N/A
Completed N=33
Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)
Source: ClinicalTrials.gov NCT00724243 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment — 7.11; 2.94; 3.27 Units on a Scale
Summary
This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment |
7.11; 2.94; 3.27 | — |
| PRIMARY Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria |
27; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have been given patient leaflet,
- Subject must not have ever received infliximab at the time of registration,
- Subject must be a good candidate for infliximab as per Summary of Product Characteristics
- Subject must sign the approved consent form
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00724243). 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.