N/A
N=363
A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00741104 ↗Enrolled (actual)
363
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: Primary: Dosing Interval Between the Infliximab Infusions — 121; 205; 37 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Infliximab (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2008
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. |
— | — |
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.
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.