The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)

Study Overview
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Brief Summary
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This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT study. Site investigators will conduct a chart review and complete a data collection form. The purpose of this study is to describe the treatment used and clinical outcomes of these subjects following completion of the ATTRACT trial up until their most recent assessment by the treating physicians.

Detailed Description
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Subjects were selected for this study using a non-probability sampling method.

Official Title
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The Canadian ATTRACT Follow-up Program

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Other: Retrospective Chart Review and Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have been enrolled in the two year follow-up phase of ATTRACT and have continued treatment with the site investigator Signature of informed consent. Exclusion Criteria: Not specified in the protocol.
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 |
| --- | --- |
| Cohort 1<br>Subjects previously enrolled in the ATTRACT trial from three Canadian sites. | Other: Retrospective Chart Review and Data collection<br>* Retrospective Chart Review and Data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the treatment used after completion of the ATTRACT trial in patients enrolled as subjects in the ATTRACT trial from Canadian sites. |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| To describe the long-term therapeutic response as measured by the ACR status in patients enrolled as subjects in the ATTRACT trial from Canadian sites. |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the long term safety of infliximab in patients enrolled as subjects in the ATTRACT trial from Canadian sites. |  | Adverse events will be recorded only for the period after completion of the ATTRACT follow-up. | 
| Disease Activity Score (DAS) |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Morning stiffness |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Swollen joint count |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Tender joint count |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Rheumatoid factor (RF) presence |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| C-reactive Protein (CRP) values |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Erythrocyte Sedimentation Rate (ESR) values |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Annualized X-ray Progression before and after infliximab |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Health Assessment Questionnaire |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Pain Score |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Patient Global Assessment of Disease Status |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Physician Global Assessment of Disease Status |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. | 
| Healthcare Utilization |  | There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. |