Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

Completed

• Conditions: Psoriatic Arthritis (PsA)

• Registration Number: NCT03419143
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-01
• Study Start: 2018-03-02
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

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Exclusion Criteria

• Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Activity index for PSoriatic Arthritis (DAPSA)	12 months

Secondary Outcome Measures

Name	Time	Method
Proportion of concomitant treatment given	12 Months
Initial dosage of Abatacept given	At Treatment Initiation
Participant retention rate	12 Months
Descriptive Analysis: Baseline Characteristics	up to 2 years prior to treatment
Proportion of Rheumatologist: Geography	up to 2 months prior to treatment to 12 months post treatment
Frequency of Abatacept administration	12 months
Descriptive Analysis: Change in participant characteristics and symptoms	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: Disease history at Treatment initiation	Prior to treatment
Incidence of Risk factors and Comorbidities	At Treatment Initiation
Proportion of Rheumatologist: Type of Institution	up to 2 months prior to treatment to 12 months post treatment
Proportion of reasons for abatacept discontinuation and initiation of new therapy	12 Months
Descriptive Analysis: Socio-Demographics at Treatment Initiation	At Treatment Initiation
Proportion and type of treatment after abatacept discontinuation	12 months

Trial Locations

Locations (1)

Local Institution - 0001; 🇩🇪 Nurnberg, Germany