N/A
Completed N=363
A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)
Source: ClinicalTrials.gov NCT00741104 ↗Enrolled (actual)
363
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Dosing Interval Between the Infliximab Infusions — 121; 205; 37 participants
Summary
This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosing Interval Between the Infliximab Infusions |
121; 205; 37 | — |
| PRIMARY Reason for Extending Dosing Interval |
24; 31; 28; 14; 0; 9 | — |
| PRIMARY Patient Response to Increased Dosing Interval |
4; 75 | — |
| PRIMARY Number of Patients Agreeing to Participate in a Dose Reduction Study |
139; 222 | — |
| SECONDARY Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage. |
— | — |
| SECONDARY Adverse Events (AEs) |
— | — |
| SECONDARY Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.
Exclusion Criteria
- episodic treatment with infliximab
Data sourced from ClinicalTrials.gov (NCT00741104). 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.