N/A
Completed N=4,485
Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)
Arthritis, Rheumatoid · Spondylitis, Ankylosing · Arthritis, Psoriatic · Psoriasis
Source: ClinicalTrials.gov NCT00727298 ↗
Enrolled (actual)
4,485
Serious AEs
6.6%
Results posted
Sep 2012
Primary outcomePrimary: Number of Participants Experiencing at Least One Adverse Event — 609 Participants
Summary
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing at Least One Adverse Event |
609 | — |
| SECONDARY Clinicians' Impression of Disease Severity From Baseline to Week 102 |
0.7; 1.3; 4.9; 17.6; 51.2; 21.0 | — |
| SECONDARY Clinicians' Impression of Therapeutic Efficacy |
34.8; 8.9; 1.4; 17.4; 37.3; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
- Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00727298). 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.