | — |
| SECONDARY Incidence Rate of Interstitial Pneumonia |
0.03; 0.01; 0.04; 0.01; 0.03; 0.01 | — |
| SECONDARY Incidence Rate of Malignancy |
0.04; 0.02; 0.04; 0.02; 0.00; 0.02 | — |
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.
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05796245). 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.