A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis

Study Overview
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Brief Summary
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This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.

Official Title
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Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics) Exclusion Criteria: Participants who are currently included in any interventional clinical trial in RA Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Abatacept for Rheumatoid Arthritis (RA)<br>Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients continuing with abatacept treatment |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-citrullinated protein antibody (ACPA) titer |  | At baseline | 
| Concomitant treatment given with abatacept as determined by the investigator |  | Up to 12 months | 
| Dosage of abatacept as determined by the investigator |  | Up to 12 months | 
| Frequency of administration of abatacept |  | Up to 12 months | 
| Reason for abatacept treatment initiation as determined by the investigator |  | At baseline | 
| Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD) |  | Up to 12 months | 
| Socio-demographics of participants as determined by the investigator |  | At baseline | 
| Disease history of participants as determined by the investigator |  | At baseline | 
| Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia) |  | Up to 12 months | 
| Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency) |  | Up to 12 months | 
| Simplified Disease Activity Score (based on 28 joints) (DAS28) | DAS28: Swollen joint count [SJC], tender joint count [TJC], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR] | Up to 12 months | 
| Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria |  | Up to 12 months | 
| Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2) |  | Up to 12 months | 
| Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2 |  | Up to 12 months | 
| Number of patients who achieve the first remission state, DAS28 < 2.6 |  | Up to 12 months | 
| Number of Adverse Events (AE) |  | Up to 12 months | 
| Number of Serious Adverse Events (SAE) |  | Up to 12 months | 
| Health Assessment Questionnaire Disability Index (HAQ-DI) |  | Up to 12 months | 
| Existence or the absence of radiographic erosions as determined by the investigator by imaging technique |  | At baseline | 
| Existence or the absence of radiographic erosions as determined by the investigator by imaging technique |  | Up to 12 months | 
| Rheumatoid factor (RF) |  | Up to 12 months | 
| Patient global assessment (PGA) |  | Up to 12 months | 
| Evaluator global assessment (EGA) |  | Up to 12 months | 
| Clinical disease activity index (CDAI) |  | Up to 12 months | 
| Simple disease activity index (SDAI) |  | Up to 12 months |