Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

Study Overview
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Brief Summary
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The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.

Official Title
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Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)

Conditions
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Psoriatic Arthritis (PsA)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants 18 years or older Participants who signed an informed consent Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18 Participants naïve of abatacept and who at their physician's discretion initiate abatacept Participants meeting criteria for abatacept treatment for PsA as specified in the German label Exclusion Criteria: Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)

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 |
| --- | --- |
| Cohort 1<br>naïve of abatacept, other biologic agents and Targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs) | |
| Cohort 2<br>naïve of abatacept, who previously failed one tumor necrosis factor inhibitor (TNFi), but are naïve of any other biologic agent and tsDMARDs | |
| Cohort 3<br>naïve of abatacept, who previously failed treatment with tsDMARDs and/or biologic agents** other than a single TNFi | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity index for PSoriatic Arthritis (DAPSA) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant retention rate |  | 12 Months | 
| Proportion of concomitant treatment given |  | 12 Months | 
| Initial dosage of Abatacept given |  | At Treatment Initiation | 
| Frequency of Abatacept administration |  | 12 months | 
| Descriptive Analysis: Reasons for Abatacept initiation |  | up to 2 years prior to treatment | 
| Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD) |  | up to 2 years prior to treatment | 
| Descriptive Analysis: Socio-Demographics at Treatment Initiation |  | At Treatment Initiation | 
| Descriptive Analysis: Disease history at Treatment initiation |  | Prior to treatment | 
| Incidence of Risk factors and Comorbidities |  | At Treatment Initiation | 
| Descriptive Analysis: Baseline Characteristics |  | up to 2 years prior to treatment | 
| Descriptive Analysis: Change in participant characteristics and symptoms |  | 12 months | 
| Proportion of Rheumatologist: Geography |  | up to 2 months prior to treatment to 12 months post treatment | 
| Proportion of Rheumatologist: Type of Institution |  | up to 2 months prior to treatment to 12 months post treatment | 
| Proportion and type of treatment after abatacept discontinuation |  | 12 months | 
| Proportion of reasons for abatacept discontinuation and initiation of new therapy |  | 12 Months |