Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

Study Overview
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Brief Summary
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This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.

Detailed Description
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Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.

Official Title
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Remicade Treatment Registry in Rheumatoid Arthritis I

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: Subject must have been given patient leaflet, Subject must not have ever received infliximab at the time of registration, Subject must be a good candidate for infliximab as per Summary of Product Characteristics Subject must sign the approved consent form Exclusion Criteria: None
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 |
| --- | --- |
| Rheumatoid Arthritis Patients in Slovakia<br>Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice. | Drug: Infliximab<br>* Infliximab given in accordance with the local summary of product characteristics<br>* Other names: SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment | The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity. | Baseline, Week 14, and Week 54 | 
| Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria | Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response. | Week 14 and Week 54 |