Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

Study Overview
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Brief Summary
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This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

Detailed Description
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This study population was chosen from a non-probability sample.

Official Title
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Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe RA (indication according to Austrian labeling). Exclusion Criteria: According to Summary of Product Characteristics (SPC).
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 |
| --- | --- |
| Remicade<br>Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians. | Biological: Infliximab<br>* Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.<br>* Other names: SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 16 weeks | 
| Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 16 weeks | 
| Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 102 weeks | 
| Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 102 weeks | 
| Mean Remicade Dose Per Participant |  | Maximum of 102 weeks | 
| Median Remicade Dose Per Participant |  | Maximum of 102 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy |  | 24 months maximum | 
| Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Some participants had more than one previous treatment with a DMARD. | 24 months maximum | 
| Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | 24 months maximum | 
| Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | 24 months maximum |