A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

Study Overview
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Brief Summary
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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
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Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.

Official Title
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A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent. Exclusion Criteria: episodic treatment with infliximab
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients<br>Patients on maintenance therapy for RA with infliximab for >= the past 12 months. | Drug: Infliximab<br>* Treatment of RA with Infliximab according to and under normal routine clinical practice.<br>* Other names: SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing Interval Between the Infliximab Infusions | Patients were asked as part of the Remicade questionnaire what dosing interval they were on. | Measured from the Remicade Questionnaire at first (and only) study visit | 
| Reason for Extending Dosing Interval | 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. | Measured from the Remicade Questionnaire at first (and only) study visit | 
| Patient Response to Increased Dosing Interval | 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. | Measured from the Remicade Questionnaire at first (and only) study visit | 
| Number of Patients Agreeing to Participate in a Dose Reduction Study | As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study? | Measured from the Remicade Questionnaire at first (and only) study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage. | This is not a prespecified key secondary outcome; therefore, results will not be disclosed | 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. | 
| Adverse Events (AEs) | This is not a prespecified key secondary outcome; therefore, results will not be disclosed | Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry. | 
| Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire. | This is not a prespecified key secondary outcome; therefore, results will not be disclosed | 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. |