N/A
Completed N=516
Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)
Source: ClinicalTrials.gov NCT00725621 ↗Enrolled (actual)
516
Serious AEs
4.1%
Results posted
Aug 2011
Primary outcomePrimary: Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy — 56.48; 56.32; 56.75; 57.55 Days
Summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy |
56.48; 56.32; 56.75; 57.55; 56.83; 58.73 | — |
| PRIMARY Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy |
57.00; 57.00; 57.00; 57.00; 57.00; 57.00 | — |
| PRIMARY Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy |
3.42; 3.50; 3.30; 3.43; 3.51; 3.31 | — |
| PRIMARY Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy |
3.33; 3.38; 3.23; 3.33; 3.39; 3.23 | — |
| PRIMARY Mean Remicade Dose Per Participant |
3.56 | — |
| PRIMARY Median Remicade Dose Per Participant |
3.49 | — |
| SECONDARY Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy |
8.02 | — |
| SECONDARY Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) |
470; 111; 138 | — |
| SECONDARY Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) |
31.25; 31.59; 58.96; 42.46 | — |
| SECONDARY Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS |
43.89; 45.12; 67.10; 46.18 | — |
Eligibility Criteria
Inclusion Criteria
- Severe RA (indication according to Austrian labeling).
Exclusion Criteria
- According to Summary of Product Characteristics (SPC).
Data sourced from ClinicalTrials.gov (NCT00725621). 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.