A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)
- Registration Number
- NCT00741104
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 363
- Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.
- episodic treatment with infliximab
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RA patients Infliximab Patients on maintenance therapy for RA with infliximab for \>= the past 12 months.
- Primary Outcome Measures
Name Time Method Dosing Interval Between the Infliximab Infusions Measured from the Remicade Questionnaire at first (and only) study visit Patients were asked as part of the Remicade questionnaire what dosing interval they were on.
Reason for Extending Dosing Interval Measured from the Remicade Questionnaire at first (and only) study visit Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.
Patient Response to Increased Dosing Interval Measured from the Remicade Questionnaire at first (and only) study visit Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.
Number of Patients Agreeing to Participate in a Dose Reduction Study Measured from the Remicade Questionnaire at first (and only) study visit As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"
- Secondary Outcome Measures
Name Time Method Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage. Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Adverse Events (AEs) Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry. This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire. Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. This is not a prespecified key secondary outcome; therefore, results will not be disclosed