N/A
Completed N=348
Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)
Source: ClinicalTrials.gov NCT00724958 ↗Enrolled (actual)
348
Serious AEs
12.5%
Results posted
Oct 2011
Primary outcomePrimary: Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) — 16.89; 34.74; 63.22; 62.86 Days
Summary
The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) |
16.89; 34.74; 63.22; 62.86; 61.30; 60.95 | — |
| PRIMARY Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) |
14.00; 28.00; 56.00; 57.00; 57.00; 56.00 | — |
| PRIMARY Average Dose of Infliximab Per Participant Within the Observation Period |
5.09; 5.04; 5.06; 5.11; 5.20; 5.17 | — |
| PRIMARY Median Dose of Infliximab Per Participant Within the Observation Period |
5.09; 5.00; 5.00; 5.00; 5.00; 5.00 | — |
| PRIMARY Total Dose of Infliximab Per Participant Within the Observation Period |
2290.32 | — |
| SECONDARY Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. |
8.25; 3.46; 2.21; 2.40; 2.70; 3.38 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with active luminal and/or fistulizing CD.
Exclusion Criteria
- Per summary of product characteristics.
Data sourced from ClinicalTrials.gov (NCT00724958). 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.