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

Completed
Conditions
Rheumatoid Arthritis
Interventions
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
Inclusion Criteria
  • Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.
Exclusion Criteria
  • episodic treatment with infliximab

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
RA patientsInfliximabPatients on maintenance therapy for RA with infliximab for \>= the past 12 months.
Primary Outcome Measures
NameTimeMethod
Dosing Interval Between the Infliximab InfusionsMeasured 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 IntervalMeasured 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 IntervalMeasured 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 StudyMeasured 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
NameTimeMethod
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

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